A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps
|Nasal Polyps||Drug: Intranasal Beclomethasone aerosol Drug: Intranasal Beclomethasone spray||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
|Official Title:||A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps|
- Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire [ Time Frame: 0, 1, 3, 6 months ]
- Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry [ Time Frame: 0, 1, 3, 6 months ]
|Actual Study Start Date:||November 23, 2006|
|Study Completion Date:||November 30, 2011|
|Primary Completion Date:||March 30, 2009 (Final data collection date for primary outcome measure)|
Drug: Intranasal Beclomethasone aerosol
Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.
Other Name: QVAR
|Active Comparator: Spray||
Drug: Intranasal Beclomethasone spray
Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.
Aqueous and aerosol delivery of intranasal corticosteroids has never been directly compared previously in patients with nasal polyps and it is unknown whether one is superior.
This objective of this study is to compare the efficacy of intranasal beclomethasone by two different delivery systems, aerosol and aqueous spray in patients with nasal polyps. Primary endpoint is the difference in the overall quality of life as measured by the Rhinitis Quality of Life Questionnaire. The secondary endpoint is the change in Nasal Airflow Resistance as measured by rhinomanometry.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788463
|Allergy Clinic, London Health Sciences Centre|
|London, Ontario, Canada, N6A 4G5|
|Principal Investigator:||Jorge A Mazza, MD||University of Western Ontario, Canada|