NCT00445107

Brief Summary

The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_3 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

November 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
Last Updated

August 15, 2024

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

March 6, 2007

Last Update Submit

August 12, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change of the asthma control questionnaire scores taken over 8 weeks

Interventions

MK0476, montelukast sodium / Duration of Treatment: 8 WeeksDRUG

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year
  • Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis

You may not qualify if:

  • Patient has been treated in an emergency room for asthma within 4 weeks or has been hospitalized for asthma within 3 months prior to visit 1
  • Patient with severe asthma, upper respiratory infection, sinusitis, infectious rhinitis, non-allergic rhinitis
  • Patient has any active, acute, or chronic pulmonary disorder that is documented by history, physical examination

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 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 8, 2007

Study Start

November 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 17, 2006

Last Updated

August 15, 2024

Record last verified: 2022-01