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NCT01581177 · ClinicalTrials.gov registry record · Phase 2

Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation

A Phase 2 study, sponsored by Amphastar Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
23
Enrollment target

NCT01581177 is a Phase 2 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 23 participants.

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The verdict

NCT01581177, a Phase 2 study, has completed, sponsored by Amphastar Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control. This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.

Interventions

  • DRUG Placebo DPI
  • DRUG Albuterol DPI 25 mcg/inh
  • DRUG Albuterol DPI 90 mcg/inh
  • DRUG Albuterol MDI 90 mcg/inh

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2012-04
Est. Completion 2012-08
Phase Phase 2

Sponsor

Amphastar Pharmaceuticals

21 total trials

What the Registry Record Tells You About NCT01581177

The ClinicalTrials.gov registry entry for NCT01581177 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 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 4 interventions - of which Placebo DPI is the first listed.

NCT01581177 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01581177 about?

NCT01581177 is a clinical study titled "Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation". The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control. Thi...

What is the current status of trial NCT01581177?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2012-04. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01581177?

The interventions under investigation include: Placebo DPI (DRUG), Albuterol DPI 25 mcg/inh (DRUG), Albuterol DPI 90 mcg/inh (DRUG), Albuterol MDI 90 mcg/inh (DRUG).

Who is sponsoring clinical trial NCT01581177?

This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.