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Dose-Ranging Study of A006 DPI, in Adult Asthma Patients

NCT01174732 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-04-19

No results posted yet for this study

Summary

This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.

Conditions

Interventions

DRUG

albuterol inhalation powder

A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation

DRUG

albuterol inhalation powder

A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation

DRUG

albuterol inhalation powder

A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations

DRUG

albuterol inhalation powder

A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations

DRUG

Placebo

placebo, lactose inhalation carrier

DRUG

albuterol inhalation aerosol

albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations

DRUG

albuterol inhalation aerosol

albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations

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
2010-07-31
Primary Completion
2010-10-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01174732 on ClinicalTrials.gov