Back to resultsAlbuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation (A006-B3)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
A006 DPI
A006 DPI
Placebo DPI
Proventil® MDI
Proventil® MDI
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Mild-to-moderate persistent asthma, Mild asthma, Moderate asthma, Persistent asthma
Eligibility Criteria
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 inhaled β-agonist(s) for asthma control
- Demonstrating a Screening Baseline FEV1 at 50.0 - 85.0% of predicted normal
- Demonstrating a ≥ 15.0% Airway Reversibility in FEV1 within 30 min after inhaling 2 actuations of Proventil® MDI (180 mcg) at Screening
- Demonstrating Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), for at least 2 times consecutively with a maximum of 5 attempts
- Demonstrating proficiency in the use of a DPI and an MDI after training
- Females of child-bearing potential must be non-pregnant, non-lactating; both males and females enrolled into the study must agree to practice a clinically acceptable form of birth control (including but not limited to, abstinence, double barrier, etc)
- Having properly consented to participate in the trial
Exclusion Criteria:
- A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to Screening
- Upper respiratory tract infections or lower respiratory tract infection within 6 weeks, prior to Screening
- Asthma exacerbations that required emergency care or hospitalized treatment, within 4 weeks prior to Screening
- Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma
- Concurrent clinically significant cardiovascular (e.g. hypertension and tachyarrhythmia and bradyarrhythmia), hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
- Known intolerance or hypersensitivity to any of the ingredients of the study drug DPI or Proventil® HFA MDI (i.e., Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid, and ethanol)
- Baseline ECG at Screening or Visit 1 showing any single or multiple premature ventricular contractions (PVC)
- Baseline ECG at Screening or Visit 1 with a confirmed (through performing a second ECG) QTc reading greater than 450ms
- 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 prior to Screening.
Sites / Locations
- Amphastar Site 0001
- Amphastar Site 0025
- Amphastar Site 0030
- Amphastar Site 0032
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Treatment T1
Treatment T2
Placebo
Treatment R1
Treatment R2
Arm Description
One inhalation of 110 mcg A006 DPI. Total 110 mcg.
One inhalation of 220 mcg A006 DPI. Total 220 mcg.
One inhalation of placebo DPI . Total 0 mcg
One inhalation of Proventil® MDI Total 90 mcg
Two inhalations of Proventil® MDI, 180 mcg total
Outcomes
Primary Outcome Measures
Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Percentage Change (∆%FEV1) from the Same-Day Pre-Dose Baseline
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Area under the curve (AUC), from baseline to 6 hours post-dose, for the treatment period is calculated using the trapezoidal rule. Statistical analysis is performed using a one-sided t-test.
Secondary Outcome Measures
Area Under the Curve (AUC[0-6h]) of Placebo Adjusted Post-Dose FEV1 Percentage Change (∆∆%FEV1) from the Same-Day Pre-Dose Baseline
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. ∆∆FEV1% for the study visit is calculated by subtracting the mean ∆%FEV1 for subjects in a randomized treatment arm from their ∆%FEV1. Area under the curve (AUC), from baseline to 6 hours post-dose, for the study visit is calculated using the trapezoidal rule.
Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Volume Changes (∆FEV1) from the Same-Day Pre-Dose Baseline
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Area under the curve (AUC), from baseline to 6 hours post-dose, for the treatment period is calculated using the trapezoidal rule.
Time to Onset of Bronchodilator Effect (t[onset])
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. t[onset] is the point where post-dose ∆%FEV1 first reaches ≥ 12% over the pre-dose baseline. Determined by linear interpolation.
Peak Bronchodilator Response (F[max])
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. F[max] is the maximum post-dose ∆%FEV1.
Time to Peak ∆FEV1 Effect (t[max])
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. The time to peak ∆FEV1 effect, t[max], is defined as the time of F[max].
Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 in Volume from the Same-Day Pre-Dose Baseline
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Area under the curve (AUC), from baseline to 6 hours post-dose, for the treatment period is calculated using the trapezoidal rule.
F[max] of Post-Dose FEV1 in Volume
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. F[max] of post-dose FEV1 in volume is the maximum post-dose FEV1.
Efficacy Duration-1
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Efficacy Duration-1 is total duration of bronchodilator effects when ∆%FEV1 is ≥ 12% above the baseline.
Efficacy Duration-2
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Efficacy Duration-2 is total duration of bronchodilator effects when ∆FEV1 is ≥ 200 mL above the baseline.
Efficacy Duration-3
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Efficacy Duration-3 is total duration of bronchodilator effects when ∆FEV1 is ≥ 100 mL above the baseline.
Bronchodilator Response
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Subjects that demonstrate a ≥ 12% increase for ∆%FEV1 will be classified as having a bronchodilator response.
Dose Response Curve
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. The dose response curve is the AUC[0-6h] of ∆%FEV1 versus study drug dosage.
Full Information
NCT ID
NCT02210806
First Posted
August 4, 2014
Last Updated
April 17, 2017
Sponsor
Amphastar Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02210806
Brief Title
Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation
Acronym
A006-B3
Official Title
Efficacy, Dose-ranging and Safety Evaluation (A Randomized, Double- or Evaluator-blinded, Active- and Placebo-controlled, Single Dose, Five-arm, Crossover, and Dose-ranging Study of A006 in Adult Asthma Patients)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (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 evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.
Detailed Description
This study is designed to evaluate the efficacy and safety profiles of A006 and to assist in identifying the optimum dose of A006 for future clinical studies. Proventil® HFA MDI, a currently marketed Albuterol MDI product, will be used as an Active Control. The study also employs a Placebo Control DPI, which has the same configuration as the A006 DPI except that it contains no active ingredient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Mild-to-moderate persistent asthma, Mild asthma, Moderate asthma, Persistent asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment T1
Arm Type
Active Comparator
Arm Description
One inhalation of 110 mcg A006 DPI. Total 110 mcg.
Arm Title
Treatment T2
Arm Type
Active Comparator
Arm Description
One inhalation of 220 mcg A006 DPI. Total 220 mcg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One inhalation of placebo DPI . Total 0 mcg
Arm Title
Treatment R1
Arm Type
Active Comparator
Arm Description
One inhalation of Proventil® MDI Total 90 mcg
Arm Title
Treatment R2
Arm Type
Active Comparator
Arm Description
Two inhalations of Proventil® MDI, 180 mcg total
Intervention Type
Drug
Intervention Name(s)
A006 DPI
Other Intervention Name(s)
Albuterol, Albuterol DPI
Intervention Description
Single dose 110 mcg, 1 inhalation
Intervention Type
Drug
Intervention Name(s)
A006 DPI
Other Intervention Name(s)
Albuterol, Albuterol DPI
Intervention Description
Single dose 220 mcg, 1 inhalation
Intervention Type
Other
Intervention Name(s)
Placebo DPI
Other Intervention Name(s)
Placebo
Intervention Description
Placebo, 1 inhalation
Intervention Type
Drug
Intervention Name(s)
Proventil® MDI
Other Intervention Name(s)
Proventil®
Intervention Description
Single dose 90 mcg, 1 inhalation
Intervention Type
Drug
Intervention Name(s)
Proventil® MDI
Other Intervention Name(s)
Proventil®
Intervention Description
Single dose 90 mcg, 2 inhalations
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Percentage Change (∆%FEV1) from the Same-Day Pre-Dose Baseline
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Area under the curve (AUC), from baseline to 6 hours post-dose, for the treatment period is calculated using the trapezoidal rule. Statistical analysis is performed using a one-sided t-test.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Secondary Outcome Measure Information:
Title
Area Under the Curve (AUC[0-6h]) of Placebo Adjusted Post-Dose FEV1 Percentage Change (∆∆%FEV1) from the Same-Day Pre-Dose Baseline
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. ∆∆FEV1% for the study visit is calculated by subtracting the mean ∆%FEV1 for subjects in a randomized treatment arm from their ∆%FEV1. Area under the curve (AUC), from baseline to 6 hours post-dose, for the study visit is calculated using the trapezoidal rule.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Volume Changes (∆FEV1) from the Same-Day Pre-Dose Baseline
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Area under the curve (AUC), from baseline to 6 hours post-dose, for the treatment period is calculated using the trapezoidal rule.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Time to Onset of Bronchodilator Effect (t[onset])
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. t[onset] is the point where post-dose ∆%FEV1 first reaches ≥ 12% over the pre-dose baseline. Determined by linear interpolation.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Peak Bronchodilator Response (F[max])
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. F[max] is the maximum post-dose ∆%FEV1.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Time to Peak ∆FEV1 Effect (t[max])
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. The time to peak ∆FEV1 effect, t[max], is defined as the time of F[max].
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 in Volume from the Same-Day Pre-Dose Baseline
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Area under the curve (AUC), from baseline to 6 hours post-dose, for the treatment period is calculated using the trapezoidal rule.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
F[max] of Post-Dose FEV1 in Volume
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. F[max] of post-dose FEV1 in volume is the maximum post-dose FEV1.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Efficacy Duration-1
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Efficacy Duration-1 is total duration of bronchodilator effects when ∆%FEV1 is ≥ 12% above the baseline.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Efficacy Duration-2
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Efficacy Duration-2 is total duration of bronchodilator effects when ∆FEV1 is ≥ 200 mL above the baseline.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Efficacy Duration-3
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Efficacy Duration-3 is total duration of bronchodilator effects when ∆FEV1 is ≥ 100 mL above the baseline.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Bronchodilator Response
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. Subjects that demonstrate a ≥ 12% increase for ∆%FEV1 will be classified as having a bronchodilator response.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Dose Response Curve
Description
The forced expiratory volume in the 1st second (FEV1) is measured with a clinically accepted model of spirometer. Subjects perform a pre-dose baseline FEV1 prior to dosing and perform subsequent FEV1 tests at 5, 15 and 30 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours after dosing during each treatment period. The dose response curve is the AUC[0-6h] of ∆%FEV1 versus study drug dosage.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Other Pre-specified Outcome Measures:
Title
Systolic and Diastolic Blood Pressure (SBP/DBP) at Screening
Description
Subjects have their vital signs, i.e., blood pressure and heart rate, measured prior to reversibility dosing and 30 minutes after dosing during the Screening Visit.
Time Frame
Within 30 minutes prior to reversibility dosing (baseline) and 30 minutes post-reversibility dosing
Title
Systolic and Diastolic Blood Pressure (SBP/DBP)
Description
Subjects have their vital signs, i.e., blood pressure and heart rate, measured prior to dosing and at 15 and 30 minutes and 1, 1.5, 2, and 6 hours post-dose during each treatment period.
Time Frame
Within 1 hour prior to dosing (baseline) to 6 hours post-dose
Title
Heart Rate (HR) at Screening
Description
Subjects have their vital signs, i.e., blood pressure and heart rate, measured prior to reversibility dosing and 30 minutes after dosing during the Screening Visit.
Time Frame
Within 30 minutes prior to reversibility dosing (baseline) and 30 minutes post-reversibility dosing
Title
Heart Rate (HR)
Description
Subjects have their vital signs, i.e., blood pressure and heart rate, measured prior to dosing and at 15 and 30 minutes and 1, 1.5, 2, and 6 hours post-dose during each treatment period.
Time Frame
Within 1 hour prior to dosing (baseline) to 6 hours post-dose
Title
12-Lead ECG QT/QTc Intervals at Screening
Description
12-Lead ECGs are performed to measure QT and QTc intervals prior to reversibility dosing during the Screening Visit.
Time Frame
Within 1 hour prior to reversibility dosing
Title
12-Lead ECG QT/QTc Intervals
Description
12-Lead ECGs are performed to measure QT and QTc intervals prior to dosing and at 30 minutes and 1, 2, and 6 hours post-dose during each treatment period.
Time Frame
Within 1 hour prior to dosing (baseline) to 6 hours post-dose
Title
Number of Subjects with Incidents of Asthma Exacerbation
Description
An asthma exacerbation incident is defined as significant worsening of clinical symptoms that cannot be adequately relieved by the rescue medication, or significant deterioration of FEV1 tests combined with clinical symptoms. Investigators monitor worsening of asthma symptoms during the treatment period and determine if subjects had experienced an asthma exacerbation.
Time Frame
Participants will be followed for the duration of the study, an expected average of 3 weeks
Title
Number of Subjects that Used Rescue Drug
Description
Rescue medication may be used to control worsening or exacerbations of asthma symptoms during the study visits when necessary, as determined by the investigator.
Time Frame
Within 30 minutes prior to dosing (baseline) to 6 hours post-dose
Title
Complete Blood Count (CBC) at Screening
Description
A CBC is performed as part of the subject safety evaluations with differentials including: red blood cell (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and white blood cell types (WBC).
Time Frame
Within 1 hour after reversibility dosing
Title
Complete Blood Count (CBC) at End-of-Study
Description
A CBC is performed as part of the subject safety evaluations with differentials including: red blood cell (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and white blood cell types (WBC).
Time Frame
120 minutes post-dose at Visit 5 (within 57 days after Visit 1)
Title
Comprehensive Metabolic Panel (CMP) at Screening
Description
A CMP is performed as part of the subject safety evaluations looking at levels for the following: total protein (albumin/globulin), sodium, chloride, potassium, glucose, calcium, carbon dioxide (CO2), blood urea nitrogen (BUN), creatinine, alkaline phosphate (ALP), alanine transaminase (ALT), aspartate transaminase (AST), and bilirubin.
Time Frame
Within 1 hour after reversibility dosing
Title
Comprehensive Metabolic Panel (CMP) at End-of-Study
Description
A CMP is performed as part of the subject safety evaluations looking at levels for the following: total protein (albumin/globulin), sodium, chloride, potassium, glucose, calcium, carbon dioxide (CO2), blood urea nitrogen (BUN), creatinine, alkaline phosphate (ALP), alanine transaminase (ALT), aspartate transaminase (AST), and bilirubin.
Time Frame
120 minutes post-dose at Visit 5 (within 57 days after Visit 1)
Title
Urinalysis at Screening
Description
Routine and microscopic urinalysis is performed as part of the subject safety evaluations to measure urine pH and specific gravity.
Time Frame
Within 1 hour after reversibility dosing
Title
Urinalysis at End-of-Study
Description
Routine and microscopic urinalysis is performed as part of the subject safety evaluations to measure urine pH and specific gravity.
Time Frame
120 minutes post-dose at Visit 5 (within 57 days after Visit 1)
Title
Incidents of Pregnancy at Screening
Description
A urinary pregnancy test was performed for women of child-bearing potential as a part of the Screening Visit evaluations to determine the eligibility of the subject for the study.
Time Frame
Within 1 hour prior to reversibility dosing
Title
Incidents of Pregnancy at End-of-Study
Description
A urinary pregnancy test was performed for women of child-bearing potential as a part of the End-of-Study safety evaluations to determine if a pregnancy had occurred during the study.
Time Frame
At or after 120 minutes post-dose at Visit 5 (within 57 days after Visit 1)
Title
Concomitant Medication Usage
Description
Concomitant medications used by subjects throughout the duration of the study, from 30 days prior to Screening to End-of-Study evaluations, are recorded by the investigators. The total number of times a specific concomitant medication is used during the study is summarized.
Time Frame
Participants will be followed for the duration of the study, an expected average of 3 weeks
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:
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 inhaled β-agonist(s) for asthma control
Demonstrating a Screening Baseline FEV1 at 50.0 - 85.0% of predicted normal
Demonstrating a ≥ 15.0% Airway Reversibility in FEV1 within 30 min after inhaling 2 actuations of Proventil® MDI (180 mcg) at Screening
Demonstrating Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), for at least 2 times consecutively with a maximum of 5 attempts
Demonstrating proficiency in the use of a DPI and an MDI after training
Females of child-bearing potential must be non-pregnant, non-lactating; both males and females enrolled into the study must agree to practice a clinically acceptable form of birth control (including but not limited to, abstinence, double barrier, etc)
Having properly consented to participate in the trial
Exclusion Criteria:
A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to Screening
Upper respiratory tract infections or lower respiratory tract infection within 6 weeks, prior to Screening
Asthma exacerbations that required emergency care or hospitalized treatment, within 4 weeks prior to Screening
Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma
Concurrent clinically significant cardiovascular (e.g. hypertension and tachyarrhythmia and bradyarrhythmia), hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
Known intolerance or hypersensitivity to any of the ingredients of the study drug DPI or Proventil® HFA MDI (i.e., Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid, and ethanol)
Baseline ECG at Screening or Visit 1 showing any single or multiple premature ventricular contractions (PVC)
Baseline ECG at Screening or Visit 1 with a confirmed (through performing a second ECG) QTc reading greater than 450ms
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 prior to Screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safety Monitor
Organizational Affiliation
Amphastar Pharmeceuticals, 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 0025
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Amphastar Site 0030
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Amphastar Site 0032
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9695144
Citation
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Citation
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Results Reference
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Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation
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