Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Comparator: Placebo; Drug: Comparator: fluticasone; Drug: montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00284856

2005_108

0476-332

Details and patient eligibility

About

This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.

Enrollment: 1,640 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day

Exclusion criteria

• Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,640 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Arm 1: Montelukast

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Placebo

Drug: montelukast sodium

2

Active Comparator group

Description:

Arm 2: Fluticasone

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Placebo

Drug: Comparator: fluticasone

3

Placebo Comparator group

Description:

Arm 3: Placebo

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Placebo