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Completed

NCT Number: NCT00530062

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

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.

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Key information

Conditions

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

Age range

7 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Study Site, Huntington Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Albuterol-HFA-MDI

Drug

Inhalation Aerosols, 90 mcg, 1 dose per treatment period

Other names: Albuterol, ProAir

Albuterol-HFA-BAI

Drug

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

Other names: Albuterol

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

    Time frame: Baseline, Up to 2 hours postdose

    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 outcomes

  1. Percent Change From Baseline in FEV1 Within 30 Minutes Postdose

    Time frame: Baseline up to 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.

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

    Time frame: Baseline 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.

  3. Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2

    Time frame: Baseline up to 2 hours postdose

    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.

  4. Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose

    Time frame: Baseline up to 2 hours postdose

  5. Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose

    Time frame: Baseline up to 2 hours postdose

  6. Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose

    Time frame: Baseline up to 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.

  7. Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose

    Time frame: Baseline up to 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.

  8. Time to Maximum Increase in FEV1

    Time frame: Baseline up to 2 hours postdose

    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.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 17, 2007
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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