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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01174732
Other study ID # API-A006-CL-B
Secondary ID
Status Completed
Phase Phase 2
First received July 29, 2010
Last updated April 17, 2017
Start date July 2010
Est. completion date January 2011

Study information

Verified date April 2017
Source Amphastar Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 2011
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
albuterol inhalation powder
A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation
albuterol inhalation powder
A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation
albuterol inhalation powder
A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
albuterol inhalation powder
A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations
Placebo
placebo, lactose inhalation carrier
albuterol inhalation aerosol
albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations
albuterol inhalation aerosol
albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations

Locations

Country Name City State
United States Amphastar Site 0007 Centennial Colorado
United States Amphastar Site 0008 Denver Colorado
United States Amphastar Site 0039 Lakewood Colorado
United States Amphastar Site 0001 San Jose California

Sponsors (1)

Lead Sponsor Collaborator
Amphastar Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUC Area under the curve (AUC) of post-dose FEV1 percentage changes from the Pre-dose Baseline. The primary analysis of the primary endpoint is to compare the AUC0-t of FEV1, between the A006 treatments and the Placebo Control. 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.
Secondary Time to Effect Time to onset of bronchodilator effect 0 to 360 minutes
Secondary Peak Response peak bronchodilator response 0 - 360 minutes
Secondary Duration Duration of effect 0 - 360 minutes
Secondary Response Rate Bronchodilatory Response Rate 0 - 360 minutes
Secondary Hand Tremor Evaluation of hand tremor within 5 min. prior to dosing and 50 and 360 min post-dose.
Secondary Vital Signs Pulse, heartrate, respirations, blood pressure within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.
Secondary 12 lead ECG 12-lead ECG for routine and QT/QTc evaluations within 15 min. prior to dosing and at 50 and 360 min postdose.
Secondary Blood Work Collect blood samples (~5 mL) for serum glucose and K+ tests within 15 min. prior to dosing, and 30 and 120 min. postdose
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