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

Primary Purpose

Asthma, Bronchospasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
albuterol inhalation powder
albuterol inhalation powder
albuterol inhalation powder
albuterol inhalation powder
Placebo
albuterol inhalation aerosol
albuterol inhalation aerosol
Sponsored by
Amphastar Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, bronchospasm, COPD, chronic respiratory disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Amphastar Site 0001
  • Amphastar Site 0007
  • Amphastar Site 0008
  • Amphastar Site 0039

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

T1

T2

T3

T4

P

R1

R2

Arm Description

A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation

A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation

A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations

A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations

Placebo, 2 inhalations

Proventil 90 mcg/inhalation, 2 inhalations

Proventil 90 mcg/inhalation, 4 inhalations

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Effect
Time to onset of bronchodilator effect
Peak Response
peak bronchodilator response
Duration
Duration of effect
Response Rate
Bronchodilatory Response Rate
Hand Tremor
Evaluation of hand tremor
Vital Signs
Pulse, heartrate, respirations, blood pressure
12 lead ECG
12-lead ECG for routine and QT/QTc evaluations
Blood Work
Collect blood samples (~5 mL) for serum glucose and K+ tests

Full Information

First Posted
July 29, 2010
Last Updated
April 17, 2017
Sponsor
Amphastar Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01174732
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amphastar Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchospasm
Keywords
asthma, bronchospasm, COPD, chronic respiratory disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T1
Arm Type
Experimental
Arm Description
A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation
Arm Title
T2
Arm Type
Experimental
Arm Description
A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation
Arm Title
T3
Arm Type
Experimental
Arm Description
A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
Arm Title
T4
Arm Type
Experimental
Arm Description
A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
Placebo, 2 inhalations
Arm Title
R1
Arm Type
Active Comparator
Arm Description
Proventil 90 mcg/inhalation, 2 inhalations
Arm Title
R2
Arm Type
Active Comparator
Arm Description
Proventil 90 mcg/inhalation, 4 inhalations
Intervention Type
Drug
Intervention Name(s)
albuterol inhalation powder
Intervention Description
A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation
Intervention Type
Drug
Intervention Name(s)
albuterol inhalation powder
Intervention Description
A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation
Intervention Type
Drug
Intervention Name(s)
albuterol inhalation powder
Intervention Description
A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
Intervention Type
Drug
Intervention Name(s)
albuterol inhalation powder
Intervention Description
A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo, lactose inhalation carrier
Intervention Type
Drug
Intervention Name(s)
albuterol inhalation aerosol
Other Intervention Name(s)
Proventil
Intervention Description
albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations
Intervention Type
Drug
Intervention Name(s)
albuterol inhalation aerosol
Other Intervention Name(s)
Proventil
Intervention Description
albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations
Primary Outcome Measure Information:
Title
AUC
Description
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.
Time Frame
5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.
Secondary Outcome Measure Information:
Title
Time to Effect
Description
Time to onset of bronchodilator effect
Time Frame
0 to 360 minutes
Title
Peak Response
Description
peak bronchodilator response
Time Frame
0 - 360 minutes
Title
Duration
Description
Duration of effect
Time Frame
0 - 360 minutes
Title
Response Rate
Description
Bronchodilatory Response Rate
Time Frame
0 - 360 minutes
Title
Hand Tremor
Description
Evaluation of hand tremor
Time Frame
within 5 min. prior to dosing and 50 and 360 min post-dose.
Title
Vital Signs
Description
Pulse, heartrate, respirations, blood pressure
Time Frame
within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.
Title
12 lead ECG
Description
12-lead ECG for routine and QT/QTc evaluations
Time Frame
within 15 min. prior to dosing and at 50 and 360 min postdose.
Title
Blood Work
Description
Collect blood samples (~5 mL) for serum glucose and K+ tests
Time Frame
within 15 min. prior to dosing, and 30 and 120 min. postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safety Monitor
Organizational Affiliation
Amphastar Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Amphastar Site 0001
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Amphastar Site 0007
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Amphastar Site 0008
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Amphastar Site 0039
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States

12. IPD Sharing Statement

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

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