NCT00739297

Brief Summary

This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1

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

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 9, 2010

Completed
Last Updated

May 9, 2024

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

August 19, 2008

Results QC Date

January 14, 2010

Last Update Submit

May 7, 2024

Conditions

Chronic Asthma

Keywords

Chronic asthma

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in FEV1 Over 4 Hours

    FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.

    0 (=baseline) to 4 hours after treatment with montelukast

Secondary Outcomes (1)

  • Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration

    4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast

Other Outcomes (2)

  • Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast

    0 (baseline) and 8 hours after treatment with montelukast

  • Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast

    0 (baseline) and 24 hours after treatment with montelukast

Study Arms (4)

1

PLACEBO COMPARATOR

montelukast Placebo

Drug: Comparator: montelukastDrug: Comparator: placebo

2

EXPERIMENTAL

montelukast

Drug: Comparator: montelukast

3

EXPERIMENTAL

montelukast

Drug: Comparator: montelukast

4

EXPERIMENTAL

montelukast

Drug: Comparator: montelukast

Interventions

Comparator: montelukastDRUG

5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.

Also known as: SINGULAIR®, PROAIR® HFA
1234
Comparator: placeboDRUG

5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.

1

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A person is 15 to 65 years of age. A person has had chronic asthma for at least one year

You may not qualify if:

  • A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping
  • A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Philip G, Pedinoff A, Vandormael K, Tymofyeyev Y, Smugar SS, Reiss TF, Korenblat PE. A phase I randomized, placebo-controlled, dose-exploration study of single-dose inhaled montelukast in patients with chronic asthma. J Asthma. 2010 Dec;47(10):1078-84. doi: 10.3109/02770903.2010.520100. Epub 2010 Nov 3.

    PMID: 20936994DERIVED

MeSH Terms

Interventions

montelukast

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 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 9, 2024

Results First Posted

April 9, 2010

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share