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

Purpose

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.

Condition	Intervention	Phase
Asthma Bronchospasm	Drug: albuterol inhalation powder Drug: Placebo Drug: albuterol inhalation aerosol	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Amphastar Pharmaceuticals, Inc.:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Enrollment:	26
Study Start Date:	July 2010
Study Completion Date:	January 2011
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: T1 A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation	Drug: albuterol inhalation powder A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation
Experimental: T2 A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation	Drug: albuterol inhalation powder A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation
Experimental: T3 A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations	Drug: albuterol inhalation powder A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
Experimental: T4 A006 albuterol inhalation powder 180 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 Name: Proventil
Active Comparator: R2 Proventil 90 mcg/inhalation, 4 inhalations	Drug: albuterol inhalation aerosol albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations Other Name: Proventil

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174732

Locations

United States, California
Ampahstar Site 4
San Jose, California, United States, 95117
United States, Colorado
Ampahstar Stie 2
Centennial, Colorado, United States, 80112
Amphastar Site 1
Denver, Colorado, United States, 80230
Amphastar Site 3
Lakewood, Colorado, United States, 80401

Sponsors and Collaborators

Amphastar Pharmaceuticals, Inc.

Investigators

Study Director:

Medical Director

Amphastar Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01174732 History of Changes
Other Study ID Numbers:	API-A006-CL-B
Study First Received:	July 29, 2010
Last Updated:	January 23, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amphastar Pharmaceuticals, Inc.:

asthma
bronchospasm
COPD
chronic respiratory disease

Additional relevant MeSH terms:

Asthma
Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 16, 2013