A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps

Phase 2

Completed

• Conditions: Nasal Polyps
• Interventions: Drug: Intranasal Beclomethasone aerosol; Drug: Intranasal Beclomethasone spray

• Registration Number: NCT00788463
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol or spray is more effective in treatment of nasal polyps.

Detailed Description

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.

Study Timeline

• Study Start: 2006-11-23
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-11
• Primary Completion: 2009-03-30
• Study Completion: 2011-11-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 18 years old
• New diagnosis of nasal polyps confirmed by two physicians

Exclusion Criteria

• Intranasal corticosteroid use within 4 weeks
• Oral corticosteroids use within 4 weeks
• Oral corticosteroid inhalation (ie for treatment of asthma or COPD) of Budesonide >400ug daily, Fluticasone >250ug daily, Beclomethasone >400ug daily
• Contraindication to intranasal corticosteroid
• Inability to give informed consent
• Participation in another clinical trial
• Pregnancy (or not using effective method of contraception) or lactation
• Cystic fibrosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerosol	Intranasal Beclomethasone aerosol	-
Spray	Intranasal Beclomethasone spray	-

Primary Outcome Measures

Name	Time	Method
Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire	0, 1, 3, 6 months

Secondary Outcome Measures

Name	Time	Method
Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry	0, 1, 3, 6 months

Trial Locations

Locations (1)

Allergy Clinic, London Health Sciences Centre; 🇨🇦 London, Ontario, Canada