CompletedPhase 3

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

47 participantsStarted 2005-12

Plain-language summary

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.

Who can participate

Age range15 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)

Timeframe: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose

Trial details

NCT IDNCT00245570

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-09

Results submitted2009-09-25

View on ClinicalTrials.gov More Asthma, Exercise-Induced trials