Skip to main content
OpenTrials
Completed

NCT Number: NCT00739297

The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Asthma

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Comparator: montelukast

Drug

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.

Other names: SINGULAIR®, PROAIR® HFA

Comparator: placebo

Drug

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.

Primary outcomes

  1. Change From Baseline in FEV1 Over 4 Hours

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

    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.

Secondary outcomes

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

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

    FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. 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.

Other outcomes

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

    Time frame: 0 (baseline) and 8 hours after treatment with montelukast

    Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.

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

    Time frame: 0 (baseline) and 24 hours after treatment with montelukast

    Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 21, 2008
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.