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

NCT00530062 | Completed Phase 4 Results DMC

• 1 other identifier: IXR-404-04-167
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

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.

Conditions

Asthma

Keywords

Asthma and Poor Coordinators of Asthma Inhalers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percent Change From Baseline in FEV1 Within 30 Minutes Postdose

  Baseline up to 30 minutes postdose

• Percent Change From Baseline in FEV1 up to 2 Hours Postdose

  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

  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

Study Arms (2)

Albuterol-HFA-BAI

EXPERIMENTAL

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

Drug: Albuterol-HFA-BAI

Albuterol-HFA-MDI

ACTIVE COMPARATOR

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

Drug: Albuterol-HFA-MDI

Interventions

Albuterol-HFA-MDI DRUG

Inhalation Aerosols, 90 mcg, 1 dose per treatment period

Also known as: Albuterol, ProAir

Albuterol-HFA-MDI

Albuterol-HFA-BAI DRUG

Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.

Also known as: Albuterol

Albuterol-HFA-BAI

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (5)

Clinical Study Site

Huntington Beach, California, 92647, United States

Location

Teva Clinical Study Site

Lakewood, Colorado, 80401, United States

Location

Clinical Study Site

Minneapolis, Minnesota, 55402, United States

Location

Clinical Study Site

Oklahoma City, Oklahoma, 73120, United States

Location

Clinical Study Site

Lake Oswego, Oregon, 97035, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol; Procaterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2007
• First Posted: September 17, 2007
• Study Start: July 25, 2007
• Primary Completion: October 24, 2008
• Study Completion: October 24, 2008
• Last Updated: September 7, 2022
• Results First Posted: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (5)