NCT00140946

Brief Summary

A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
546

participants targeted

Target at P75+ for phase_4 asthma

Timeline
Completed

Started Mar 1998

Typical duration 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 1, 1998

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2000

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2.6 years

First QC Date

August 30, 2005

Last Update Submit

February 1, 2022

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Percentage of days of asthma exacerbations

Secondary Outcomes (3)

  • Percentage of asthma free days

  • Percentage of nocturnal awakenings

  • Beta agonist use

Interventions

MK0476; montelukast sodium/Duration of Treatment: 16 weeksDRUG
Comparator: placebo / Duration of Treatment: 16 weeksDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females between the ages of 18 and 70 with asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Vaquerizo MJ, Casan P, Castillo J, Perpina M, Sanchis J, Sobradillo V, Valencia A, Verea H, Viejo JL, Villasante C, Gonzalez-Esteban J, Picado C; CASIOPEA (Capacidad de Singulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group. Effect of montelukast added to inhaled budesonide on control of mild to moderate asthma. Thorax. 2003 Mar;58(3):204-10. doi: 10.1136/thorax.58.3.204.

    PMID: 12612294RESULT

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

March 1, 1998

Primary Completion

October 1, 2000

Study Completion

October 1, 2000

Last Updated

February 2, 2022

Record last verified: 2022-02