Clinical trial NCT01174732: Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
Official title: Phase II Study Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Cross-over and Dose-ranging Study of A006 DPI, Albuterol Inhalation Powder, in Adult Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Bronchospasm
Keywords: asthma
bronchospasm
COPD
chronic respiratory disease
Lead sponsor: Amphastar Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC
timeFrame: 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.
Secondary outcomes:
measure: Time to Effect
timeFrame: 0 to 360 minutes
measure: Peak Response
timeFrame: 0 - 360 minutes
measure: Duration
timeFrame: 0 - 360 minutes
measure: Response Rate
timeFrame: 0 - 360 minutes
measure: Hand Tremor
timeFrame: within 5 min. prior to dosing and 50 and 360 min post-dose.
measure: Vital Signs
timeFrame: within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.
measure: 12 lead ECG
timeFrame: within 15 min. prior to dosing and at 50 and 360 min postdose.
measure: Blood Work
timeFrame: within 15 min. prior to dosing, and 30 and 120 min. postdose
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Amphastar Site 0001
state: California
city: Centennial
country: United States
facility: Amphastar Site 0007
state: Colorado
city: Denver
country: United States
facility: Amphastar Site 0008
state: Colorado
city: Lakewood
country: United States
facility: Amphastar Site 0039
state: Colorado
Study officials:
affiliation: Amphastar Pharmaceuticals, Inc.
name: Safety Monitor
role: STUDY_DIRECTOR
References: