NCT00117338

Brief Summary

This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Jul 2005

Typical duration 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

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 11, 2009

Completed
Last Updated

May 10, 2024

Status Verified

January 1, 2022

Enrollment Period

2.7 years

First QC Date

June 30, 2005

Results QC Date

March 16, 2009

Last Update Submit

May 7, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration

    Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.

    Baseline and (time weighted average over) 60 Minutes

Secondary Outcomes (6)

  • Change From Baseline in Modified Pulmonary Index [mPI] Score

    Baseline and 60 minutes

  • Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)

    120 minutes

  • Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration

    Baseline and (time-weighed average over) 45 Minutes

  • Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration

    Baseline and (time-weighted average over) 30 Minutes

  • Change in FEV1 After 15 Minutes Following the End of Study Drug Administration

    Baseline and 15 Minutes

  • +1 more secondary outcomes

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Comparator: placebo (unspecified)

2

ACTIVE COMPARATOR

montelukast sodium

Drug: montelukast sodium

Interventions

montelukast sodiumDRUG

Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration

Also known as: MK0476, SINGULAIR®
2
Comparator: placebo (unspecified)DRUG

Pbo for a study approximately 120 minutes in duration

1

Eligibility Criteria

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

You may qualify if:

  • Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

You may not qualify if:

  • Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Morris CR, Becker AB, Pinieiro A, Massaad R, Green SA, Smugar SS, Gurner DM. A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma. Ann Allergy Asthma Immunol. 2010 Feb;104(2):161-71. doi: 10.1016/j.anai.2009.11.065.

    PMID: 20306820DERIVED

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

June 30, 2005

First Posted

July 6, 2005

Study Start

July 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 10, 2024

Results First Posted

August 11, 2009

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share