Airway Responses to Montelukast and Desloratadine.

Asthma Clinical Trial

Official title:

Airway Responses to Montelukast and Desloratadine.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424580
• Other study ID #: BIO-REB# 06-232
• Status: Completed
• Phase: N/A
• First received: January 18, 2007
• Last updated: January 18, 2008
• Start date: January 2007
• Est. completion date: August 2007

Study information

• Verified date: January 2008
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Canada	Room 346 Ellis Hall	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late asthmatic response (maximum percent decrease in FEV1)
Secondary	Early asthmatic response (maximum percent decrease in FEV1
Secondary	Changes in sputum cell/mediator content
Secondary	Changes in airway hyperresponsiveness (methacholine PC20)