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NCT00635505 · ClinicalTrials.gov registry record · Phase 3
Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients
A Phase 3 study, sponsored by Amphastar Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT00635505 is a Phase 3 study that was terminated before completion, run by Amphastar Pharmaceuticals. The registered enrollment target is 300 participants.
The verdict
NCT00635505, a Phase 3 study, was terminated before completion, sponsored by Amphastar Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with: 1. Placebo control: (HFA propellant only, Treatment P); and 2. Active control: 3M/Key's Proventil-HFA (Treatment R). The treatments will be given as self-administered oral inhalations in adult and adolescent patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week study is two actuations four times daily (QID).
Interventions
- DRUG albuterol HFA (Armstrong's)
- DRUG albuterol HFA (Proventil HFA)
- DRUG HFA placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00635505
The ClinicalTrials.gov registry entry for NCT00635505 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 300 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 albuterol HFA (Armstrong's) is the first listed.
NCT00635505 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00635505 about?
NCT00635505 is a clinical study titled "Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients". This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with: 1. Placebo control: (HFA propellant only, Treatment...
What is the current status of trial NCT00635505?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2007-09. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00635505?
The interventions under investigation include: albuterol HFA (Armstrong's) (DRUG), albuterol HFA (Proventil HFA) (DRUG), HFA placebo (DRUG).
Who is sponsoring clinical trial NCT00635505?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
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