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| Sponsor: | Teva Branded Pharmaceutical Products, R&D Inc. |
|---|---|
| Information provided by (Responsible Party): | Teva Branded Pharmaceutical Products, R&D Inc. |
| ClinicalTrials.gov Identifier: | NCT00094016 |
Purpose
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 |
|---|---|---|
|
Asthma |
Drug: beclomethasone dipropionate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations
Show 39 Study Locations
More Information
| Responsible Party: | Teva Branded Pharmaceutical Products, R&D Inc. |
| ClinicalTrials.gov Identifier: | NCT00094016 History of Changes |
| Other Study ID Numbers: | IXR-302-25-197 |
| Study First Received: | October 8, 2004 |
| Last Updated: | August 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Beclomethasone |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |