CLIANTHA RESEARCH LIMITED
Opposite Pushparaj Towers, Near Judges Bungalows, Bodakdev, Ahmedabad-380 054.

Respiratory Research Papers

Effects of ectoine containing nasal spray and eye drops on symptoms of seasonal allergic rhinoconjunctivitis

Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus twomonotherapy intranasal mometasone formulattons.

A Pilot Study Investigating Clinical Responses and Biological Pathways of Azelastine/Fluticasonein Nonallergic Vasomotor Rhinitis before and after Cold Dry Air Provocation.

Allergen exposure chambers: harmonizing current concepts and projecting the needs for the future - an EAACI Position Paper.

Efficacy of a short course of specific immunotherapy in patients with allergic rhinoconjunctivitisto ragweed pollen.

A proof-of-concept study of the effect of a novel H3-receptor antagonist in allergen-induced nasalcongestion.

Double-blind, placebo-controlled, dose-ranging study of new recombinant hypoallergenic Bet v 1in an environmental exposure chamber.

Fel d 1-derived peptide antigen desensitization shows a persistent treatment effect 1 year afterthe start of dosing: a randomized, placebo-controlled study.

Provocation of nonallergic rhinitis subjects in response to simulated weather conditions using an environmental exposure chamber model.

Patel P, Salapatek AM, Talluri R, Tantry S. Pharmacokinetics of intranasal mometasone in the fixed-dose combination GSP301 versus two monotherapy intranasal mometasone formulations. Allergy Asthma Proc 2018; 39. 232-239.

Singh U, Bernstein J, Lorentz H, Sadoway T, Nelson V, · Patel P, Salapatek A.M. A Pilot Study Investigating Clinical Responses and Biological Pathways of Azelastine/Fluticasone in Nonallergic Vasomotor Rhinitis before and after Cold Dry Air Provocation. Int Arch Allergy Immunol 2017; 173:153-164.

Pfaar O, Calderon MA, Andrews CP, Angjeli E, Bergmann KC, Bønløkke JH, de Blay F, Devillier P, Ellis AK, Gerth van Wijk R et al. 2016. Allergen Exposure Chambers (AEC): harmonizing current concepts and projecting the needs for the future - an EAACI Position Paper. Allergy 2017; 72(7):1035-1042.

Couroux P, Patel D, Armstrong K, Larch M, Hafner RP. Fel d 1-derived synthetic peptide immuno-regulatory epitopes show a long-term treatment effect in cat allergic subjects. Clin. Exp. Allergy 2015; 45, 974-981.

Patel P, Holdich T, Fischer von Weikersthal-Drachenberg K, Huber B. Efficacy of a short course of specific immunotherapy in patients with allergic rhinoconjunctivitis to ragweed pollen. J Allergy Clin Immunol 2014; 133(1):121-9.e1-2.

Creticos P, Esch R, Couroux P, Gentile D, D’Angelo P, Whitlow B, Alexander M, Coyne T. Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis. J Allergy Clin Immunol 2014; 133:751-8.

Barchuk W, Salapatek A, Ge T, D’Angelo P, Liu X. A proof-of-concept study of the effect of a novel H3-receptor antagonist in allergen-induced nasal congestion. J Allergy Clin Immunol. 2013; 132(4):838-46.e1-6.

Meyer W, Narkus A, Salapatek A, Hafner D. Double-blind, placebo-controlled, dose-ranging study of new recombinant hypoallergenic Bet v 1 in an environmental exposure chamber. Allergy 2013; 68:724-731.

Patel D, Couroux P, Hickey P, Salapatek A, Laidler P, Larche M, Hafner R. Fel d 1-derived peptide antigen desensitization shows a persistent treatment effect 1 year after the start of dosing: A randomized, placebo-controlled study. J Allergy Clin Immunol 2012; 131:103-109.

Bernstein J, Salapatek A, Lee J, Nelson V, Wilson D, D’Angelo P, Tsitoura D, Murdoch R, Patel D. Provocation of nonallergic rhinitis subjects in response to simulated weather conditions using an environmental exposure chamber model. Allergy Asthma Proc 2012; 33:333-340.

Salapatek AM, Lee J, Patel D, D’Angelo P, Liu J, Zimmerer RO, Pipkin JD. Solubilized nasal steroid (CDX-947) when combined in the same solution nasal spray with an antihistamine (CDX-313) provides improved, fast-acting symptom relief in patients with allergic rhinoconjunctivitis. Allergy Asthma Proc 2011; 32:221-229.

Corren J, Wood R, Patel D, Zhu J, Yegin A, Dhillon G, Fish J. Effects of omalizumab on changes in pulmonary function induced by controlled cat room challenge. J Allergy Clin Immunol 2011; 127:398-405.

Baena-Cagnani CE, Patel PEfficacy and long-term safety of mometasone furoate nasal spray in children with perennial allergic rhinitis. Curr Med Res Opin 2010; 26(9):2047-2055.

Salapatek AM, Patel P, Gokul G, Santosh VT. Mometasone furoate nasal spray provides early, continuing relief of nasal congestion and improves nasal patency in allergic patients. Am J Rhinol Allergy 2010; 24(6):433-438.

Katial, RK, Salapatek, AM, Patel, P. Establishing the onset of action of intranasal corticosteroids: is there an ideal study design? Allergy Asthma Proc 2009; 30:595-604.

Patel P, Patel D. Efficacy comparison of levocetirizine vs montelukast in ragweed sensitized patients. Ann Allergy Asthma Immunol 2008; 101:287-294.

Philip G, Williams-Herman D, Patel P, Weinstein SF, Alon A, Gilles L, et al. Efficacy of montelukast for treating perennial allergic rhinitis. Allergy Asthma Proc 2007; 28:296-304.

Patel P, D'Andrea C, Sacks HJ. Onset of action of azelastine nasal spray compared with mometasone nasal spray and placebo in subjects with seasonal allergic rhinitis evaluated in an environmental exposure chamber. Am J Rhinol 2007; 21:499-503.

Patel P, Roland PS, Marple BF, Benninger PJ, Margalias H, Brubaker M, et al. An assessment of the onset and duration of action of olopatadine nasal spray. Otolaryngol Head Neck Surg 2007; 137:918-924.

Patel, P, Salapatek, AM. Pollinex Quattro: a novel and well-tolerated, ultra short-course allergy vaccine. Expert Rev Vaccines 2006; 5:617-629.

Patel P, Philip G, Yang W, Call R, Horak F, LaForce C, et al. Randomized, double-blind, placebo- controlled study of montelukast for treating perennial allergic rhinitis. Ann Allergy Asthma Immunol 2005; 95:551-557.

Chapman KR, Patel P, D'Urzo AD, Alexander M, Mehra S, Oedekoven C, et al. Maintenance of asthma control by once-daily inhaled ciclesonide in adults with persistent asthma. Allergy 2005; 60:330-337.

Grimfeld A, Holgate ST, Canonica GW, Bonini S, Borres MP, Adam D, Canseco Gonzalez C, Lobaton P, Patel P, Szczekik A, Danzig MR, Roman I, Bismut H, Czarlewski W. Prophylactic management of children at risk for recurrent upper respiratory infections: the Preventia I Study. Clin Exp Allergy 2004; 34:1665-1672.

Newhouse MT, Patel P, Parry-Billings M. Protection against methacholine-induced bronchospasm: salbutamol pMDI versus Clickhaler DPI. Eur Respir J 2003; 21:816-820.

Price DB, Rouleau MY, Fletcher CP, Patel P, Olivenstein R, Myhr L, et al. Use of Montelukast in tapering inhaled corticosteroid therapy: an open-label, 48-week trial. Curr Ther Res Clin Exp 2001; 62:743-755.

Day J, Alexander M, Drouin M, Frankish C, Mazza J, Moote W, Patel P, Ramsdale H, Yang W. Budesonide aqueous nasal spray and pressurised metered dose inhaler in the treatment of adult patients with seasonal allergic rhinitis. Am J Rhinol 1997; 11:77-83.

Patel P. IgG subset deficiency and recurrent infections in childhood. Reviews in Allergy 1990

Patel P, Henning R, Atkinson S, Dent PB, Dolovich J. Intoxications from Megadose Vitamin A for Asthma in Child. CMAJ 1988; 139:755-756.

Bousquet J, Meltzer E, Couroux P, Koltun A, Kopietz F, Munzel U, Christian Kuhl H, Tung Nguyen D, Salapatek AM, Price D. Onset of Action of the Fixed Combination Intranasal Azelastine-Fluticasone Propionate in an Allergen Exposure Chamber. J Allergy Clin Immunol Pract 2018; pii S2213-2198(18)30058-8.

Salapatek AM, Small C, Lorentz H, Beattie E, Nelson V, Couroux P. Correlation between Overall Allergy Symptom Visual Analog Scale (VAS) Scores and Total Symptom Scores (TSS) in Subjects with Ragweed-Induced Allergic Rhinitis in an Environmental Exposure Chamber (EEC). J Allergy Clin Immunol 2018; 141. AB403.

Patel P, Salapatek AM, Tantry S. Rapid Onset of Action on Nasal Symptoms and Ocular Symptom Relief With Olopatadine/Mometasone Combination Nasal Spray in a Ragweed Environmental Exposure Chamber. J Allergy Clin Immunol 2018; 141. AB69.

Beattie E, Small C, Lorentz H, Nelson V, Couroux P, Salapatek AM. Repeatability of Total Nasal Symptom Scores (TNSS) in Allergic Rhinitis Individuals Using an Electronic Diary during Environmental Exposure Chamber (EEC) Visits. J Allergy Clin Immunol 2018; 141. AB403.

Nelson V, Beattie E, Couroux P. Salapatek AM. OR012 Simultaneous aerosolization of two perennial allergens in a novel, naturalistic Environmental Exposure Chamber (EEC) model. Ann Allergy Asthma Immunol 2017; 119. S3.

Patel P, Salapatek AM, Agarwal P, Tantry S. P435 Olopatadine/mometasone combination nasal spray improves seasonal allergic rhinitis symptoms in a ragweed environmental exposure chamber. Ann Allergy Asthma Immunol 2017; 119. S90.

Zizek W, Sadoway T, Salapatek AM, Nelson V. Truly sympomatic grass-allergic subjects screened in an enironmental exposure chamber. J Allergy Clin Immunol 2017; 139(2):AB157.

Sadoway T, Zizek W, Salapatek AM, Nelson V. Reduction of re-aerosolized household allergens during vacuuming with a product regime in an environmental exposure chamber (EEC) model. J Allergy Clin Immunol 2017; 139(2):AB120.

Patel S, Zizek W, Sadoway T, Salapatek AM, Nelson V. Screening for non-allergic rhinitis improves patient selection towards improved outcomes. Ann Allergy Asthma Immunol 2016; 117(5):S13.

Lorentz H, Tenorio N, Nelson V, Sadoway T, Patel P, Salapatek AM. Study design considerations to improve patient selection in CAPT studies. Ann Allergy Asthma Immunol 2016; 117(5):S117.

Patel P, Salapatek AM, Piyush A, Talluri RS, Tantry SK. Pharmacokinetics of olopatadine administered as GSP301 nasal spray versus olopatadine monotherapy. Ann Allergy Asthma Immunol 2016; 117(5):S114–S115.

Patel P, Salapatek AM, Piyush A, Talluri RS, Tantry SK. Pharmacokinetics of olopatadine administered as GSP301 nasal spray versus mometasone monotherapy. Ann Allergy Asthma Immunol 2016; 117(5):S115.

Couroux P, Cohrt AK, Walmar M, Steffensen MA, Andersen JS, Salapatek AM. The SQ tree SLIT-tablet reduces rhinoconjunctivitis symptoms during challenge with birch pollen in an environmental exposure chamber. Allergy 2016; 72(S103):372.

Couroux P, Cohrt AK, Walmar M, Steffensen MA, Andersen JS, Salapatek AM. The SQ tree SLIT- tablet containing allergen extract from birch pollen reduces rhinoconjunctivitis symptoms caused by oak pollen - A proof of concept trial. Allergy 2016; 72(S103):373.

Salapatek AM, Buck J, Nandkeshore H, Shields K, Patel P. The “Hub-and-Spoke” Approach to Large Multicenter Allergy Trials Utilizing the Mobile Environmental Exposure Chamber System (mEEC): Setup and Screening for an Immunotherapy Study Conducted in the US Northeast and US Midwest. Allergy 2016; 71(S102):175.

Singh U, Bernstein JA, Lorentz H, Sadoway T, Nelson V, Patel P, MD, Salapatek, AM. Reduction of Substance-P Mediated Neuronal Hyper-Reactivity By Dymista® (Azelastine/Fluticasone) Correlates with Decreased Cough Frequency in Non-Allergic Rhinitis. J Allergy Clin Immunol 2016; 137(2):AB261.

Patel S, Nelson V, Sadoway T, Couroux P, Salapatek AM. Skin Prick Testing Alone Is Not A Good Predictor Of Allergy Symptom Severity In Grass Allergic Patients. J Allergy Clin Immunol 2016; 137(2):AB255.

Sadoway T, Nelson V, Patel S, Couroux P, Salapatek AM. Field Scores of Allergic Individuals Correlate Positively with Self-Reported Outdoor Exposure Collected Using an Electronic Patient Data Acquisition Tablet (ePDAT™). J Allergy Clin Immunol 2016; 137(2):AB123.

Panchal D, Wilson D, Sadoway T, Nelson V, Patel P, Salapatek AM. Electronic Patient Data Acquisition Tablet (ePDAT™) Geofencing Capabilities Allows for Subject Compliance and Pollen Exposure Monitoring Leading to Improved Data Quality in Seasonal Allergy Field Trials. J Allergy Clin Immunol 2016; 137(2):AB123.

Nelson V, Sadoway T, Pathmanapan S, Patel P, Salapatek AM. Identifying birch allergic patients:use of skin prick test and IgE classifications. Allergy 2015; 70:174-174.

Lorentz H, Sadoway T, Nelson V, Patel P, Nandkeshore H, Salapatek AM. An observational study to determine the impact of presentation order on symptom scores from patients exposed to grass allergen in a mobile environmental exposure chamber (mEEC). Allergy 2015; 70(S101):525-526.

Sadoway T, Nelson V, Pathmanapan S, Patel P, Salapatek AM. Prevalence of skin prick test and IgE positive subjects in the Greater Toronto Area (GTA), Canada. Allergy 2015; 70(S101):565- 566.

Murdoch RD, Bareille P, Ignar D, Mark S, Miller SR, Gupta A, Salapatek AM, Patel P. Once-daily dosing of levocabastine has comparable efficacy to twice-daily dosing in the treatment of allergic rhinitis assessed in an allergen challenge chamber. Int J Clin Pharmacol 2015; 53(10):811.

Nelson, V, Couroux P, Sadoway T, Patel P, Salapatek AM. Comorbidity of allergic rhinitis and asthma to birch allergen in an environmental exposure chamber. Eur Respir J 2015; 46(Suppl. 59):PA4020.

Liu J, Liang Q, Peng X, Oldham M, Rostami A, Wagner KA, Gillman IG, Salapatek AM, Sarkar M. Are chemical constituents exhaled in a room where e-vapor products are used? CORESTA 2015

Salapatek, AM, Couroux P, Nelson V, Patel P. Should patients with mild asthma be excluded from allergic rhinitis drug trials? Eur Respir J 2015; 46(Suppl. 59):PA4026.

Sadoway T, Pathmanapan S, De Lazzari P, Nelson V, Salapatek AM. Investigating the effect of chemical cleaners on the reduction of perennial household allergens in a soft surface, environmental exposure chamber (EEC) model. Ann Allergy Asthma Immunol 2015; 115(Suppl.):A20.

Nelson V, Pathmanapan S, Sadoway T, Recker S, Lorentz H, Salapatek A. Significant variability in SPT results from different commercial mold allergen extracts can present challenges to allergy diagnosis and subject recruitment in clinical trials. Ann Allergy Asthma Immunol 2015; 115(Supplement):A51

Nelson V, Lorentz H, Sadoway T, Patel P, Couroux P, Salapatek A, Bernstein JA. A pilot study investigating Dymista for treatment of non-allergic rhinitis (NAR) using a cold dry air (CDA) environmental exposure chamber (EEC) model. Ann Allergy Asthma Immunol 2015; 115(Supplement):A119

Bernstein JA, Singh U, Lorentz H, Sadoway T, Nelson V, Patel P, Salapatek AM. Reduction of substance P in nasal lavage fluid by Dymista after cold dry air challenge using a non-allergic rhinitis environmental exposure chamber (EEC). Ann Allergy Asthma Immunol 2015; 115(Supplement):A119.

Patel R, Beattie E, Modeste E, Salapatek AM. Healthy, non-allergic subjects do not develop allergic symptoms when co-mingled with symptomatic allergic subjects and exposed to airborne allergen in an Environmental Exposure Chamber (EEC). J Allergy Clin Immunol 2015; 135(2):AB246.

Hafner, R., Salapatek, A., Larché, M., Ahenkorah, B., Patel, P., & Pawsey, S. Initial Evidence of Sustained Efficacy of House Dust Mite Synthetic Peptide Immuno Regulatory Epitopes 2 Years after a Short Course of Treatment in House Dust Mite (HDM) Allergic Subjects. J Allergy Clin Immunol 2015; 135(2):AB142.

Sadoway T, Buck J, Salapatek AM, Patel P. Age and sex are important considerations for studies involving reactivity to allergenic stimuli. J Allergy Clin Immunol 2015; 135(2):AB134.

Remtullah R, Sadoway T, Buck J, Salapatek AM, Patel P. Allergic response to IgE and Skin Prick Test Varies by Ethnicity. J Allergy Clin Immunol 2015; 135(2):AB52.

Salapatek AM, Beattie E, Patel P. A New Naturalistic Asthma Model in the Environmental Exposure Chamber to Study Mild Asthmatics Safely and Consistently. ERS 2014.

Salapatek AM, Beattie E, Tang Z, Dabouz F, Patel P. A Study of House Dust Mite-Specific Immunotherapy (HDM IT) Reveals that Patient Reported Allergic Rhinoconjunctivitis Symptom Scores in an Environmental Exposure Chamber (EEC) are Highly Correlated with the Symptoms in the Field. EAACI 2014.

Patel R, Beattie E, Salapatek AM. Analysis of previous studies and general screening revealed differences in correlation level between patient skin prick test (SPT) and patient IgE levels and that they vary from moderate to low for different allergies both seasonal and perennial allergen exposure. EAACI 2014.

Erpenbeck VJ, Salapatek AM, Patel P, Sanni J, Dubois G, Zhou P, Perry S, Larbig M. Efficacy and safety of 10 day treatment with the CRTh2 antagonist QAV680 evaluated in patients with allergic rhinitis in an environmental exposure chamber. J Eur Resp 2014.

Salapatek AM, Nelson V, Patel P. Do Residual Wheal Skin Prick Test Responses to Perennial and Seasonal Allergens Correlate with their Specific IgE Levels in Allergic Subjects? J Allergy Clin Immunol 2014; 133(2):AB102.

Erpenbeck, VJ, Salapatek AM, Patel P, Carew D, Dubois G, Perry S, Larbig M. QAV680, cetirizine and their combination reduce nasal symptoms in patients with intermittent allergic rhinitis in an environmental exposure chamber. J Eur Resp 2014; 44.

Wilson D, Patel P, Boczula K, Salapatek AM. Electronic Patient Data Acquisition Tablet (ePDAT) Provides Customized, Flexible Scheduling for Collecting Electronic Patient Reported Outcomes (ePRO) with high Usability and Compliance Ideal For Use in Single and Multicenter Environmental Exposure Chamber (EEC) Studies. J Allergy Clin Immunol 2014; 133(2):AB127.

Salapatek AM, Buck J, Patel P. A Case Study in Effective Innovative Strategic Multi-modal Recruitment Strategies in Difficult-to- Recruit Patient Populations: Study of Safety and Tolerability of Novel SLIT in an Adolescent Population. World Allergy Organ J 2014; 7(S1):3.

Salapatek AM, Nelson V, Wilson D, Patel P. An Electronic Patient Data Acquisition Tablet (ePDAT™) Ideal for Rapid Onset-of-Action Data. Ann Allergy Asthma Immunol 2013; 111(5):A114-A114.

Wilson D, Nandkeshore H, Patel P. Development and validation of an electronic patient data acquisition tablet (ePDAT) for allergy symptom collection in an environmental exposure chamber (EEC) and at-home. Allergy 2013; 68(Suppl. 97):466.

Salapatek AM, Patel P. Symptom response phenotyping in the environmental exposure chamber improves screening and selection of patients with clinically relevant allergy symptomology for participation in allergy trials. EAACI 2013.

Nandkeshore H, Shields K, Patel P. Validation of a unique mobile environmental exposure chamber system (mEEC) for use in multiple locations in a multicenter mEEC allergy trial demonstrates accuracy and reproducibility in grass pollen aerosolization after mEEC disassembly, relocation and reassembly. Allergy 2013; 68(Suppl. 97):193.

Nandkeshore H, Recker S, Patel P, Salapatek AM. Electronic Patient Acquisition Tablet Demonstrates a High Level of User Acceptability and Accommodation by Patients with Allergic Rhinitis Studied in an Environmental Exposure Chamber. Allergy 2013; 68(Suppl. 97):360.

Wilson D, Wilson G, Patel P. A novel validated electronic patient data acquisition tool standardizes patient report outcomes (PRO) data acquisition across multi-center environmental exposure chamber and field studies. J Allergy Clin Immunol 2013; 131:AB226.

Patel P, Nandkeshore H, Shields K. Mobile natural exposure chamber technology standardizes controlled environmental exposure chamber challenges across multicenter national and international allergy trials. J Allergy Clin Immunol 2013; 131:AB188.

Nandkeshore H, Shields K, Recker S, Patel P. Novel natural exposure chamber technology mimics environmental allergen levels whilst providing well-controlled airborne allergen exposures with high specificity to allergic patients. J Allergy Clin Immunol 2013; 131:AB226.

Salapatek A, Camuso N, Ahmed A, Nelson V. A retrospective analysis of anti-allergy drug efficacy tested in an environmental exposure chamber (EEC) compared to that observed in the traditional allergy field trials demonstrates the clinical relevance of allergen exposure models. J Allergy Clin Immunol 2012; 129:AB207.

Salapatek A, Gopalan G. Mometasone furoate significantly relieves rhinorrhea assessed in an environmental exposure chamber. Allergy 2012; 67(s96):307-451.

Meyer W, Narkus A, Salapatek A, Patel D, Mussler S, Haefner D. Efficacy and safety of four dose regimes of a hypoallergenic recombinant birch pollen major allergen (rBet v 1-FV) in birch pollen allergic patients studied in an environmental exposure chamber. Allergy 2012; 67(s96):1- 97.

Larche M, Patel D, Patel P, Salapatek A, Laidler P, Hafner R. Safety and efficacy of Fel d 1 derived peptide immunotherapy in a double-blind, placebo-controlled environmental exposure chamber study. Allergy 2012; 67(s96):1-97.

Hafner R, Efthimiou J, Salapatek A, Couroux P, Patel D, Larche M. Persistent treatment effect on ocular and nasal symptoms of cat allergy 1 year after 4 doses of Fel d 1 peptide immunotherapy. Allergy 2012; 67(S96):1-97.

Hafner RP, Salapatek A, Patel D, Larche M, Laidler P. Validation of peptide immunotherapy as a new approach in the treatment of allergic conjunctivitis: the clinical benefits of treatment with Amb a 1 derived T cell epitopes. J Allergy Clin Immunol 2012; 129:AB368.

Hafner RP, Efthimiou J, Salapatek A, Patel D, Larche M. Persistent treatment effect achieved at one year after 4 doses of Fel d 1-derived peptide immunotherapy in an environmental exposure chamber (EEC) Model of cat allergy. J Allergy Clin Immunol 2012; 129:AB144.

Camuso N, Zafar S, Najera N, Liac A, Aguirre G, Salapatek A. Controlled allergen exposure in the environmental exposure chamber (EEC) results in a late phase inflammatory response evidenced by increased eosinophils in the upper airway of allergic patients. J Allergy Clin Immunol 2012; 129:AB48.

Wilson D, Camuso N, Salapatek A. The mass of cat dander aerosolized is a good predictor of the real-time airborne Fel d 1 concentration in an Environmental Exposure Chamber (EEC). J Allergy Clin Immunol 2011; 127:AB21.

U.S Food and Drug Administration (2011, May 11). Center for Biologics Evaluation and Research Allergenic Products Advisory Committee. Open Public Hearing Speaker Anne Marie Salapatek. Pg 146-156. Retrieved from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVa ccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/UCM258587.pdf

Tort MJ, Ornberg R, Lay B, Soong F, Salapatek A. Ocular allergen exposure: a naturalistic environmental exposure chamber model versus a direct instillation model. Annal Allergy Asthma and Immunol 2011; 107:A46.

Salapatek A, Bates M, Bilstein A, Patel D. Ectoin(R), a novel, non-drug, extremophile-based device, relieves allergic rhinoconjuncitivitis symptoms in patients in an Environmental Exposure Chamber model. J Allergy Clin Immunol 2011; 127:AB202.

Patel D, Patel N, Lee J, Couroux P, Hafner R, Salapatek A. Mild Asthmatic Patients' Responses to a Repeated, Low Dose, Allergen Challenge in an Environmental Exposure Chamber (EEC) Demonstrate a Consistent Decrease in FEV1 and Increase in Asthma Symptoms. ERS Annual Conference 2011.

Patel D, Lee J, Wilson D, Camuso N, Salapatek A. Repeated low-dose aerosolized dust mite allergen exposure in asthmatic and non-asthmatic dust mite allergic patients in an Environmental Exposure Chamber induces specific asthma symptoms as well as allergic rhinoconjuncitivitis symptoms. J Allergy Clin Immunol 2011; 127:AB20.

Patel D, Bernstein DI, Plunkett G, Erskine R, Tholstrup B Tolstrup H., Salapatek A. Tolerability and efficacy of sublingual immunotherapy in cat allergic subjects studies in an environmental exposure chamber. Annals Allergy Asthma and Immunol 2011; 107:A105.

Lee J, Wilson D, Camuso N, Patel D, Salapatek A. Exposure to consistent and controlled levels of aerosolized dust mite allergen evokes ocular symptoms in dust mite allergic patients. J Allergy Clin Immunol 2011; 127:AB150.

Camuso N, Wilson D, Lee J, Salapatek A. Real-time particle counts provide a reliable indication of airborne dust mite allergen (Der p 1) concentration and ensure controlled and safe exposure for dust mite allergic patients in an Environmental Exposure Chamber (EEC) model. J Allergy Clin Immunol 2011; 127:AB20.

Camuso N, Lee J, Nelson V, Salapatek A. Novel natural cat allergen disturbance model in an environmental exposure chamber mimics patients’ everyday exposure. Annals Allergy, Asthma and Immunol 2011; 107:A7.

Wilson D, Lee J, Camuso N, Patel D, Salapatek A. Dust Mite Allergic (DMA) Patients with Sensitivity to Dermatophagoides pteronyssinus (Der p) and/or Dermatophagoides farinae (Der f) Respond with Significant and Reproducible Nasal Symptoms to Aerosolized Der p in an Environmental Exposure Chamber (EEC) Model. Ann Allergy Asthma Immunol 2010; 105.

Wilson D, Lee J, Camuso N, Patel D, Salapatek AM. Dust mite allergic (DMA) patients with sensitivity to dermatophagoides pteronyssinus (DER P) and/or dermatophagoides farina (DER F) respond with significant and reproducible nasal symptoms to aerosolized DER P in an environmental exposure chamber (EEC) model. Ann Allergy Asthma Immunol 2010; 105(5):A35.

Salapatek AM, Wilson D, Patel D, Bernstein J, D'Angelo P, Lee J: Phenotyping Non-Allergic Rhinitis (NAR) Patients: Application of the Major Non-Allergic Rhinitis (NAR) Triggers under Controlled Conditions of an Environmental Exposure Chamber (EEC) reveal NAR Patient Heterogeneity. J Allergy Clin Immunol 2010; 125:AB192.

Salapatek AM, Wilson D, Liu J, Song Y, D'Angelo P, Patel P, et al. The Non-Allergic Rhinitis (NAR) Environmental Exposure Chamber (EEC) Model Evokes Consistent and Significant Nasal Symptoms in NAR Patients but not in Healthy Normal Volunteers (HNV). Allergy 2010; 65:34.

Nelson V, McCue S, Salapatek AM: An Aerosolized Cat Allergen Environmental Exposure Chamber (EEC) Model to Study Cat Allergic Patients: Assessment of Airborne Fel d 1 Concentration in Real-time ensures Controlled Patient Exposure to Cat Allergen. J Allergy Clin Immunol 2010; 125:AB128.

Lee, JS, Wilson, D, Patel, D, Bernstein, JA, D'Angelo, P, Salapatek, AM. An Ideal clinical Non- Allergic Rhinitis (NAR) model in an Environmental Exposure Chamber (EEC) induced significant rhinitis symptoms which affects Quality of Life of NAR patients. Am J Respir Crit Care Med 2010; 181:A4207.

Lee J, Wilson D, Camuso N, Patel D, Salapatek AM. Controlled Aerosolized Dust Mite Allergen (Der p) Exposure in Environmental Exposure Chamber (EEC) Induced Significant Allergy Symptoms in Dust Mite Allergic Patients. Ann Allergy Asthma Immunol 2010; 105.

Zimmerer RO, Jr., Pipkin JD, Salapatek AM, D'Angelo P, Bates M, Patel D, Patel P: Captisol- Enabled Budesonide + Azelastine HCl Nasal Spray Significantly Reduces Total Symptoms Scores (TSS) Compared to Placebo in Ragweed Allergic Patients in an Environmental Exposure Chamber (EEC) Model. Presented at the RDD Europe Meeting 2009.

Smith M: New method tackles non-allergic rhinitis: Interview with AM Salapatek. In MedPage. Miami Beach; 2009.

Salapatek AM, D'Angelo P, Liu J, McCue S, R Z, J P: Novel Solubilization of Azelastine and Budesonide with Captisol in a Convenient Combination Nasal Spray Format Provides Faster and Greater Nasal Symptom Relief than Either Captisol-Enabled-Budesonide or a Marketed Budesonide Product Alone: A Meta-Analysis of Two Environmental Exposure Chamber (EEC) Studies. Allergy 2009; 64:596.

Salapatek AM, Wilson D, Lee J, Pozza L, Bernstein J, Patel D, Patel P: Validation of a Novel Clinical Non-Allergic Rhinitis (NAR) Model to Evoke Nasal Symptoms in an Environmental Exposure Chamber (EEC): Part 1 - Static and Dynamic Temperature Shift Regimes. Allergy 2009; 64:210- 211.

Salapatek AM, Patel P, Schulze J, Weikersthal-Drachenberg KFv, Zielen S: Comparison of outcomes following ultra short course specific immunotherapy (uSCIT) in juvenile and adult patients with asthma. Proceedings of the XXVIIth Congress of the European Academy of Allergology and Clinical Immunology (EAACI);Jun 7-11;Barcelona, Spain. 2008.

Salapatek AM, Patel P, Patel D, Pipkin J, Zimmerer R: Captisol-Enabled® Budesonide Provides Fast-, Long- Acting Relief of Allergic Rhinoconjunctivitis Symptoms: Evidence from a Clinical Trial Shows Significant Total Symptom Score (TSS) and Total Ocular Symptom Score (TOSS) Reduction with Captisol-Enabled® Budesonide Compared to Rhinocort Aqua® and Placebo in Ragweed Allergic Patients Studied in an Environmental Exposure Chamber (EEC) Model. Ann Allergy Asthma Immunol 2009; 102.

Salapatek AM, Patel P, Gopalan G, Varghese S: Acoustic rhinometry nasal patency assessment: Mometasone furoate nasal spray relieves nasal congestion in allergic patients. Ann Allergy Asthma Immunol 2009; 102.

Salapatek AM, Nelson V, Patel P, McCue S: Assessment of total nasal symptom score (TNSS) during the validation of aerosolized cat dander in an environmental exposure chamber (EEC) clinical model. Am J Respir Crit Care Med 2009; 179:A5704.

Salapatek AM, McCue S, Zimmerer R, Pipkin J: Complexed steroid (CDX-947) and in combination with antihistamine (CDX-313) provide improved efficacy and onset of action in patients with allergic rhinitis in two Environmental Exposure Chamber (EEC) studies. Ann Allergy Asthma Immunol 2009; 103.

Salapatek AM, McCue S, R.O. Zimmer J, Pipkin JD: Quality of life improved in ragweed allergic patients treated with captisol-enabled budesonide+azelastine nasal solution (CDX-3213) compared to placebo and reference treatment(AS+RA) using an Environmental Exposure Chamber-specific Rhinoconjunctivits Quality of Life Questionnaire (EEC-QOL). Ann Allergy Asthma Immunol 2009; 103.

Salapatek AM, D'Angelo P, Bates M, Patel D, Patel P, Pipkin J, Zimmerer R: Novel Combination Product Captisol-Enabled® Budesonide+Azelastine HCl Provides Fast, Long-lasting Relief of Allergic RhinitisSymptoms (Total Nasal Symptom Score (TNSS) and Individual Nasal Symptoms Scores (NSS)) in Ragweed Allergic Patients Studied in an Environmental Exposure Chamber (EEC) Model. J Allergy Clin Immunol 2009; 123:S130.

Salapatek AM, Patel, P, Gopalan, G, Varghese S: Nasal congestion relief in seasonal allergic rhinitis (AR) with mometasone furoate nasal spray (MFNS) measured with acoustic rhinometry (AcR) and subjective symptom scoring correlates with overall quality of life (QOL). Ann Allergy Asthma Immunol 2009; 102:A13.

Pozza LM, Salapatek AM, Soong F, Wilson D, Patel D, Patel P: Examination of the nasal symptom response to conjunctival allergen challenge using subjective and objective measures of nasal congestion. J Allergy Clin Immunol 2009; 123:S203.

Patel S, Salapatek AM, Shah C, Patel P: Pollinex Quattro Grass immunotherapy treatment romotes beneficial immune response in patients independent of their skin prick test (SPT) sensitivity and IgG status at baseline CSACI 2009.

Patel P, Salapatek AM, Shah C, Weikersthal-Drachenberg KFv, Stollewerk D: Comparison of Efficacy of conventional Subcutaneous Immunotherapy (SCIT), Ultra short SCIT (uSCIT), and Sublingual Immunotherapy (SLIT): Results of a Multicentre Observational Study. Allergy Asthma Clin Immunol 2009.

Patel P, Salapatek AM, Shah C, Rabe U, Hanfland J, Fiedler G: Improvement in quality of life for patients with tree pollen-realted rhinaconjunctivitis and asthma after ultra short course specific immunotherapy (uSCIT) Pollinex Quattro (PQ). CSACI 2009

Patel P, Salapatek AM, DuBuske L, Weikersthal-Drachenberg KFv: The Benefit-Risk Balance of Subcutaneous Immunotherapy (SCIT) for Seasonal Allergic Rhinitis (SAR). Allergy Asthma & Clin Immunol 2009.

Patel P, Salapatek AM, D'Angelo P, Bates M, Patel D, Zimmer R, Pipkin J: The Combination Product Captisol-Enabled® Budesonide+Azelastine HCl Nasal Spray Provides Significant, Long- lasting Relief of Ocular Allergy Symptoms in Ragweed Allergic Patients Studied in an Environmental Exposure Chamber (EEC) J Allergy Clin Immunol 2009; 123:s130.

Patel P, Salapatek AM, Calderon M, Weikersthal-Drachenberg KFv: Serious adverse events and the incidence of anaphylaxis in specific immunotherapy (SIT) preparations CSACI 2009.

Patel P, Bates M, Liu J, D’Angelo P, Salapatek AM: Trials in an Environmental Exposure Chamber (EEC) can be performed In- or Out- of the natural pollen season: A randomized, double-blind, placebo-controlled, two-way crossover study in patients with SAR indicates no difference in efficacy outcomes In- or Out- of the pollen season. Ann Allergy Asthma Immunol 2009; 102:A12.

Nelson V, McCue S, Salapatek AM: An Environmental Exposure Chamber (EEC) Allergy Headache Model: Retrospective study of development of allergy and headache in EEC studies of patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol 2009; 103:A48.

Nelson V, McCue S, Salapatek AM, Chapman M, P. P: Validation of Fel d 1 Exposure in a Well- Controlled Aerosolized Cat Allergen Environmental Exposure Chamber (EEC). J Allergy Clin Immunol 2009; 123:S1:S233.

McCue S, Nelson V, Wilson D, Patel D, Salapatek AM: Individual nasal symptoms increase in cat allergic subjects when exposed to Fel d 1 in a validated aerosolized cat dander environmental exposure chamber (EEC) clinical model. Ann Allergy Asthma Immunol 2009; 103:A47.

McCue S, Nelson V, Chapman M, Freihaut J, Patel P, Salapatek AM: Fel d 1 exposure in a natural cat allergen challenge room (CACR): Results using a purified allergen standard. Ann Allergy Asthma Immunol 2009; 102:A34.

McCue S, Wilson D, Nelson V, Patel P, Salapatek AM: Validation of aerosolized cat dander in an environmental exposure chamber (EEC) clinical model. J Allergy Clin Immunol 2009; 123:S1- S232.

Lee J, Wilson D, Patel D, Bernstein J, D'Angelo P, Salapatek AM: The use of an environmental exposure chamber (EEC) model for challenging non-allergic rhinitis (NAR) patients to irritant triggers. Ann Allergy Asthma Immunol 2009; 103:A26.

Lee J, Wilson D, Patel D, Bernstein J, D'Angelo P, Salapatek AM: Objective and subjective response to simulated weather changes in non-allergic rhinitis (NAR) patients using a novel environmental exposure chamber (EEC) model. Ann Allergy Asthma Immunol 2009; 103:A25.

Lee J, Salapatek AM, Patel P, Soong F: Comparison of Non-Invasive Tear Break Up Times (NIBUT) Assessed With Video-Corneal Topography to the Standard Invasive TBUT as Studied in Patients After Exposure to Low Humidity Environment (LHE). Invest Ophthalmol Vis Sci 2009.

Lee J, Pozza L, Wilson D, Nelson V, Murdoch R, Tsitoura D, Barney B, Patel P, Salapatek AM: Validation of an Environmental Exposure Chamber (EEC) to Provide Controlled, Natural, Reproducible Exposures to Key Non-Allergic Environmental Triggers to Patients with Non- Allergic Rhinitis (NAR). Allergy 2009; 64:210.

Varghese S, Patel D, Patel P, Gopalan G, Yu X. Duration of Action of Mometasone Furoate Nasal Spray in Subjects with Symptoms of Seasonal Allergic Rhinitis Induced in an Environmental Exposure Chamber. J Allergy Clin Immunol 2008; 121:S54.

Salapatek AM, Patel P, Gopalan G, Varghese S: Objective measurement of nasal patency with acoustic rhinometry is a superior measure of nasal congestion than subjective symptom scoring and eliminates the placebo effect: evidence from a clinical trial of Mometasone Furoate nasal spray in patients with seasonal allergic rhinitis conducted in an environmental exposure chamber. Allergy 2008; 63:614.

Salapatek AM, Patel P, Gopalan G, Varghese S: Mometasone Furoate Nasal Spray Improves Congestion in Subjects With Seasonal Allergic Rhinitis as Measured Objectively With Acoustic Rhinometry. Allergy 2008; 63:87.

Salapatek AM, McCue S, Patel D, Patel P, Pipkin JD, Zimmerer RO: Quality of Life (QOL) in Ragweed Allergic Patients Treated with Captisol-Enabled® Budesonide Nasal Solution (32mcg/spray) when Exposed to Ragweed Pollen in an Environmental Exposure Chamber (EEC) Using an EEC-Specific Rhinoconjunctivitis Quality of Life Questionnaire (EEC-RQOLQ). The J Allergy Clin Immunol 2008; 121:S55.

Salapatek AM, McCue S, Nimraj L, Walsh V, Nandkeshore H, Chapman M, Corren J, Freihaut J, Patel P: Establishment of a Natural Cat Allergen Challenge Room (CACR) Using Aerosolized Milled Cat Dander. Ann Allergy Asthma Immunol 2008; 100:A43.

Salapatek AM, McCue S, Mansfield D, Eisfeld B, Benz M, Patel P, Pipkin J, Zimmerer R: Captisol- E labled Budesonide Nasal Spray Significantly Reduces Total Nasal (TNSS) and Non-Nasal Symptoms (TNNSS) Compared to Rhinocort Aqua and Placebo in Ragweed Allergic Patients in an Environmental Exposure Chamber (EEC) Model. Ann Allergy Asthma Immunol 2008; 100:A93.

Salapatek AM, Gopalan G, Varghese S, P P: Mometasone Reduces Congestion in Acoustic Rhinometry Study Otolaryngol Head Neck Surg 2008; 139:111.

Salapatek AM, Bates M, Patel P: A pilot environmental exposure chamber (EEC) study indicates rapid and prolonged relief of nasal symptoms after a single dose (110 μg) of fluticasone furoate nasal spray (FFNS) in patients with seasonal allergic rhinitis (SAR). Allergy 2008; 63:88.

Pozza LM, Barney B, Patel P, Salapatek AM: Development of a Non-Allergic Rhinitis Chamber (NARC) Model. J Allergy Clin Immunol 2008; 121:S233.

Pozza L, Wall M, Salapatek AM, Patel P: Seasonal Allergic Rhinitis studies conducted in an Environmental Exposure Chamber are highly reproducibile: three clinical studies of olopatadine nasal spray demonstrate an identical therapeutic response. Allergy 2008; 63:345.

Patel P, Patel D, Kunijibettu S, Hall N, Wingertzahn M. Onset and action of ciclesonide once daily in the treatment of seasonal allergic rhinitis. Ear Nose Throat J 2008; 86:340-53.

Patel P, Patel D, Edwards M, Drake M, Garadi R, Wells D, Potts S, Wall G. Onset of Action of Olopatadine Hydrochloride Nasal Spray 0.6% (Patanase®) in the Treatment of Allergic Rhinitis. J Allergy Clin Immunol 2008; 121:S50.

Patel P, Moisan R, Clark B, Cheng J, Desai J, Salapatek AM. Evaluation of an Emax Clinical Study Design to Test Clinical Equivalence of Inhaled Steroids (INS). Presented at the ATS Annual Meeting 2008.

Patel P. Efficacy and Long-term Safety of Mometasone Furoate Nasal Spray in Children 3-11 Years With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol 2008; 100:A90.

Patel D, Patel P. Levocetirizine is more effective than montelukast in improving symptoms of seasonal allergic rhinitis in subjects exposed to ragweed pollen in the Environmental Exposure Chamber. Ann Allergy Asthma Immunol 2008; 100:A86.

McCue S, Nimraj L, Walsh V, Nandkeshore H, Botezayas D, Chapman M, Corren J, Freihaut J, Patel P, Salapatek AM: Characterization of Aerosolized Fel d 1 in a Clinical Model During a One Hour Cat Allergen Challenge (CAC). Int Arch Allergy Immunol 2008.

McCue S, Walsh V, Chapman M, Freihaut J, Patel P, Salapatek AM: Assessment of total IgE, wheal response and Fel d 1 exposure as predictors of the asthmatic response in a natural cat allergen challenge room (CACR) clinical model. Allergy 2008; 63:288-289.

McCue S, Salapatek AM, Botetzayas D, Au Yeung C, Ducharme M, Patel P: Acoustic Rhinometry is an Effective Objective Measure for Nasal Congestion in Patients with Seasonal Allergic Rhinitis Exposed to Ragweed Pollen in an Environmental Exposure Chamber. Clin Pharmacol Ther 2008; 83:S72.

McCue S, Nimraj L, Walsh V, Nandkeshore H, Chapman M, Corren J, Freihaut J, Patel P, Salapatek AM: Establishing a Cat Allergen Challenge Room (CACR) Asthma Model. Presented at the ATS Annual Meeting 2008.

McCue S, Nimraj L, Walsh V, Nandkeshore H, Botezayas D, Chapman M, Corren J, Freihaut J, Patel P, Salapatek AM: Characterization of Aerosolized Fel d 1 in a Clinical Model During a One Hour Cat Allergen Challenge (CAC). J Allergy Clin Immunol 2008; 121:S178.

McCue S, Nimraj L, Walsh V, Chapman M, Freihaut J, Patel P, Salapatek AM: The cat allergen challenge room (CACR) is a successful clinical model in which cat allergic, moderately asthmatic patients respond safely to well-controlled Fel d 1 exposures. Allergy 2008; 63:576.

Freihaut J, Gomes C, Bahnfleth W, Salapatek AM, McCue S, Nimraj L, Walsh V, Patel P, Champan M: Mechanical and aerodynamic dispersion properties of indoor allergen carrier particles produced from natural materials. Allergy 2008; 63(S88)36.

Wilson D, Salapatek AM, Tanna P, Patel P: The Correlation between Allergen Skin Prick Test (SPT) Wheal Diameters and Nasal Symptoms to Aeroallergen Challenge in Environmental Exposure Chamber (EEC). The J Allergy Clin Immunol 2007; 119:S142.

Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on hypothalamic pituitary adrenal axis function by once daily fluticasone furoate nasal spray 110 mcg in adolescents and adults with perennial allergic rhinitis. J Allergy Clin Immunol 2007; 119(1): S231.

Wheeler W, Salapatek AM, Sacks H: Azelastine (Astelin®) Nasal Spray Improves Nasal Symptoms of Seasonal Allergic Rhinitis in 15 Minutes. Presented at the Intermountain West Allergy Association 2007:Presented at the Intermountain West Allergy Association.

Salapatek AM, Patel P, Shah C, Fischer von Weikersthal-Drachenberg K, Amersdorffer J: An Environmental Exposure Chamber (EEC)-Specific Rhinoconjunctivitis Quality of Life Questionnaire: The Symptoms of Seasonal Allergic Rhinitis Correlate with the Quality of Life (QOL) of Patients with Ragweed Allergy in the EEC. Ann Allergy Asthma Immunol 2007; 3:85.

Salapatek AM, Patel P, Mec N, Nimraj L, Ramoutar A, Chapman MD, Freihaut JD: Development of Asthma Study Technologies in an Environmental Chamber (ASTEC). J Allergy Clin Immunol 2007; 119:S3.

Salapatek AM, Patel P, Chan K, Talwar N, Drachenberg K, Amersdorffer J: An environmental exposure chamber specific rhinoconjunctivitis quality of life questionnaire: the symptoms of seasonal allergic rhinitis correlate with the quality of life of patients with ragweed allergy in the Environmental Exposure Chamber. Allergy 2007; 62:118.

Salapatek AM, McCue S, Sauve H, Tanna P, Patel P: Seasonal allergic rhinitis symptoms correlate with the quality of life in patients with ragweed allergy in the Environmental Exposure Chamber. World Allergy Organ J 2007; S74.

Salapatek AM, Freihaut J, Tanna P, Nimraj L, Ramoutar A, Sauve H, Chapman M, Patel P: Standardization of dust mite inhalant for use in an environmental exposure chamber. Ann Allergy Asthma Immunol 2007; 98(1):A107.

Patel P, Salapatek AM, Shah C, Tanna P, Kreiner E, Fischer von Weikersthal-Drachenberg K, Amersdorffer J: The Safety and Clinical Efficacy of Pollinex Quattro Ragweed Assessed in an Environmental Exposure Chamber (EEC). Ann Allergy Asthma Immunol 2007; 3:86.

Patel P, Salapatek AM, Shah C, Tanna P, Iyer D, Fischer von Weikersthal Drachenberg K, Amersdorffer J: Evaluation of the Safety and Immunogenicity of Pollinex Quattro Grass (PQ) in Patients Suffering from Grass and Rye Allergies. . Ann Allergy Asthma Immunol 2007; 3:85.

Patel P, Salapatek AM, Shah C, Tanna P, Chudak M, Fischer von Weikersthal Drachenberg K, Amersdorffer J: Assessment of the Residual Allergenicity of Pollinex Quattro Ragweed Using Skin-Prick Testing. . Ann Allergy Asthma Immunol 2007; 3:86.

Patel P, Salapatek AM, Shah C, McCue S, Fischer von Weikersthal-Drachenberg K, Amersdorffer J: Increased IgG Levels Induced by Pollinex Quattro Ragweed (PQ) in Ragweed-Allergic Patients Studied in an Environmental Exposure Chamber (EEC) Are Maintained during Follow-Up in the Natural Ragweed Pollen Season. Ann Allergy Asthma Immunol 2007; 3:87.

Patel P, Salapatek AM, Shah C, Chudak M, Jethwa K, Fischer vonWeikersthal-Drachenberg K, Amersdorffer J: Tree Pollen Allergoids in Pollinex Quattro Tree Immunotherapy Reduce the Residual Allergenicity as Assessed with Skin-Prick Tests (SPTs). Ann Allergy Asthma Immunol; 3:87.

Patel P, Salapatek AM, McCue S, Amersdorffer J, K. D: Increased IgG levels induced by ragweed MATA MPL in ragweed allergic patients studied in an environmental exposure chamber are maintained during follow-up in the natural ragweed pollen season. Allergy 2007; 62:233.

Patel P, Ratner P, Clements D, Wu W, Philpot E. Twenty-four serum and urine cortisol data support hypothalamic-pituitary adrenocortical axis safety of once-daily fluticasone furoate nasal spray 110mcg in adolescents and adults with perennial allergic rhinitis. Allergy 2007; 62:226.

Patel P, Andrea CD, Sacks H. Onset of Action of Azelastine Nasal Spray Compared to Mometasone Nasal Spray and Placebo in Patients with Seasonal Allergic Rhinitis (SAR). J Allergy Clin Immunol 2007; 119:S144.

McCue S, Nimraj L, Walsh V, Nandkeshore H, Chapman M, Corren J, Freihaut J, Patel P, Salapatek AM: Development of a natural cat allergen challenge room (CACR) model. World Allergy Organ J 2007; S37.

Freihaut J, Salapatek AM, Patel P, McCue S: Aerodynamic properties of milled allergen products: preparation of "standard", air suspendable dog, cat, cockroach and mite allergen powders. Allergy 2007; 62:38.

Chudak M, Patel P, Salapatek AM, Jethwa K, Weikersthal-Drachenberg KJFv, Amersdorffer J: Tree Pollen Allergoids in Pollinex Quattro Tree Immunotherapy Reduce the Residual Allergenicity as Assessed with Skin Prick Tests (SPTs). J Allergy Clin Immunol 2007; 119:S57.

Sauve H, Patel P, Talwar N. Development Plan for an Environmental Exposure Chamber (EEC) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in the EEC Setting. Presented at the EAACI Annual Meeting 2006.

Patel P, Nimraj L, Ramoutar A, Sauve H, Chapman M, Freihaut J, Salapatek AM: Development of a Environmental Exposure Chamber for the Study of Asthma using Milled Dust Mite Particles. Presented at the EAACI Annual Meeting 2006; 931.

Patel P, Benninger P, Cooper A, Moisan R, Thiessen JJ. Testing a Direct, Highly Sensitivity Method for Quantitation of Fluticasone Propionate in Human Plasma: Contrasting Nasal and Inhaled Exposure. J Allergy Clin Immunol 2006; 117:S190.

Mec M, Gosai P, Dubins D, Moisan R, Patel D, Patel P. Hypothermic Effect Observed Following Orally Administered Risperidone in Healthy Subjects. AAPS 2006 ;8.

Gosai P, Dubins D, Lui Y, Scott E, Raithatha N, Moisan R, Patel D, Patel P. Could Levothyroxine Sodium Be One of the Many Causes of 1st Degree Atrioventricular Block? AAPS 2006; 8.

Patel P, Rai K, Benninger PJ, Kaji Y, Margalias H, Moisan R. Effect of "Priming" on predose symptom scores in environmental exposure chamber (EEC) study design. J Allergy Clin Immunol 2005; 115:S239.

Patel P, Margalias H, Moisan R, Gow P, Wall M. Rhinitis Symptoms in an Environmental Exposure Chamber (EEC) Versus Traditional Seasonal Allergic Rhinitis (SAR) Trial. Presented at the EACCI Congress 2005.

Margalias H, Patel P, Hilmer M, Dubins D, Brubaker M, Wall M, et al. Peak Nasal Inspiratory Flow and Total Nasal Symptom Score for placebo nasal spray in an allergic rhinitis Environmental Exposure Chamber study. J Allergy Clin Immunol 2005; 115:S94.

Bibi T, Patel P, Dubins D, Brubaker M, Wall M, Drake M, et al. Less variability of symptom scores for placebo nasal spray in an environmental exposure chamber (EEC) study versus a traditional seasonal allergic rhinitis (SAR) study. J Allergy Clin Immunol 2005; 115:S239.

Patel P, Wall G, Benninger P, Margalias H, Brubaker M, Beezley S, et al. Dose Response, Duration and Onset of Action of Olopatadine Nasal Spray. Ann Allergy Asthma Immunol 2005; 94(1), 198.

Krueger JG, Ochs HD, Patel P, Gilkerson E, & Dummer W. Exploring effects on immune responses during and after immune modulation treatment with efalizumab in psoriasis patients. Presented at the ACAAI Annual Meeting 2004.

Patel P, Wall GM, Benninger P, Margalias H, Brubaker M, Beezley SF, Drake M, & Pott SL. Dose response, duration and onset of action of olopatadine nasal spray. Ann Allergy Asthma Immunol 2005; 94.1:198.

Cooper A, Benninger P, Patel P, Moisan R, Thiessen J. Developing an Unambiguous Validated Method for Clarithromycin and it's 14-(R)-Hydroxyclarithromycin Metabolite in Plasma Using LC/MS/MS. AAPS 2004; 6.

Benninger P, Moisan R, Liu Y, Dubins D, Patel D, Patel P, Thiessen J. Clinical Equivalence of topical nasal products: what will follow the FDA draft guidance? AAPS Meeting 2004.

Benninger P, Cooper A, Moisan R, Patel P, & Thiessen JJ. A comparative clarithromycin and 14- (R)- hydroxyclarithromycin under fasting and fed conditions. AAPS Meeting 2004.

Cooper A, Benninger P, Patel P, Moisan R, & Thiessen JJ. Developing an unambiguous validated method for clarithromycin and its 14-(R)- hydroxyclarithromycin metabolite in plasma using LC/MS/MS. AAPS Meeting 2004.

Thiessen J, Cory B, Stenlauf R, Benninger P, Moisan R, & Patel P. Comprehenstive bioequivalence evidence supporting interchangability of unithriod and synthroid. American Thyroid Association 2004.

Chapman KR, Patel P, Boulet LP, D'Urzo AD, Alexander M, Mehra S, et al. Efficacy and long-term safety of ciclesonide in asthmatic patients as demonstrated in a 52 week long study. J Eur Resp 2002; 20:373-374.

Meadwell L, Patel P, Benninger P, Lettieri J. A non-randomized study to evaluate the effect of hepatic impairment on the pharmacokinetics of faropenem daloxate. AAPS Meeting 2002.

Valadka R, Patel P, Lepage R, Moisan R, & Pari Respiratory Equipment Inc. Assessment of Intra and Inter Nebulizer Output Variablility Using The Pari LC Star Nebulizer. AAPS Meeting 2002.

Miller D, Patel P, et al. Safe and effective therapy with desloratadine for chronic idiopathic urticarial reduces interference with sleep and daily activities. AAD Meeting 2001.

Grimfeld A, Holgate ST, Adam D, Bonini S, Borres M, Canonica GW, Canseco Gonzalez C, Lobaton PM, Patel P, Szczeklik A, & Czarlewski W. Prevention du wheezing chez les nourrissons et jeunes enfants presentant des infections respiratories recidivantes traits par loratidine: resultants de l’etude Preventia. Presented at JPA Paris 2001.

Price D, Rouleau MY, Patel P, et al. Real world inhaled corticosteroid (ICS) tapering effect of montelukast in asthma over 48 weeks. ATS Meeting 2000.

Patel P & Alexander M. Efficacy and cost-effectiveness of 2% nedocromil sodium eye drops in comparison with fexofenadine in the treatment of seasonal allergic conjunctivitis. ARVO Meeting 2000.

Grimfeld A, Holgate ST, Adam D, Bonini S, Borres M, Canonica GW, Canseco G, Lobaton P, Patel P, Szczekik A, Danzig M, Harris A, Czarlewski. Loritadine (L) treatment reduces wheezing episodes in children at risk for recurrent upper respiratory infections (URI): Phase I results of Preventia study. Presented at the EAACI Congress 2000.

Gold M, Patel P, et al. Triamcinolone Nasal Spray vs loratadine tablets vs combination in patients with spring pollen allergic rhinoconjunctivitis. J Allergy Clin Immunol. 1996;97(1):432.

Patel P, et al. Levocabastine nasal spray and eye drops in the treatment of seasonal allergic rhinoconjunctivitis. AAAAI 1994.

Patel P, Prevost M, PetitClerc C, Danzig M. Combination of Loratadine Pseudo-ephedrine compared to actified in treatment of the common cold. EAACI 1994.

Roux M, Devillier P, Yang WH, Montagut A, Abiteboul K, Viatte A, Zeldin RK. Efficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber. J Allergy Clin Immunol 2016; 138(2):451-458.e5.

Murdoch RD , Bareille P , Denyer J , Newlands A , Bentley J , Smart K , Yarnall K , Patel D. TRPV1 inhibition does not prevent cold dry air-elicited symptoms in non-allergic rhinitis. Int J Clin Pharmacol Ther 2014; 52(4):267-276