Skip to main content
OpenTrials
Completed

NCT Number: NCT00788463

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allergy Clinic, London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal Beclomethasone aerosol

Drug

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

Other names: QVAR

Intranasal Beclomethasone spray

Drug

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

Primary outcomes

  1. Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire

    Time frame: 0, 1, 3, 6 months

Secondary outcomes

  1. Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry

    Time frame: 0, 1, 3, 6 months

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2011
First posted
Nov 11, 2008
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.