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

Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Albuterol-HFA-BAI; Drug: Albuterol-HFA-MDI

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States, 92647
      • Clinical Study Site
  • Colorado
    • Lakewood, Colorado, United States, 80401
      • Teva Clinical Study Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Study Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Clinical Study Site
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Albuterol-HFA-BAI; Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2.	Drug: Albuterol-HFA-BAI; Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.; Other Names: Albuterol
ACTIVE_COMPARATOR: Albuterol-HFA-MDI; Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2.	Drug: Albuterol-HFA-MDI; Inhalation Aerosols, 90 mcg, 1 dose per treatment period; Other Names: Albuterol; ProAir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Up to 2 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 30 minutes postdose
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.	Baseline up to 2 hours postdose
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.	Baseline up to 2 hours postdose
Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose		Baseline up to 2 hours postdose
Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose		Baseline up to 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.	Baseline up to 2 hours postdose
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.	Baseline up to 2 hours postdose
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.	Baseline up to 2 hours postdose

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 25, 2007
• Primary Completion (ACTUAL): October 24, 2008
• Study Completion (ACTUAL): October 24, 2008

Study Registration Dates

• First Submitted: September 14, 2007
• First Submitted That Met QC Criteria: September 14, 2007
• First Posted (ESTIMATE): September 17, 2007

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Asthma and Poor Coordinators of Asthma Inhalers
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: IXR-404-04-167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.