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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: Clinical Trial Phase 3 study, sponsored by Amphastar Pharmaceuticals.

NCT00634829 is a Phase 3 study that was terminated before completion, run by Amphastar Pharmaceuticals. The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 24 participants
Start Date 2008-02
Est. Completion 2008-10
Phase Phase 3
Amphastar Pharmaceuticals

21 total trials

Why NCT00634829 stopped before completion

NCT00634829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo-HFA is the first listed.

NCT00634829 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00634829's enrollment target sits among peer trials

24 1943rd of 2000 higher than 49 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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Source: ClinicalTrials.gov NCT00634829, the US trial registry maintained by the National Library of Medicine. NCT00634829 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.