Chronic-dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics
| Status: | Completed |
|---|---|
| Conditions: | Asthma, Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 4 - 11 |
| Updated: | 4/21/2016 |
| Start Date: | July 2007 |
This study is designed to evaluate the repeat-dose safety and effectiveness of a
bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11
years with asthma. The dosing period lasts three weeks and starts following a three-week
run-in period.
bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11
years with asthma. The dosing period lasts three weeks and starts following a three-week
run-in period.
Inclusion Criteria:
- Persistent asthma of a minimum of six months duration that has been stable for at
least four weeks prior to screening
- Male and female children aged 4-11 years, inclusive, with predicted forced expiratory
volume in 1 second (FEV1) 60-90%
- Ability to perform spirometry
- Demonstrate 12% airways reversibility
Exclusion Criteria:
- Require continuous treatment with beta-blockers, monoamine oxidase inhibitors,
tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
- Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic
diseases
We found this trial at
14
sites
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