Airway Responses to Montelukast and Desloratadine.

This study has been completed.
Sponsor:
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00424580
First received: January 18, 2007
Last updated: January 18, 2008
Last verified: January 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

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
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: 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

No publications provided by University of Saskatchewan

Additional 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
Study First Received: January 18, 2007
Last Updated: January 18, 2008
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 01, 2014