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.

Study Overview

• Status: Completed
• Conditions: Asthma; Bronchospasm
• Intervention / Treatment: Drug: albuterol inhalation powder; Drug: albuterol inhalation powder; Drug: albuterol inhalation powder; Drug: albuterol inhalation powder; Drug: Placebo; Drug: albuterol inhalation aerosol; Drug: albuterol inhalation aerosol

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95117
      • Amphastar Site 0001
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Amphastar Site 0007
    • Denver, Colorado, United States, 80230
      • Amphastar Site 0008
    • Lakewood, Colorado, United States, 80401
      • Amphastar Site 0039

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: T1; A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation	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
EXPERIMENTAL: T2; A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation	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
EXPERIMENTAL: T3; A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations	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
EXPERIMENTAL: T4; A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations	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
PLACEBO_COMPARATOR: P; Placebo, 2 inhalations	Drug: Placebo; placebo, lactose inhalation carrier
ACTIVE_COMPARATOR: R1; Proventil 90 mcg/inhalation, 2 inhalations	Drug: albuterol inhalation aerosol; albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations; Other Names: Proventil; Drug: albuterol inhalation aerosol; albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations; Other Names: Proventil
ACTIVE_COMPARATOR: R2; Proventil 90 mcg/inhalation, 4 inhalations	Drug: albuterol inhalation aerosol; albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations; Other Names: Proventil; Drug: albuterol inhalation aerosol; albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations; Other Names: Proventil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Effect	Time to onset of bronchodilator effect	0 to 360 minutes
Peak Response	peak bronchodilator response	0 - 360 minutes
Duration	Duration of effect	0 - 360 minutes
Response Rate	Bronchodilatory Response Rate	0 - 360 minutes
Hand Tremor	Evaluation of hand tremor	within 5 min. prior to dosing and 50 and 360 min post-dose.
Vital Signs	Pulse, heartrate, respirations, blood pressure	within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.
12 lead ECG	12-lead ECG for routine and QT/QTc evaluations	within 15 min. prior to dosing and at 50 and 360 min postdose.
Blood Work	Collect blood samples (~5 mL) for serum glucose and K+ tests	within 15 min. prior to dosing, and 30 and 120 min. postdose

Collaborators and Investigators

• Sponsor: Amphastar Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (ESTIMATE): August 4, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: COPD; asthma; bronchospasm; chronic respiratory disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Bronchial Spasm; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: API-A006-CL-B