Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma, Exercise-Induced

Treatments: Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (salmeterol); Drug: Comparator: Placebo (montelukast)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245570

0476-316

2005_043

MK0476-316

Details and patient eligibility

About

To determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.

Enrollment: 47 patients

Sex: All

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physician-diagnosed exercise-induced bronchospasm

Exclusion criteria

• Patient is, other than asthma, not in good, stable health. The Primary Investigator will evaluate whether there are other reasons why the patient may not participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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47 participants in 6 patient groups

1

Experimental group

Description:

Montelukast - Salmeterol - Placebo

Treatment:

Drug: Comparator: Salmeterol

Drug: Comparator: Placebo (salmeterol)

Drug: Comparator: Placebo (montelukast)

Drug: Comparator: Montelukast

2

Experimental group

Description:

Montelukast - Placebo - Salmeterol

Treatment:

Drug: Comparator: Salmeterol

Drug: Comparator: Placebo (salmeterol)

Drug: Comparator: Placebo (montelukast)

Drug: Comparator: Montelukast

3

Experimental group

Description:

Salmeterol - Montelukast - Placebo

Treatment:

Drug: Comparator: Salmeterol

Drug: Comparator: Placebo (salmeterol)

Drug: Comparator: Placebo (montelukast)

Drug: Comparator: Montelukast

4

Experimental group

Description:

Salmeterol - Placebo - Montelukast

Treatment:

Drug: Comparator: Salmeterol

Drug: Comparator: Placebo (salmeterol)

Drug: Comparator: Placebo (montelukast)

Drug: Comparator: Montelukast

5

Experimental group

Description:

Placebo - Montelukast - Salmeterol

Treatment:

Drug: Comparator: Salmeterol

Drug: Comparator: Placebo (salmeterol)

Drug: Comparator: Placebo (montelukast)

Drug: Comparator: Montelukast

6

Experimental group

Description:

Placebo - Salmeterol - Montelukast

Treatment:

Drug: Comparator: Salmeterol

Drug: Comparator: Placebo (salmeterol)

Drug: Comparator: Placebo (montelukast)

Drug: Comparator: Montelukast