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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01218009
The ClinicalTrials.gov registry entry for NCT01218009 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 331 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 2 interventions - of which Albuterol Spiromax is the first listed.
NCT01218009 reports 0 study locations.
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.
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