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Sponsored by: |
IVAX Research LLC |
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Information provided by: | IVAX Research LLC |
ClinicalTrials.gov Identifier: | NCT00094016 |
The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in 1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal awakening and utilization of rescue medication per day also will be evaluated. In addition, an exploratory evaluation will assess the comparability of the two devices (i.e., QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.
Condition | Intervention | Phase |
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Asthma |
Drug: beclomethasone dipropionate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy Evaluation of Two Doses of HFA-Propelled Beclomethasone Dipropionate (QVAR) Versus Placebo by Breath Operated and Metered Dose Inhalers in Mild to Moderate Asthmatic Children |
Ages Eligible for Study: | 5 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients that have received any of the following treatments or met any of the following conditions within six weeks prior to the screening visit:
Study ID Numbers: | IXR-302-25-197 |
Study First Received: | October 8, 2004 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00094016 |
Health Authority: | United States: Food and Drug Administration |
Beclomethasone Asthma |
Anti-Inflammatory Agents Respiratory System Agents Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Hormones Glucocorticoids Pharmacologic Actions |