NCT00913328

Brief Summary

Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids. Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_4 asthma

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

August 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
Last Updated

June 4, 2009

Status Verified

June 1, 2009

Enrollment Period

3.8 years

First QC Date

June 3, 2009

Last Update Submit

June 3, 2009

Conditions

Asthma

Keywords

AsthmaAirway responsivenessDose-response plateauMontelukastAdd-on to inhaled corticosteroids

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in maximal FEV1 decline at the dose-response plateau

    After 12 weeks of treatment

Secondary Outcomes (1)

  • Changes from baseline in PD20 methacholine

    After 12 weeks of treatment

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

Oral montelukast 10 mg once daily for 12 weeks

Drug: Montelukast (Singulair)

Placebo

PLACEBO COMPARATOR

Oral placebo once daily for 12 weeks

Drug: Placebo

Interventions

Montelukast (Singulair)DRUG

10 mg tablet once daily

Also known as: Singulair
Montelukast
PlaceboDRUG

Oral placebo once daily

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoking adults with mild to moderate persistent asthma:
  • FEV1 \> 70 % pred
  • PD20 methacholine \< 3.9 mmol
  • treated for at least 3 months with a stable dose of inhaled corticosteroids
  • Documented dose-response plateau to inhaled methacholine on two occasions
  • Males and non-pregnant females

You may not qualify if:

  • Asthma medication other than inhaled corticosteroids and inhaled b2-agonists
  • Viral respiratory tract infections within the 3 weeks prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zuzana Diamant, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Charlotte S Ulrik, MD, DMSc

    Dept. of Heart and Lung Diseases, Hvidovre Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 4, 2009

Study Start

August 1, 2002

Primary Completion

May 1, 2006

Study Completion

October 1, 2006

Last Updated

June 4, 2009

Record last verified: 2009-06