NCT00092144

Brief Summary

The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Feb 2004

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

February 26, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2004

Completed
Last Updated

August 15, 2024

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

September 21, 2004

Last Update Submit

August 12, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period

Secondary Outcomes (7)

  • To assess the following over a 3-week treatment period:

  • nighttime symptoms

  • AM PEFR

  • PM PEFR

  • B-agonist use

  • +2 more secondary outcomes

Interventions

MK0476, montelukast sodium / Duration of Treatment: 4 weeksDRUG
Comparator: placebo / Duration of Treatment: 4 weeksDRUG

Eligibility Criteria

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

You may qualify if:

  • Asthma symptoms brought on by allergies

You may not qualify if:

  • Patient has any lung disease
  • Currently have a sinus infection or cold symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Busse WW, Casale TB, Dykewicz MS, Meltzer EO, Bird SR, Hustad CM, Grant E, Zeldin RK, Edelman JM. Efficacy of montelukast during the allergy season in patients with chronic asthma and seasonal aeroallergen sensitivity. Ann Allergy Asthma Immunol. 2006 Jan;96(1):60-8. doi: 10.1016/S1081-1206(10)61041-1.

    PMID: 16440534BACKGROUND

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

Study Record Dates

First Submitted

September 21, 2004

First Posted

September 24, 2004

Study Start

February 26, 2004

Primary Completion

June 15, 2004

Study Completion

June 15, 2004

Last Updated

August 15, 2024

Record last verified: 2022-01