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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: Clinical Trial Phase 3 study, sponsored by Amphastar Pharmaceuticals.
NCT00635505 is a Phase 3 study that was terminated before completion, run by Amphastar Pharmaceuticals. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00635505 stopped before completion
NCT00635505 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (61% lower).
The record links to 0 conditions, and to 3 interventions - of which albuterol HFA (Armstrong's) is the first listed.
NCT00635505 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00635505's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 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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