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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00788463

Enrollment

Registered

2008-11-11

Start date

2006-11-23

Completion date

2011-11-30

Last updated

2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Polyps

Keywords

administration, intranasal, aerosol, beclomethasone, QVAR, corticosteroids, nasal polyps, rhinomanometry, Rhinitis Quality of Life Questionnaire, Quality of Life

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.

Interventions

DRUGIntranasal Beclomethasone aerosol

Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.

DRUGIntranasal Beclomethasone spray

Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026