NCT00424580

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 23, 2008

Status Verified

January 1, 2008

Enrollment Period

7 months

First QC Date

January 18, 2007

Last Update Submit

January 18, 2008

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Late asthmatic response (maximum percent decrease in FEV1)

Secondary Outcomes (3)

  • Early asthmatic response (maximum percent decrease in FEV1

  • Changes in sputum cell/mediator content

  • Changes in airway hyperresponsiveness (methacholine PC20)

Interventions

Montelukast (10mg) and Desloratadine (5mg)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • baseline FEV1 \> or = 65% predicted
  • positive methacholine challenge (i.e. methacholine PC20 \< or = 16mg/ml
  • positive allergen challenge

You may not qualify if:

  • negative skin prick test
  • lung condition/disease other than asthma
  • currently use montelukast and/or desloratadine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Room 346 Ellis Hall

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

  • 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. doi: 10.1183/09031936.00169008. Epub 2009 Jan 22.

    PMID: 19164343DERIVED

MeSH Terms

Conditions

Asthma

Interventions

montelukastdesloratadine

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Donald W Cockcroft, MD, FRCP(C)

    University of Saskatchew Full Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 19, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 23, 2008

Record last verified: 2008-01

Locations

CA(1)