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

NCT01581177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-05-19

No results posted yet for this 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.

Conditions

Interventions

DRUG

Albuterol DPI 25 mcg/inh

Albuterol DPI with 25 mcg Albuterol/inhalation

DRUG

Albuterol DPI 90 mcg/inh

Albuterol DPI with 90 mcg Albuterol/inhalation

DRUG

Placebo DPI

Placebo DPI with 0 mcg Albuterol/inhalation

DRUG

Albuterol MDI 90 mcg/inh

Albuterol MDI with 90 mcg Albtuerol/inhalation

Sponsors & Collaborators

  • Amphastar Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Safety Monitor · Amphastar Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01581177 on ClinicalTrials.gov