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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788463
First Posted: November 11, 2008
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawson Health Research Institute
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]

Secondary Outcome Measures:
  • Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry [ Time Frame: 0, 1, 3, 6 months ]

Enrollment: 30
Actual Study Start Date: November 23, 2006
Study Completion Date: November 30, 2011
Primary Completion Date: March 30, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788463


Locations
Canada, Ontario
Allergy Clinic, London Health Sciences Centre
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: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00788463     History of Changes
Other Study ID Numbers: R-06-542
First Submitted: November 7, 2008
First Posted: November 11, 2008
Last Update Posted: August 28, 2017
Last Verified: August 2017

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:
Polyps
Nasal Polyps
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents