NCT00545324

Brief Summary

In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
399

participants targeted

Target at P75+ for phase_4 asthma

Timeline
Completed

Started Sep 2002

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

September 1, 2002

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
Last Updated

August 15, 2024

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

October 16, 2007

Last Update Submit

August 12, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Canadian asthma guidelines criteria

Secondary Outcomes (1)

  • Asthma control questionnaire

Interventions

MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 WeeksDRUG
Comparator: Fluticasone / Duration of Treatment: 6 WeeksDRUG

Eligibility Criteria

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

You may qualify if:

  • First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication
  • Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)
  • Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks
  • Patient's forced expiratory volume in one second (fev1) is \< 80% of predicted value

You may not qualify if:

  • Patient on combination therapy
  • Patient on long acting beta2 agonists
  • Patient on using moderate to high doses of ICS. (ICS \>250 \&micro g/day flovent\&reg; or equivalent per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

montelukastDuration of Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2007

First Posted

October 17, 2007

Study Start

September 1, 2002

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

August 15, 2024

Record last verified: 2022-01