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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01174732

Enrollment

Registered

2010-08-04

Start date

2010-07-31

Completion date

2011-01-31

Last updated

2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchospasm

Keywords

asthma, bronchospasm, COPD, chronic respiratory disease

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.

Interventions

DRUGalbuterol inhalation powder

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

DRUGPlacebo

placebo, lactose inhalation carrier

DRUGalbuterol inhalation aerosol

albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Peak Response	0 - 360 minutes	peak bronchodilator response
Duration	0 - 360 minutes	Duration of effect
Response Rate	0 - 360 minutes	Bronchodilatory Response Rate
Time to Effect	0 to 360 minutes	Time to onset of bronchodilator effect
Vital Signs	within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.	Pulse, heartrate, respirations, blood pressure
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
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
Hand Tremor	within 5 min. prior to dosing and 50 and 360 min post-dose.	Evaluation of hand tremor

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026