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

August 25, 2017 updated by: Lawson Health Research Institute
The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol or spray is more effective in treatment of nasal polyps.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Allergy Clinic, London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerosol
Drug: Intranasal Beclomethasone aerosol
Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.
Other Names:
  • QVAR
Active Comparator: Spray
Drug: Intranasal Beclomethasone spray
Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Jorge A Mazza, MD, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2006

Primary Completion (Actual)

March 30, 2009

Study Completion (Actual)

November 30, 2011

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-06-542

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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