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NCT00094016 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
NCT00094016 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 440 participants.
The verdict
NCT00094016, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG beclomethasone dipropionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2004-10-31 |
| Est. Completion | 2006-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00094016
The ClinicalTrials.gov registry entry for NCT00094016 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which beclomethasone dipropionate is the first listed.
NCT00094016 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00094016 about?
NCT00094016 is a clinical study titled "Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children". 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 (pe...
What is the current status of trial NCT00094016?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2004-10-31. Estimated completion is 2006-06-30.
What interventions are being tested in trial NCT00094016?
The interventions under investigation include: beclomethasone dipropionate (DRUG).
Who is sponsoring clinical trial NCT00094016?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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