NCT00380705

Brief Summary

Allow physicians not familiar with anti-leukotriene based therapy to test it

Trial Health

100
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Mar 2005

Shorter than P25 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

March 18, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
Last Updated

August 15, 2024

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

September 22, 2006

Last Update Submit

August 12, 2024

Conditions

AsthmaRhinitis Allergic

Outcome Measures

Primary Outcomes (1)

  • Quality of life measures

Secondary Outcomes (1)

  • Nocturnal wake up, work or school absences, physical activity and recurrence of asthma and/or rhinitis

Interventions

MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 WeeksDRUG

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment
  • Voluntary acceptance to participate in the study

You may not qualify if:

  • Patients with cystic fibrosis
  • Patients with known hypersensitivity to singulair or any of its components
  • Patients with severe chronic asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaRhinitis, Allergic, Perennial

Interventions

montelukastDuration of Therapy

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitis, AllergicRhinitisNose DiseasesOtorhinolaryngologic 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 26, 2006

Study Start

March 18, 2005

Primary Completion

July 29, 2005

Study Completion

July 29, 2005

Last Updated

August 15, 2024

Record last verified: 2022-01