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NCT01218009 · ClinicalTrials.gov registry record · Phase 3
A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 3
- Development phase
- 331
- Enrollment target
NCT01218009: Clinical Trial Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01218009 is a Phase 3 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 331 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01218009, a Phase 3 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 331 participants
- Enrollment target
Study Summary
This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. Then for the last nine months of the study, all subjects will be given the albuterol dry powder inhaler and will use it only when needed to help with breathing problems. Subjects will need to keep a daily diary (both paper and electronic) throughout the study recording any inhaler use and health problems. There will be visits to the study doctor about once a month for a year. This study is intended to show that the albuterol dry powder inhaler works well and is safe for use over a long period of time.
Primary Outcome
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activitie
Interventions
- DRUG Albuterol Spiromax
- DRUG Placebo Spiromax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2010-10 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
Why NCT01218009 stopped before completion
NCT01218009 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Albuterol Spiromax is the first listed.
NCT01218009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01218009 about?
NCT01218009 is a clinical study titled "A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing". This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. Then for the last nine months of the study, all subjects will b...
What is the current status of trial NCT01218009?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2010-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01218009?
The interventions under investigation include: Albuterol Spiromax (DRUG), Placebo Spiromax (DRUG).
Who is sponsoring clinical trial NCT01218009?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01218009's enrollment target sits among peer trials
331 1066th of 2000 higher than 935 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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