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

April 17, 2017 updated by: Amphastar Pharmaceuticals, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Effect
Time Frame: 0 to 360 minutes
Time to onset of bronchodilator effect
0 to 360 minutes
Peak Response
Time Frame: 0 - 360 minutes
peak bronchodilator response
0 - 360 minutes
Duration
Time Frame: 0 - 360 minutes
Duration of effect
0 - 360 minutes
Response Rate
Time Frame: 0 - 360 minutes
Bronchodilatory Response Rate
0 - 360 minutes
Hand Tremor
Time Frame: within 5 min. prior to dosing and 50 and 360 min post-dose.
Evaluation of hand tremor
within 5 min. prior to dosing and 50 and 360 min post-dose.
Vital Signs
Time Frame: within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.
Pulse, heartrate, respirations, blood pressure
within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.
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
within 15 min. prior to dosing and at 50 and 360 min postdose.
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
within 15 min. prior to dosing, and 30 and 120 min. postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amphastar Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • API-A006-CL-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings