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Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581177
First Posted: April 20, 2012
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc.
April 17, 2012
April 20, 2012
May 19, 2017
April 2012
July 2012   (Final data collection date for primary outcome measure)
Change in FEV1 Area Under the Curve (AUC) versus placebo [ Time Frame: Visits 1-7, at baseline, 5, 20, 30, 60, 90, 120, 240, 360 minutes post-dose ]
Serial FEV1 measurements to demonstrate the mean AUC change in percent FEV1 from same-day baseline of A006 versus placebo control
Same as current
Complete list of historical versions of study NCT01581177 on ClinicalTrials.gov Archive Site
  • Placebo AUC of adjusted FEV1 changes [ Time Frame: Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose ]
    Determination of change of FEV1 in placebo arm
  • AUC of post-dose FEV1 volume changes from pre-dose baseline to Visit 7 [ Time Frame: Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose ]
    Determination of FEV1 volume change from pre-dose baseline to post treatment at Visit 7
  • Time post-dose change in FEV1 percent first reaches greater than or equal to 12 percent over the Pre-dose Baseline [ Time Frame: Visits 1-7, at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose ]
    Time to onset of bronchodilator effect (Tonset), determined by linear interpolation as the point where post-dose change in FEV1 percent first reaches greater than or equal to 12 percent over the Pre-dose Baseline.
  • Peak bronchodilator response (Fmax) [ Time Frame: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose ]
    The peak bronchodilator response (Fmax), defined as the maximum post-dose change in FEV1 percent.
  • Time to peak FEV1 effect (tmax) [ Time Frame: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose ]
    The time to peak FEV1 effect (tmax), defined as the time of Fmax.
  • Duration of effect [ Time Frame: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180 and 360 minutes post-dose ]
    Duration of effect, calculated as the total duration of bronchodilator effects when change in FEV1 percent is greater than or equal to 12 percent above baseline.
  • Bronchodilatory Response Rate (R percent) [ Time Frame: Visits 1-7 at 60 minutes ]
    Evaluation of Bronchodilatory Response Rate (R percent) of responders who demonstrate a greater than or equal to 12 percent increase for change in FEV1 percent during the initial 60 min post-dose.
  • Dose response curve: AUC of change in percent FEV1 versus Dose [ Time Frame: Visits 1-7 ]
    Evaluation of change in FEV1 in relation to dose.
  • Vital Signs (i.e.: blood pressure and heart rate) [ Time Frame: Visits 1-7 and EOS at baseline, 3, 8, 15, 30, 90 and 360 minutes post-dose ]
    Vital signs, i.e. blood pressure (SBP/DBP) and heart rate (HR), at pre-dose baseline, and 3, 8, 15, 30, 90, and 360 min post-dose.
  • 12-lead ECG (for routine and QT/QTc) [ Time Frame: Visits 1-7 at baseline, 10, 50 and 360 minutes post-dose ]
    Measurement of 12-lead ECG (for routine and QT/QTc), at pre-dose baseline, and at 10, 50, and 360 min post-dose.
  • Serum glucose [ Time Frame: Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose ]
    Determination of Serum glucose, at pre-dose baseline, and at 15, 35 and 120 min post-dose.
  • Serum potassium [ Time Frame: Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose ]
    Determination of serum potassium levels, at pre-dose baseline, and at 15, 35 and 120 min post-dose.
  • Asthma exacerbation incidents [ Time Frame: Visits 1-7 and EOS ]
    Evaluation of asthma exacerbation incidents in all patients throughout the duration of the study.
  • Asthma management/ rescue drug usage [ Time Frame: Visits 1-7 and EOS ]
    Evaluation of asthma exacerbation incidents in all patients throughout the duration of the study.
  • Physical examination [ Time Frame: Screening and End-of-Study Visit ]
    Physical examination of all subjects performed at screening and end-of-study visit to evaluate subject's general health.
  • CBC [ Time Frame: Screening and End-of-Study Visit ]
    Evaluation of CBC in all subjects at screening and end-of-study visit.
  • Comprehensive metabolic panel [ Time Frame: Screening and End-of-Study Visit ]
    Comprehensive metabolic panel performed on all subjects at screening and end-of-study visit.
  • Urinalysis [ Time Frame: Screening and End-of-Study Visit ]
    Urinalysis performed on all subjects at screening and end-of-study visit.
  • Pregnancy test [ Time Frame: Screening and End-of-Study Visit ]
    A pregnancy test for women of child bearing potential at screening and end-of-study visit.
  • Medication interactions [ Time Frame: Screening, Visits 1-7 and End-of-Study Visit ]
    Evaluation of concomitant medications used by subjects throughout the study and their potential to affect the study
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Screening, Visits 1-7, End-of-Study Visit ]
    Adverse drug events whether observed by investigators or reported by subjects, will be documented, evaluated, followed up, and treated if deemed necessary.
Same as current
Not Provided
Not Provided
 
Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
A Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Crossover Dose-ranging Study of A006 in Adult Asthma Patients

The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.

This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.

The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dose in comparison to the DPI Placebo Control and the Active (Reference) Control. The study results of this study together with that of A006-B study will be utilized to determine the optimum final dose range of A006 for further clinical studies.

The study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Albuterol DPI 25 mcg/inh
    Albuterol DPI with 25 mcg Albuterol/inhalation
  • Drug: Albuterol DPI 90 mcg/inh
    Albuterol DPI with 90 mcg Albuterol/inhalation
  • Drug: Placebo DPI
    Placebo DPI with 0 mcg Albuterol/inhalation
  • Drug: Albuterol MDI 90 mcg/inh
    Albuterol MDI with 90 mcg Albtuerol/inhalation
  • Experimental: T1
    Two inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg
    Interventions:
    • Drug: Albuterol DPI 25 mcg/inh
    • Drug: Placebo DPI
  • Experimental: T2
    Two inhalations of Albuterol DPI 25 mcg/inh; Total Albuterol dose of 50 mcg
    Intervention: Drug: Albuterol DPI 25 mcg/inh
  • Experimental: T3
    Two inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg
    Interventions:
    • Drug: Albuterol DPI 90 mcg/inh
    • Drug: Placebo DPI
  • Experimental: T4
    Two inhalations of Albuterol DPI 90 mcg/inh; Total Albuterol dose of 180 mcg
    Intervention: Drug: Albuterol DPI 90 mcg/inh
  • Placebo Comparator: P
    Two inhalations Placebo DPI; Total Albuterol dose of 0 mcg
    Intervention: Drug: Placebo DPI
  • Active Comparator: R1
    One inhalation of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 90 mcg
    Intervention: Drug: Albuterol MDI 90 mcg/inh
  • Active Comparator: R2
    Two inhalations of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 180 mcg
    Intervention: Drug: Albuterol MDI 90 mcg/inh

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
August 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Generally healthy, male and female adults, 18-55 years of age at screening
  • With mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler
  • Demonstrate a Forced Expiratory Volume (FEV1) at 50-85 percent of predicted normal during screening baseline measurement
  • Demonstrate an airway reversibility of greater than or equal to 15 percent within 30 minutes of inhaling 2 inhalations of Proventil MDI during screening visit
  • Demonstrate Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), at least 2 times consecutively
  • Demonstrate ability to use a DPI and MDI inhaler properly after training
  • Females must be not pregnant, not lactating, and using a clinically acceptable form of birth control
  • Properly agree to participate in the trial

Exclusion Criteria:

  • A smoking history of more than or equal to 10 years or having smoked within 6 months of screening visit
  • Upper respiratory tract infections within 2 weeks or lower respiratory tract infection within 4 weeks prior to screening visit
  • Asthma exacerbations that required emergency care or a hospital stay within 4 weeks prior to screening visit
  • Any current or recent respiratory tract infections that might affect the response to the study drug as determined by the investigator, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema and other significant respiratory diseases besides asthma
  • Current clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could impact the study as determined by the investigator
  • Known intolerance or hypersensitivity to any ingredients of the study drug DPI or Proventil MDI (i.e.: Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid and ethanol)
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01581177
API-A006-CL-B2
No
Not Provided
Not Provided
Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc.
Not Provided
Study Director: Safety Monitor Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc.
May 2017

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