NCT01174732

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

July 29, 2010

Last Update Submit

April 17, 2017

Conditions

AsthmaBronchospasm

Keywords

asthmabronchospasmCOPDchronic respiratory disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Time to Effect

    0 to 360 minutes

  • Peak Response

    0 - 360 minutes

  • Duration

    0 - 360 minutes

  • Response Rate

    0 - 360 minutes

  • Hand Tremor

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

  • +3 more secondary outcomes

Study Arms (7)

T1

EXPERIMENTAL

A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation

Drug: albuterol inhalation powder

T2

EXPERIMENTAL

A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation

Drug: albuterol inhalation powder

T3

EXPERIMENTAL

A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations

Drug: albuterol inhalation powder

T4

EXPERIMENTAL

A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations

Drug: albuterol inhalation powder

P

PLACEBO COMPARATOR

Placebo, 2 inhalations

Drug: Placebo

R1

ACTIVE COMPARATOR

Proventil 90 mcg/inhalation, 2 inhalations

Drug: albuterol inhalation aerosol

R2

ACTIVE COMPARATOR

Proventil 90 mcg/inhalation, 4 inhalations

Drug: albuterol inhalation aerosol

Interventions

albuterol inhalation powderDRUG

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

T1
PlaceboDRUG

placebo, lactose inhalation carrier

P
albuterol inhalation aerosolDRUG

albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations

Also known as: Proventil
R1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Amphastar Site 0001

San Jose, California, 95117, United States

Location

Amphastar Site 0007

Centennial, Colorado, 80112, United States

Location

Amphastar Site 0008

Denver, Colorado, 80230, United States

Location

Amphastar Site 0039

Lakewood, Colorado, 80401, United States

Location

MeSH Terms

Conditions

AsthmaBronchial SpasmPulmonary Disease, Chronic Obstructive

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Safety Monitor

    Amphastar Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2010

First Posted

August 4, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2010

Study Completion

January 1, 2011

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

US(4)