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

Amphastar Pharmaceuticals, Inc.23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Asthma

Interventions

Albuterol DPI 25 mcg/inhDRUG

Albuterol DPI with 25 mcg Albuterol/inhalation

Albuterol DPI 90 mcg/inhDRUG

Albuterol DPI with 90 mcg Albuterol/inhalation

Placebo DPIDRUG

Placebo DPI with 0 mcg Albuterol/inhalation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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)

Locations (4)

Amphastar Site 0001

San Jose, California, United States

Amphastar Site 0025

Medford, Oregon, United States

Amphastar Site 0030

New Braunfels, Texas, United States

Amphastar Site 0032

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Change in FEV1 Area Under the Curve (AUC) versus placebo

Serial FEV1 measurements to demonstrate the mean AUC change in percent FEV1 from same-day baseline of A006 versus placebo control

Time frame: Visits 1-7, at baseline, 5, 20, 30, 60, 90, 120, 240, 360 minutes post-dose

Secondary Outcomes

Placebo AUC of adjusted FEV1 changes

Determination of change of FEV1 in placebo arm

Time frame: Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose

AUC of post-dose FEV1 volume changes from pre-dose baseline to Visit 7

Determination of FEV1 volume change from pre-dose baseline to post treatment at Visit 7

Time frame: Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose

Time post-dose change in FEV1 percent first reaches greater than or equal to 12 percent over the Pre-dose Baseline

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.

Time frame: Visits 1-7, at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose

Peak bronchodilator response (Fmax)

The peak bronchodilator response (Fmax), defined as the maximum post-dose change in FEV1 percent.

Time frame: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose

Time to peak FEV1 effect (tmax)

The time to peak FEV1 effect (tmax), defined as the time of Fmax.

Time frame: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose

Data from ClinicalTrials.gov

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