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Airway Responses to Montelukast and Desloratadine.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00424580
First Posted: January 19, 2007
Last Update Posted: January 23, 2008
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:
University of Saskatchewan
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Airway Responses to Montelukast and Desloratadine.

Resource links provided by NLM:


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

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:

  • 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
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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Donald W. Cockcroft, Department of Medicine, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00424580     History of Changes
Other Study ID Numbers: BIO-REB# 06-232
First Submitted: January 18, 2007
First Posted: January 19, 2007
Last Update Posted: January 23, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Montelukast
Desloratadine
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents