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Completed

NCT Number: NCT01174732

Dose-Ranging Study of A006 DPI, 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.

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Key information

Conditions

Asthma Bronchial Diseases Bronchial Spasm Bronchospasm Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amphastar Site 0001, San Jose, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

albuterol inhalation powder

Drug

A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation

Placebo

Drug

placebo, lactose inhalation carrier

albuterol inhalation aerosol

Drug

albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations

Other names: Proventil

Primary outcomes

  1. AUC

    Time frame: 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.

    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 outcomes

  1. Time to Effect

    Time frame: 0 to 360 minutes

    Time to onset of bronchodilator effect

  2. Peak Response

    Time frame: 0 - 360 minutes

    peak bronchodilator response

  3. Duration

    Time frame: 0 - 360 minutes

    Duration of effect

  4. Response Rate

    Time frame: 0 - 360 minutes

    Bronchodilatory Response Rate

  5. Hand Tremor

    Time frame: within 5 min. prior to dosing and 50 and 360 min post-dose.

    Evaluation of hand tremor

  6. Vital Signs

    Time frame: within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.

    Pulse, heartrate, respirations, blood pressure

  7. 12 lead ECG

    Time frame: within 15 min. prior to dosing and at 50 and 360 min postdose.

    12-lead ECG for routine and QT/QTc evaluations

  8. Blood Work

    Time frame: within 15 min. prior to dosing, and 30 and 120 min. postdose

    Collect blood samples (~5 mL) for serum glucose and K+ tests

Sponsors and collaborators

Lead sponsor

Amphastar Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Aug 4, 2010
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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