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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174732
• Other study ID #: API-A006-CL-B
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• Bronchial Spasm
• Bronchospasm

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