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

Chronic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739297
• Other study ID #: 0476-388
• Secondary ID: MK0476-3882008_5
• Status: Completed
• Phase: Phase 1
• Start date: July 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Chronic Asthma

Intervention

Drug:
• Comparator: montelukast
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.
• Comparator: placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast	Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.	0 (baseline) and 8 hours after treatment with montelukast
Other	Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast	Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.	0 (baseline) and 24 hours after treatment with montelukast
Primary	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	Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration	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.	4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast