Airway Responses to Montelukast and Desloratadine.

Montelukast (for asthma) and desloratadine (for allergies) are effective therapy for their current uses. Part of what happens when your allergies trigger your asthma should be prevented by either of these drugs. This project is being conducted to determine if these drugs are effective, either alone or in combination, on controlling asthma that is triggered by allergies...

Date First Received: January 18, 2007

Last Updated: January 18, 2008

Verified by: University of Saskatchewan, January 2008

Clinical Trial Phase: N/A | Start Date: January 2007

Overall Status: Completed

Estimated Enrollment: 12

Brief Summary

Official Title: “Airway Responses to Montelukast and Desloratadine.”

Condition Keyword(s):

Montelukast (for asthma) and desloratadine (for allergies) are effective therapy for their current uses. Part of what happens when your allergies trigger your asthma should be prevented by either of these drugs. This project is being conducted to determine if these drugs are effective, either alone or in combination, on controlling asthma that is triggered by allergies.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: August 2007

Intervention(s) in this Clinical Trial

  • Drug: Montelukast (10mg) and Desloratadine (5mg)

Outcome Measures for this Clinical Trial

Primary Measures

  • Late asthmatic response (maximum percent decrease in FEV1)

Secondary Measures

  • Early asthmatic response (maximum percent decrease in FEV1
  • Changes in sputum cell/mediator content
  • Changes in airway hyperresponsiveness (methacholine PC20)

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • baseline FEV1 > or = 65% predicted
  • positive methacholine challenge (i.e. methacholine PC20 < or = 16mg/ml
  • positive allergen challenge

Exclusion Criteria:

  • negative skin prick test
  • lung condition/disease other than asthma
  • currently use montelukast and/or desloratadine

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: University of Saskatchewan

Overall Clinical Trial Officials and Contacts

Donald W Cockcroft, MD, FRCP(C) Principal Investigator University of Saskatchew Full Professor  

Additional Information

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00424580

Study ID Number: BIO-REB# 06-232

ClinicalTrials.gov Identifier: NCT00424580

Health Authority: Canada: Health Canada

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