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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00788463
First received: November 7, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Nasal Polyps
Drug: Intranasal Beclomethasone aerosol
Drug: Intranasal Beclomethasone spray
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire [ Time Frame: 0, 1, 3, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry [ Time Frame: 0, 1, 3, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerosol Drug: Intranasal Beclomethasone aerosol
Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.
Other Name: QVAR
Active Comparator: Spray Drug: Intranasal Beclomethasone spray
Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788463

Contacts
Contact: Jorge A Mazza, MD 519-685-8500 ext 58277 jmazza@uwo.ca

Locations
Canada, Ontario
Allergy Clinic, London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Jorge A Mazza, MD University of Western Ontario, Canada
  More Information

Publications:

Responsible Party: Jorge Mazza, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00788463     History of Changes
Other Study ID Numbers: R-06-542, 12801
Study First Received: November 7, 2008
Last Updated: November 7, 2008
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
administration, intranasal
aerosol
beclomethasone
QVAR
corticosteroids
nasal polyps
rhinomanometry
Rhinitis Quality of Life Questionnaire
Quality of Life

Additional relevant MeSH terms:
Nasal Polyps
Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014