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NCT00634829 · ClinicalTrials.gov registry record · Phase 3
Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction
A Phase 3 study, sponsored by Amphastar Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT00634829 is a Phase 3 study that was terminated before completion, run by Amphastar Pharmaceuticals. The registered enrollment target is 24 participants.
The verdict
NCT00634829, a Phase 3 study, was terminated before completion, sponsored by Amphastar Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
This clinical study will evaluate and establish the protective effects of Amphastar's Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA), in preventing exercise-induced bronchoconstriction (EIB) in adolescent and adult asthmatic patients, in comparison with (1) Proventil®-HFA (Reference drug and Active Control ), and (2) Placebo-HFA control (HFA propellant only). Safety of the test drug, Albuterol-HFA, will also be evaluated in comparison to the Active and Placebo Controls. Analyses will be performed to determine if the Armstrong's Albuterol-HFA has resulted in a significant bronchoprotective effect, with attenuated Max % Fall in FEV1, in comparison to the Placebo-HFA control.
Interventions
- DRUG Placebo-HFA
- DRUG albuterol (Armstrong Albuterol HFA)
- DRUG Albuterol Sulfate (Provenetil-HFA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00634829
The ClinicalTrials.gov registry entry for NCT00634829 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amphastar Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo-HFA is the first listed.
NCT00634829 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00634829 about?
NCT00634829 is a clinical study titled "Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction". This clinical study will evaluate and establish the protective effects of Amphastar's Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA), in preventing exercise-induced bronchoconstriction (EIB) in adolescent and adult asthmatic patients, in comparison with (1) Proventil®-HFA (Reference drug a...
What is the current status of trial NCT00634829?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2008-02. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00634829?
The interventions under investigation include: Placebo-HFA (DRUG), albuterol (Armstrong Albuterol HFA) (DRUG), Albuterol Sulfate (Provenetil-HFA) (DRUG).
Who is sponsoring clinical trial NCT00634829?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
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