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

Lawson Health Research Institute

Status and phase

Completed

Phase 2

Conditions

Nasal Polyps

Treatments

Drug: Intranasal Beclomethasone spray

Drug: Intranasal Beclomethasone aerosol

Study type

Interventional

Funder types

Other

Identifiers

NCT00788463

R-06-542

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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