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

Organon

Status and phase: Completed; Phase 1

Conditions: Chronic Asthma

Treatments: Drug: Comparator: placebo; Drug: Comparator: montelukast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739297

2008_542

MK0476-388

0476-388

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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68 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

montelukast Placebo

Treatment:

Drug: Comparator: montelukast

Drug: Comparator: placebo

2

Experimental group

Description:

montelukast

Treatment:

Drug: Comparator: montelukast

3

Experimental group

Description:

montelukast

Treatment:

Drug: Comparator: montelukast

4

Experimental group

Description:

montelukast

Treatment:

Drug: Comparator: montelukast