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

Phase 2

Completed

Interventions: Drug: albuterol inhalation powder
Drug: albuterol inhalation aerosol
Drug: Placebo

Brief 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 & 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

Arm && Interventions

Group	Intervention	Description
T1	albuterol inhalation powder	A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation
T3	albuterol inhalation powder	A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
T2	albuterol inhalation powder	A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation
R1	albuterol inhalation aerosol	Proventil 90 mcg/inhalation, 2 inhalations
T4	albuterol inhalation powder	A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations
R2	albuterol inhalation aerosol	Proventil 90 mcg/inhalation, 4 inhalations
P	Placebo	Placebo, 2 inhalations

Primary Outcome Measures

Name	Time	Method
AUC	5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.	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.

Secondary Outcome Measures

Name	Time	Method
Time to Effect	0 to 360 minutes	Time to onset of bronchodilator effect
Hand Tremor	within 5 min. prior to dosing and 50 and 360 min post-dose.	Evaluation of hand tremor
Blood Work	within 15 min. prior to dosing, and 30 and 120 min. postdose	Collect blood samples (\~5 mL) for serum glucose and K+ tests
Response Rate	0 - 360 minutes	Bronchodilatory Response Rate
Vital Signs	within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.	Pulse, heartrate, respirations, blood pressure
Duration	0 - 360 minutes	Duration of effect
12 lead ECG	within 15 min. prior to dosing and at 50 and 360 min postdose.	12-lead ECG for routine and QT/QTc evaluations
Peak Response	0 - 360 minutes	peak bronchodilator response

Locations (4): Amphastar Site 0039
🇺🇸
Lakewood, Colorado, United States
Amphastar Site 0001
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San Jose, California, United States
Amphastar Site 0008
🇺🇸
Denver, Colorado, United States
Amphastar Site 0007
🇺🇸
Centennial, Colorado, United States