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Airway Responses to Montelukast and Desloratadine.

This study has been completed.

Sponsored by: University of Saskatchewan
Information provided by: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00424580
  Purpose

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.


Condition Intervention
Asthma
Drug: Montelukast (10mg) and Desloratadine (5mg)

MedlinePlus related topics:   Asthma   

ChemIDplus related topics:   Montelukast    Montelukast sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:   Airway Responses to Montelukast and Desloratadine.

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Late asthmatic response (maximum percent decrease in FEV1)

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

Estimated Enrollment:   12
Study Start Date:   January 2007
Study Completion Date:   August 2007
Primary Completion Date:   August 2007 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424580

Locations
Canada, Saskatchewan
Room 346 Ellis Hall    
      Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators
University of Saskatchewan

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


Responsible Party:   Department of Medicine, University of Saskatchewan ( Dr. Donald W. Cockcroft )
Study ID Numbers:   BIO-REB# 06-232
First Received:   January 18, 2007
Last Updated:   January 18, 2008
ClinicalTrials.gov Identifier:   NCT00424580
Health Authority:   Canada: Health Canada

Study placed in the following topic categories:
Montelukast
Histamine phosphate
Asthma
Desloratadine
Histamine
Leukotriene Antagonists

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Histamine Agents
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Histamine Antagonists
Therapeutic Uses
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on October 03, 2008




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