Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)

Summary

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.

Timeline

Start

2010-05

Primary completion

2010-10

Completion

2010-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); BDP HFA 320 µg/Day vs Placebo; p <0.001; LS Mean Difference -0.84 (95% CI -1.2 to -0.5) NCT01134705 ↗

paper Treatment with BDP nasal aerosol showed significantly greater improvement in average A.M. and P.M. rTNSS compared with placebo PMID 22737708 ↗

Publications

• Results Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK (2011). BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.
• Results Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. . BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol (Supplement); 107(11):A118 - Poster presentation.
• Results Carr W, Meltzer EO, Finn A, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. Effective nasal symptom relief and improvement in health-related quality of life in subjects with perennial allergic rhinitis following 6-week
• Meltzer EO, Korenblat PE, Lanier BQ, Kelley L, Tantry SK. Beclomethasone dipropionate nasal aerosol with an integrated dose counter: functionality and performance. Allergy Asthma Proc. 2013 Nov-Dec;34(6):534-41. doi: 10.2500/aap.2013.34.3707.
• Nayak AS, Atiee GJ, Dige E, Maloney J, Nolte H. Safety of ragweed sublingual allergy immunotherapy tablets in adults with allergic rhinoconjunctivitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):404-10. doi: 10.2500/aap.2012.33.3605.
• Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, Dunbar SA, Tantry SK. Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis. Allergy Asthma Proc. 2012 May-Jun;33(3):249-57. doi: 10.2500/aap.2012.33.3571.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	beclomethasone dipropionate	Other / unclassified	320 ug	Intranasal

Indications