Clinical trial

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

Name

0476-388

Description

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 arms

Trial start

2008-07-01

Estimated PCD

2008-12-01

Trial end

2008-12-01

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

1, 2, 3, 4

Other names:

SINGULAIR®, PROAIR® HFA

Comparator: placebo

Arms:

Size

Primary endpoint

Change From Baseline in FEV1 Over 4 Hours

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

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 68, 'type': 'ACTUAL'}}

Updated at

2024-05-09

1 organization

2 products

1 indication

Organization

Product

Indication

Product