NCT00461032

Brief Summary

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,162

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Jun 2006

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

June 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 4, 2010

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

April 13, 2007

Results QC Date

January 12, 2010

Last Update Submit

January 31, 2022

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

    A day of worsening asthma is a day with: increase from baseline in β-agonist use (\> 70% and a min increase of 2 puffs); \> 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.

    8 Week treatment period initiated at the beginning of a school year

Secondary Outcomes (3)

  • Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)

    8 Week treatment period initiated at the beginning of a school year

  • Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

    8 Week treatment period initiated at the beginning of a school year

  • Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

    8 Week treatment period initiated at the beginning of a school year

Study Arms (2)

1

EXPERIMENTAL

montelukast

Drug: montelukast

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

montelukastDRUG

montelukast 5 mg tablet Once a day (QD) for 8 weeks

1
Comparator: PlaceboDRUG

Placebo to montelukast QD for 8 weeks

2

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

You may not qualify if:

  • Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Weiss KB, Gern JE, Johnston NW, Sears MR, Jones CA, Jia G, Watkins MW, Smugar SS, Edelman JM, Grant EN. The Back to School asthma study: the effect of montelukast on asthma burden when initiated prophylactically at the start of the school year. Ann Allergy Asthma Immunol. 2010 Aug;105(2):174-81. doi: 10.1016/j.anai.2010.04.018. Epub 2010 Jul 1.

    PMID: 20674830BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

April 13, 2007

First Posted

April 17, 2007

Study Start

June 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

February 2, 2022

Results First Posted

February 4, 2010

Record last verified: 2022-01