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

A

Amphastar Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Asthma

Bronchospasm

Treatments

Drug: albuterol inhalation aerosol

Drug: albuterol inhalation powder

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01174732

API-A006-CL-B

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

26 participants in 7 patient groups, including a placebo group

T1

Experimental group

Description:

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

Treatment:

Drug: albuterol inhalation powder

T2

Experimental group

Description:

A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation

Treatment:

Drug: albuterol inhalation powder

T3

Experimental group

Description:

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

Treatment:

Drug: albuterol inhalation powder

T4

Experimental group

Description:

A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations

Treatment:

Drug: albuterol inhalation powder

P

Placebo Comparator group

Description:

Placebo, 2 inhalations

Treatment:

Drug: Placebo

R1

Active Comparator group

Description:

Proventil 90 mcg/inhalation, 2 inhalations

Treatment:

Drug: albuterol inhalation aerosol

R2

Active Comparator group

Description:

Proventil 90 mcg/inhalation, 4 inhalations

Treatment:

Drug: albuterol inhalation aerosol

Trial contacts and locations

4

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