NCT00398151

Brief Summary

To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Aug 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

August 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
Last Updated

August 15, 2024

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

November 9, 2006

Last Update Submit

August 12, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy

Secondary Outcomes (1)

  • Asthma symptoms score throughout the study

Interventions

MK0476, montelukast sodium / Duration of Treatment: 12 WeeksDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
  • Male or female outpatient 20 years of age and older
  • Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test

You may not qualify if:

  • Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
  • Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
  • Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
  • Treated with montelukast within 3 months before enrollment
  • Unable to perform acceptable, reproducible spirometry and peak flow measurement
  • Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1

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

November 9, 2006

First Posted

November 10, 2006

Study Start

August 1, 2005

Primary Completion

January 18, 2006

Study Completion

January 18, 2006

Last Updated

August 15, 2024

Record last verified: 2022-01