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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nasal Polyps

Intervention / Treatment
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* Drug: Intranasal Beclomethasone aerosol
* Drug: Intranasal Beclomethasone spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerosol<br> | Drug: Intranasal Beclomethasone aerosol<br>* Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.<br>* Other names: QVAR;|
| Active Comparator: Spray<br> | Drug: Intranasal Beclomethasone spray<br>* Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire |  | 0, 1, 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry |  | 0, 1, 3, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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administration, intranasal, aerosol, beclomethasone, QVAR, corticosteroids, nasal polyps, rhinomanometry, Rhinitis Quality of Life Questionnaire, Quality of Life