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NCT01857323 · ClinicalTrials.gov registry record · Phase 3
Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)
A Phase 3 study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 317
- Enrollment target
- 20
- Study locations
NCT01857323 is a Phase 3 study of Asthma and Chronic Obstructive Pulmonary Disease (COPD) that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 317 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT01857323, a Phase 3 study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 317 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The purpose of this study is to evaluate the functionality, reliability, and accuracy of the Albuterol Spiromax inhaler integrated dose counter in a clinical setting.
Conditions Studied
Interventions
- DRUG Albuterol Spiromax®
Study Locations (20)
California
- Teva Investigational Site 10637 - Costa Mesa
- Teva Investigational Site 10635 - Huntington Beach
- Teva Investigational Site 10647 - Rolling Hills Estates
- Teva Investigational Site 10643 - San Diego
- Teva Investigational Site 10644 - San Jose
Colorado
- Teva Investigational Site 10622 - Centennial
- Teva Investigational Site 10634 - Denver
- Teva Investigational Site 10645 - Wheat Ridge
Florida
- Teva Investigational Site 10633 - Miami
- Teva Investigational Site 10640 - Ormond Beach
North Carolina
- Teva Investigational Site 10613 - High Point
- Teva Investigational Site 10616 - Raleigh
Arizona
- Teva Investigational Site 10620 - Phoenix
Kansas
- Teva Investigational Site 10641 - Overland Park
Maryland
- Teva Investigational Site 10636 - Bethesda
Massachusetts
- Teva Investigational Site 10631 - North Dartmouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01857323
The ClinicalTrials.gov registry entry for NCT01857323 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 317 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (80% lower). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Albuterol Spiromax® is the first listed.
NCT01857323 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01857323 about?
NCT01857323 is a clinical study titled "Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)". This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The purpose of this study is to evaluate the functionality, reliability, and accuracy of the Albuterol Spiromax inhaler i...
What is the current status of trial NCT01857323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 317 participants. The study started on 2013-05. Estimated completion is 2013-09.
What conditions does trial NCT01857323 study?
This clinical trial studies the following conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD).
What interventions are being tested in trial NCT01857323?
The interventions under investigation include: Albuterol Spiromax® (DRUG).
Who is sponsoring clinical trial NCT01857323?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01857323 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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