Petasol butenoate complex (Ze 339) relieves allergic rhinitis–induced nasal obstruction more effectively than desloratadine Alina F. Dumitru, MD, Mohamed.

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Presentation transcript:

Petasol butenoate complex (Ze 339) relieves allergic rhinitis–induced nasal obstruction more effectively than desloratadine Alina F. Dumitru, MD, Mohamed Shamji, PhD, Martin Wagenmann, MD, Simone Hindersin, MD, Kathrin Scheckenbach, MD, Jens Greve, MD, Thomas Klenzner, MD, Lorenzo Hess, MSc, Sabine Nebel, PhD, Christian Zimmermann, PhD, Catherine Zahner, PhD, Carsten B. Schmidt-Weber, PhD, Adam M. Chaker, MD Journal of Allergy and Clinical Immunology Volume 127, Issue 6, Pages 1515-1521.e6 (June 2011) DOI: 10.1016/j.jaci.2011.02.045 Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Study design. Ze 339, desloratadine, and placebo were applied in a randomized 3-way crossover design. Medication was taken for 5 days, and allergen challenge was performed on the fifth day of treatment. Journal of Allergy and Clinical Immunology 2011 127, 1515-1521.e6DOI: (10.1016/j.jaci.2011.02.045) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Determination of nasal flow by means of anterior rhinomanometry after baseline measurement at time point 0 and nasal allergen challenge. A, Median nasal air flow over time (relative change from baseline). B, AOC 3 hours after nasal allergen challenge (means ± SEMs). C, AOC 24 hours after nasal allergen challenge (means ± SEMs). Significance was reached for the reduction in AOC at 0 to 24 hours for Ze 339 compared with placebo (mean ± SEM: 316.8 ± 88.5 vs 555.0 ± 128.8; P = .012, Wilcoxon signed-rank test). Journal of Allergy and Clinical Immunology 2011 127, 1515-1521.e6DOI: (10.1016/j.jaci.2011.02.045) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Recovery of nasal obstruction. A, Cox regression model of the time to return to 90% of nasal air flow after nasal allergen challenge assessed by means of rhinomanometry (Ze 339, 2.46 hours; desloratadine, 3.94 hours [medians], P = .046). B, Time to return to 90% of basal flow (means ± SEMs assessed by means of rhinomanometry: Ze 339, 5.4 ± 1.6 hours; placebo, 9.1 ± 2.3 hours; desloratadine, 10.7 ± 2.5 hours; Wilcoxon signed-rank test). C, Time to RTB value of the symptom of nasal obstruction (means ± SEMs assessed by means of VAS: Ze 339, 3.2 ± 1.3 hours; placebo, 8.3 ± 2.4 hours; desloratadine, 4.5 ± 1.2 hours; Wilcoxon signed-rank test). Journal of Allergy and Clinical Immunology 2011 127, 1515-1521.e6DOI: (10.1016/j.jaci.2011.02.045) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 4 Concentrations in picograms per milliliter per milligram of nasal secretion) of IL-8 (A) and LTB4 (B) in nasal secretions. Individual values of all patients (n = 18) are displayed as data points, and mean levels are indicated as bars. Levels were determined on the fifth day of the treatment before allergen challenge. IL-8: Ze 339, 8.5 ± 1.7 pg/mL; placebo, 52.9 ± 18.9 pg/mL; desloratadine, 50.1 ± 20.3 pg/mL. LTB4: Ze 339, 9.3 ± 3.7 pg/mL; placebo, 57.5 ± 26.8 pg/mL; desloratadine, 44.6 ± 14.0 pg/mL. P values were determined by using the paired t test. Journal of Allergy and Clinical Immunology 2011 127, 1515-1521.e6DOI: (10.1016/j.jaci.2011.02.045) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 AOCs and AUCs are interconvertible and are calculated in most of the cases by using the linear trapezoidal rule. Journal of Allergy and Clinical Immunology 2011 127, 1515-1521.e6DOI: (10.1016/j.jaci.2011.02.045) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Sneeze symptoms (A) and nasal obstruction (B) displayed as the difference from baseline values (means assessed as VAS scores). Journal of Allergy and Clinical Immunology 2011 127, 1515-1521.e6DOI: (10.1016/j.jaci.2011.02.045) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E3 Median concentration (pg/mL) of nasal mediators (A, IL-8; B, LTB4; C, histamine; and D, PGD2) over 24 hours on allergen challenge (red, Ze 339; blue, desloratadine; black, placebo) and the AUC after 3 and 24 hours (pg/mL * hours) displayed as scatter plots and medians. Significance was reached for the AUC of PGD2 in the early phase after nasal allergen challenge (mean ± SEM) during treatment with Ze 339 in comparison with desloratadine (979.1 ± 149.8 vs 1421 ± 164.1; P = .0077, paired t test) and for the AUC of histamine in the late-phase response (mean ± SEM) in both treatment groups in comparison with placebo (Ze 339 vs placebo: 464.9 ± 115.5 vs 272.3 ± 67.4 [P = .0361]; desloratadine vs placebo: 513.7 ± 128.5 vs 272.3 ± 67.4 [P = .0398, paired t test]). Journal of Allergy and Clinical Immunology 2011 127, 1515-1521.e6DOI: (10.1016/j.jaci.2011.02.045) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions