A proof-of-concept study of the effect of a novel H3-receptor antagonist in allergen- induced nasal congestion William T. Barchuk, MD, Anne Marie Salapatek,

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Presentation transcript:

A proof-of-concept study of the effect of a novel H3-receptor antagonist in allergen- induced nasal congestion William T. Barchuk, MD, Anne Marie Salapatek, PhD, Tingting Ge, PhD, Pina D'Angelo, MSc, Xuejun Liu, PhD Journal of Allergy and Clinical Immunology Volume 132, Issue 4, Pages 838-846.e6 (October 2013) DOI: 10.1016/j.jaci.2013.05.001 Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Participant accounting. Treatment A, 1 mL × 10 mg/mL JNJ-39220675 oral solution plus 1× placebo tablet; treatment B, 1 mL of placebo oral solution plus 1× 60-mg pseudoephedrine tablet; and treatment C, 1 mL of placebo oral solution plus 1× placebo tablet. aOther screen failures include patients who were withdrawn in error (n = 2), withdrawn from the study (n = 2), prohibited medication use (n = 1), lost to follow-up (n = 1), and unable to have blood drawn for assessments (n = 1). Participants randomized into the study should pass the EEC screening and must have had a decrease of 10% or greater in the MCA in either nostril, as assessed by using AcR before exposure (before entering the EEC) and after exposure (measured in the chamber) and must have a minimum TNSS of 6 of 12, including a score of at least 2 for congestion, on at least 1 diary card before dosing. Journal of Allergy and Clinical Immunology 2013 132, 838-846.e6DOI: (10.1016/j.jaci.2013.05.001) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 The mean changes from baseline in TNSSs and individual nasal symptom scores (intent-to-treat population) in the JNJ-39220675, pseudoephedrine, and placebo groups. Note: The severity of nasal symptoms (runny nose, itchy nose, nasal congestion, and sneezing) were recorded every 30 minutes while in the EEC on a 4-point scale (0, absent; 1, mild; 2, moderate; and 3, severe). A, TNSSs. B, Runny nose scores. C, Itchy nose scores. D, Nasal congestion scores. E, Sneezing scores. Journal of Allergy and Clinical Immunology 2013 132, 838-846.e6DOI: (10.1016/j.jaci.2013.05.001) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 The mean changes from baseline in TNSSs and individual nasal symptom scores (intent-to-treat population) in the JNJ-39220675, pseudoephedrine, and placebo groups. Note: The severity of nasal symptoms (runny nose, itchy nose, nasal congestion, and sneezing) were recorded every 30 minutes while in the EEC on a 4-point scale (0, absent; 1, mild; 2, moderate; and 3, severe). A, TNSSs. B, Runny nose scores. C, Itchy nose scores. D, Nasal congestion scores. E, Sneezing scores. Journal of Allergy and Clinical Immunology 2013 132, 838-846.e6DOI: (10.1016/j.jaci.2013.05.001) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Effect of EEC ragweed exposure on protein concentrations obtained from nasal lavage specimens of participants in the placebo group in period 1. Heat map of the log2 ratios of 13 proteins tested between post-EEC samples in period 1 and corresponding samples of prescreening EEC (baseline) from 12 patients of the placebo group. Each row represents 1 tested protein, and each column represents 1 patient. Red and blue indicate increases and decreases from baseline values, respectively. Hierarchic clustering on the proteins illustrates 2 major groups of proteins that exhibit distinctive expression patterns across patients. Journal of Allergy and Clinical Immunology 2013 132, 838-846.e6DOI: (10.1016/j.jaci.2013.05.001) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Study design. Journal of Allergy and Clinical Immunology 2013 132, 838-846.e6DOI: (10.1016/j.jaci.2013.05.001) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Cytokine and ECP levels in response to EEC ragweed exposure in the placebo group for each treatment period. A, IL-4. B, IL-5. C, IL-13. D, Human ECP. E, Albumin. Journal of Allergy and Clinical Immunology 2013 132, 838-846.e6DOI: (10.1016/j.jaci.2013.05.001) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E3 Effect of JNJ39220675 and pseudoephedrine on cytokine and ECP levels in response to EEC ragweed exposure during period 1. A, Treatment effect on IL-4. B, Treatment effect on IL-5. C, Treatment effect on IL-13. D, Treatment effect on human ECP. E, Treatment effect on albumin. Journal of Allergy and Clinical Immunology 2013 132, 838-846.e6DOI: (10.1016/j.jaci.2013.05.001) Copyright © 2013 American Academy of Allergy, Asthma & Immunology Terms and Conditions