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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01174732
First received: July 29, 2010
Last updated: January 23, 2012
Last verified: January 2012

July 29, 2010
January 23, 2012
July 2010
October 2010   (final data collection date for primary outcome measure)
AUC [ Time Frame: 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01174732 on ClinicalTrials.gov Archive Site
  • Time to Effect [ Time Frame: 0 to 360 minutes ] [ Designated as safety issue: No ]
    Time to onset of bronchodilator effect
  • Peak Response [ Time Frame: 0 - 360 minutes ] [ Designated as safety issue: No ]
    peak bronchodilator response
  • Duration [ Time Frame: 0 - 360 minutes ] [ Designated as safety issue: No ]
    Duration of effect
  • Response Rate [ Time Frame: 0 - 360 minutes ] [ Designated as safety issue: No ]
    Bronchodilatory Response Rate
  • Hand Tremor [ Time Frame: within 5 min. prior to dosing and 50 and 360 min post-dose. ] [ Designated as safety issue: Yes ]
    Evaluation of hand tremor
  • Vital Signs [ Time Frame: within 15 min. prior to dosing, and 30, 90 and 360 min post-dose. ] [ Designated as safety issue: Yes ]
    Pulse, heartrate, respirations, blood pressure
  • 12 lead ECG [ Time Frame: within 15 min. prior to dosing and at 50 and 360 min postdose. ] [ Designated as safety issue: Yes ]
    12-lead ECG for routine and QT/QTc evaluations
  • Blood Work [ Time Frame: within 15 min. prior to dosing, and 30 and 120 min. postdose ] [ Designated as safety issue: Yes ]
    Collect blood samples (~5 mL) for serum glucose and K+ tests
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Asthma
  • Bronchospasm
  • Drug: albuterol inhalation powder
    A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation
  • Drug: albuterol inhalation powder
    A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation
  • Drug: albuterol inhalation powder
    A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
  • Drug: albuterol inhalation powder
    A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations
  • Drug: Placebo
    placebo, lactose inhalation carrier
  • Drug: albuterol inhalation aerosol
    albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations
    Other Name: Proventil
  • Drug: albuterol inhalation aerosol
    albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations
    Other Name: Proventil
  • Experimental: T1
    A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation
    Intervention: Drug: albuterol inhalation powder
  • Experimental: T2
    A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation
    Intervention: Drug: albuterol inhalation powder
  • Experimental: T3
    A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
    Intervention: Drug: albuterol inhalation powder
  • Experimental: T4
    A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations
    Intervention: Drug: albuterol inhalation powder
  • Placebo Comparator: P
    Placebo, 2 inhalations
    Intervention: Drug: Placebo
  • Active Comparator: R1
    Proventil 90 mcg/inhalation, 2 inhalations
    Intervention: Drug: albuterol inhalation aerosol
  • Active Comparator: R2
    Proventil 90 mcg/inhalation, 4 inhalations
    Intervention: Drug: albuterol inhalation aerosol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
January 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01174732
API-A006-CL-B
No
Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Director Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP