Clinical trial NCT00788463: A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps
Official title: A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasal Polyps
Keywords: administration, intranasal
aerosol
beclomethasone
QVAR
corticosteroids
nasal polyps
rhinomanometry
Rhinitis Quality of Life Questionnaire
Quality of Life
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire
timeFrame: 0, 1, 3, 6 months
Secondary outcomes:
measure: Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry
timeFrame: 0, 1, 3, 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Allergy Clinic, London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Jorge A Mazza, MD
role: PRINCIPAL_INVESTIGATOR
References:
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