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NCT01058863 · ClinicalTrials.gov registry record · Phase 2
A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma
A Phase 2 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 13
- Study locations
NCT01058863: Completed Phase 2 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01058863 is a Phase 2 study of Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 72 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01058863, a Phase 2 study of Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.
Primary Outcome
FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4,
Conditions Studied
Interventions
- DRUG Albuterol Spiromax®
- DRUG ProAir® HFA
- OTHER Placebo Inhaler
Study Locations (13)
California
- Teva Clinical Study Site - Huntington Beach
- Teva Clinical Study Site - Rolling Hills Est.
- Teva Clinical Study Site - San Diego
Florida
- Teva Clinical Study Site - Margate
- Teva Clinical Study Site - Miami
Ohio
- Teva Clinical Study Site - Cincinnati
- Teva Clinical Study Site - Dayton
Oregon
- Teva Clinical Study Site - Medford
- Teva Clinical Study Site - Portland
Colorado
- Teva Clinical Study Site - Colorado Springs
Missouri
- Teva Clinical Study Site - St Louis
New Jersey
- Teva Clinical Study Site - Skillman
North Carolina
- Teva Clinical Study Site - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT01058863 record still lists
NCT01058863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Albuterol Spiromax® is the first listed.
NCT01058863 lists 13 locations in 8 states (California, Florida, Ohio).
Frequently Asked Questions
What is clinical trial NCT01058863 about?
NCT01058863 is a clinical study titled "A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma". This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.
What is the current status of trial NCT01058863?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2010-02. Estimated completion is 2010-06.
What conditions does trial NCT01058863 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01058863?
The interventions under investigation include: Albuterol Spiromax® (DRUG), ProAir® HFA (DRUG), Placebo Inhaler (OTHER).
Who is sponsoring clinical trial NCT01058863?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01058863 being conducted?
This trial has 13 study locations across California, Colorado, Florida, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01058863's enrollment target sits among peer trials
72 237th of 374 higher than 136 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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