Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma (NCT00085774) | Clinical Trial Compass
CompletedPhase 3
Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma
United States24 participantsStarted 2004-06-30
Plain-language summary
This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma.
Who can participate
Age range12 Years – 40 Years
SexALL
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Inclusion Criteria:
* Provide written informed consent
* Male or non-pregnant, non-nursing females aged 12 40 years, inclusive, at the first screening visit
* Have exercise-induced bronchospasm (EIB), with or without asthma, as demonstrated by a ≥15% decrease in pre-challenge absolute FEV1 observed up to 60 minutes following an exercise challenge conducted at the first screening visit
* Predicted FEV1 ≥70% for age, height, gender, and, where applicable, race following an 8 hour period without \[beta\]2 agonist use
* Have no contraindications for exercising maximally
* Ability to perform spirometry reproducibly (i.e., the difference between the two highest FEV1 values out of a minimum of three and a maximum of eight values obtained at the first screening visit must not exceed 0.2 L)
* Ability to self-perform PEF (peak expiratory flow) determinations with a handheld peak flow meter
* Can tolerate withdrawal of applicable medications for qualification at both screening visits
* Normal chest X ray, or, if abnormal, is consistent with asthma and shows no evidence of other active disease
* Otherwise healthy individuals with clinically acceptable medical history, physical examination, vital signs, and 12 lead ECG (electrocardiogram; with 30 second Lead II rhythm strip)
* Body mass index (BMI) of 19 29 kg/m2 (BMI = weight \[kg\] / height2 \[m\])
* Non-smokers for at least one year prior to the first screening visit and have maximum smoking histories of ten-pack years (i.e., equivale…
What they're measuring
1
The primary endpoint was mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge.
Timeframe: Three doses 2-7 days apart
Trial details
NCT IDNCT00085774
SponsorTeva Branded Pharmaceutical Products R&D, Inc.