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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma Bronchospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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T1

A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation

Group Type EXPERIMENTAL

albuterol inhalation powder

Intervention Type DRUG

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

T2

A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation

Group Type EXPERIMENTAL

albuterol inhalation powder

Intervention Type DRUG

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

T3

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

Group Type EXPERIMENTAL

albuterol inhalation powder

Intervention Type DRUG

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

T4

A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations

Group Type EXPERIMENTAL

albuterol inhalation powder

Intervention Type DRUG

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

P

Placebo, 2 inhalations

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo, lactose inhalation carrier

R1

Proventil 90 mcg/inhalation, 2 inhalations

Group Type ACTIVE_COMPARATOR

albuterol inhalation aerosol

Intervention Type DRUG

albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations

R2

Proventil 90 mcg/inhalation, 4 inhalations

Group Type ACTIVE_COMPARATOR

albuterol inhalation aerosol

Intervention Type DRUG

albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations

Interventions

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albuterol inhalation powder

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

Intervention Type DRUG

albuterol inhalation powder

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

Intervention Type DRUG

albuterol inhalation powder

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

Intervention Type DRUG

albuterol inhalation powder

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

Intervention Type DRUG

Placebo

placebo, lactose inhalation carrier

Intervention Type DRUG

albuterol inhalation aerosol

albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations

Intervention Type DRUG

albuterol inhalation aerosol

albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations

Intervention Type DRUG

Other Intervention Names

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Proventil Proventil

Eligibility Criteria

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Inclusion Criteria

* With mild-to-moderate persistent asthma for at least 6 months and having used inhaled beta-agonist for asthma control;
* Must demonstrate response to beta 2 agonist by Reversing;
* Must demonstrate ability to use DPI;
* Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
* Additional Criteria

Exclusion Criteria

* Smoking history of ≥ 10 pack-years, or having smoked within 6 months;
* Upper respiratory tract infections
* Asthma exacerbations;
* Known intolerance or hypersensitivity to any of the ingredients of the study drug or Proventil®;
* Use of prohibited drugs or failure to observe the drug washout restrictions;
* Having been on other clinical drug/device studies in the last 30 days;
* Other Criteria

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No