Airway Responses to Montelukast and Desloratadine.

This study has been completed.

First Received on January 18, 2007. Last Updated on January 18, 2008 History of Changes

Sponsor:	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)

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:

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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

No publications provided by University of Saskatchewan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davis BE, Illamperuma C, Gauvreau GM, Watson RM, O'Byrne PM, Deschesnes F, Boulet LP, Cockcroft DW. Single-dose desloratadine and montelukast and allergen-induced late airway responses. Eur Respir J. 2009 Jun;33(6):1302-8. Epub 2009 Jan 22.

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:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Desloratadine
Loratadine
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012