Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma, Exercise-Induced

Treatments: Drug: Comparator: Placebo; Drug: Comparator: Montelukast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090142

0476-275

2004_009

Details and patient eligibility

About

The purpose of this study is 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: 62 patients

Sex: All

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with mild-to-moderate asthma

Exclusion criteria

• Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
• 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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62 participants in 2 patient groups

1

Experimental group

Description:

Montelukast - Placebo

Treatment:

Drug: Comparator: Montelukast

Drug: Comparator: Placebo

2

Experimental group

Description:

Placebo - Montelukast

Treatment:

Drug: Comparator: Montelukast

Drug: Comparator: Placebo