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Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Albuterol-HFA-MDI
Albuterol-HFA-BAI
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma and Poor Coordinators of Asthma Inhalers

Eligibility Criteria

7 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Asthma of a minimum of 6 months duration
  • Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts
  • Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol
  • The reversibility (FEV1) of ≤70% following administration of the initial 90 mcg of albuterol
  • Ability to perform spirometry reproducibly
  • Ability to self-perform peak expiratory flow (PEF) determinations and report scores on diaries
  • Can tolerate withdrawal of applicable medications for qualification at screening
  • Otherwise healthy individuals
  • Non-smokers for at least 2 years prior to the screening visit

Exclusion Criteria:

  • Allergy or sensitivity to albuterol
  • Exposure to investigational drugs within 30 days prior to the screening visit
  • Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
  • Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit
  • The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit
  • Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
  • Hospitalization for acute exacerbation of asthma more than twice in past year
  • Treatment in an emergency room or hospitalization for asthmatic symptoms within 3 months prior to the screening visit
  • An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 weeks prior to the screening visit
  • History and/or presence of any clinically significant non-asthmatic acute or chronic disease
  • Known or suspected substance abuse
  • Previous enrollment in an IVAX Research-sponsored Albuterol-HFA asthma study Note: Other inclusion and exclusion criteria may apply.

Sites / Locations

  • Clinical Study Site
  • Teva Clinical Study Site
  • Clinical Study Site
  • Clinical Study Site
  • Clinical Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Albuterol-HFA-BAI

Albuterol-HFA-MDI

Arm Description

Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2.

Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2.

Outcomes

Primary Outcome Measures

Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.

Secondary Outcome Measures

Percent Change From Baseline in FEV1 Within 30 Minutes Postdose
The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Percent Change From Baseline in FEV1 up to 2 Hours Postdose
The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The test-day baseline consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
The number of minutes required for the baseline FEV1 to increase by at least 12% within the 2-hour observation period. Median time and corresponding confidence intervals (CIs) were obtained via the Kaplan-Meier estimate.
Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
The number of minutes required for the baseline FEV1 to increase by at least 15% within the 2-hour observation period. Median time and corresponding CIs were obtained via the Kaplan-Meier estimate.
Time to Maximum Increase in FEV1
Each calculation for FEV1 took several minutes in order to obtain the highest of 3 measurements. The total collection time exceeded the 120 mins post-dose time frame for some participants.

Full Information

First Posted
September 14, 2007
Last Updated
September 1, 2022
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00530062
Brief Title
Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma
Official Title
Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 25, 2007 (Actual)
Primary Completion Date
October 24, 2008 (Actual)
Study Completion Date
October 24, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma and Poor Coordinators of Asthma Inhalers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albuterol-HFA-BAI
Arm Type
Experimental
Arm Description
Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2.
Arm Title
Albuterol-HFA-MDI
Arm Type
Active Comparator
Arm Description
Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2.
Intervention Type
Drug
Intervention Name(s)
Albuterol-HFA-MDI
Other Intervention Name(s)
Albuterol, ProAir
Intervention Description
Inhalation Aerosols, 90 mcg, 1 dose per treatment period
Intervention Type
Drug
Intervention Name(s)
Albuterol-HFA-BAI
Other Intervention Name(s)
Albuterol
Intervention Description
Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
Primary Outcome Measure Information:
Title
Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2
Description
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Time Frame
Baseline, Up to 2 hours postdose
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in FEV1 Within 30 Minutes Postdose
Description
The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Time Frame
Baseline up to 30 minutes postdose
Title
Percent Change From Baseline in FEV1 up to 2 Hours Postdose
Description
The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Time Frame
Baseline up to 2 hours postdose
Title
Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2
Description
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The test-day baseline consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
Time Frame
Baseline up to 2 hours postdose
Title
Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
Time Frame
Baseline up to 2 hours postdose
Title
Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
Time Frame
Baseline up to 2 hours postdose
Title
Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
Description
The number of minutes required for the baseline FEV1 to increase by at least 12% within the 2-hour observation period. Median time and corresponding confidence intervals (CIs) were obtained via the Kaplan-Meier estimate.
Time Frame
Baseline up to 2 hours postdose
Title
Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
Description
The number of minutes required for the baseline FEV1 to increase by at least 15% within the 2-hour observation period. Median time and corresponding CIs were obtained via the Kaplan-Meier estimate.
Time Frame
Baseline up to 2 hours postdose
Title
Time to Maximum Increase in FEV1
Description
Each calculation for FEV1 took several minutes in order to obtain the highest of 3 measurements. The total collection time exceeded the 120 mins post-dose time frame for some participants.
Time Frame
Baseline up to 2 hours postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asthma of a minimum of 6 months duration Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol The reversibility (FEV1) of ≤70% following administration of the initial 90 mcg of albuterol Ability to perform spirometry reproducibly Ability to self-perform peak expiratory flow (PEF) determinations and report scores on diaries Can tolerate withdrawal of applicable medications for qualification at screening Otherwise healthy individuals Non-smokers for at least 2 years prior to the screening visit Exclusion Criteria: Allergy or sensitivity to albuterol Exposure to investigational drugs within 30 days prior to the screening visit Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications Hospitalization for acute exacerbation of asthma more than twice in past year Treatment in an emergency room or hospitalization for asthmatic symptoms within 3 months prior to the screening visit An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 weeks prior to the screening visit History and/or presence of any clinically significant non-asthmatic acute or chronic disease Known or suspected substance abuse Previous enrollment in an IVAX Research-sponsored Albuterol-HFA asthma study Note: Other inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Study Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Teva Clinical Study Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Clinical Study Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Study Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Clinical Study Site
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Learn more about this trial

Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma

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