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CompletedNCT00530062Updated Sep 7, 2022Results posted

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

A Phase 4 interventional study of Albuterol-HFA-MDI and Albuterol-HFA-BAI in Asthma, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 5 sites in United States. Open to participants aged 7 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-07.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
7 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma and Poor Coordinators of Asthma Inhalers
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 49 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugAlbuterol-HFA-MDI

    Inhalation Aerosols, 90 mcg, 1 dose per treatment period

    Also known as: Albuterol, ProAir

  • DrugAlbuterol-HFA-BAI

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

    Also known as: Albuterol

06

What researchers measure

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.

    Time frame: Baseline, Up to 2 hours postdose

Secondary outcomes

  1. 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.

    Time frame: Baseline up to 30 minutes postdose

  2. 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.

    Time frame: Baseline up to 2 hours postdose

  3. 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.

    Time frame: Baseline up to 2 hours postdose

  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

    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

  7. 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 frame: Baseline up to 2 hours postdose

  8. 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.

    Time frame: Baseline up to 2 hours postdose

07

Results

Posted Aug 31, 2022

Participant flow

Participant flow — Overall Study
MilestoneOverall Population
Started49
Received at least 1 dose of study drug49
Completed49
Not completed0

Outcome measures

PrimaryArea-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.

Time frame:
Baseline, Up to 2 hours postdose
Reported as:
Mean · percent change from baseline*hour
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
percent change from baseline*hourAlbuterol-HFA-BAIAlbuterol-HFA-MDI
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 AUEC0-221.403 ± 2.26320.457 ± 2.253
Statistical analysis
  • Albuterol-HFA-BAI vs Albuterol-HFA-MDI · ANCOVA · p = 0.5595 (Threshold for significance at 0.05 level.) · Difference in adjusted mean: 0.946 · 95% CI -2.293 to 4.185
SecondaryPercent 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.

Time frame:
Baseline up to 30 minutes postdose
Reported as:
Mean · percent change
Percent Change From Baseline in FEV1 Within 30 Minutes Postdose
percent changeAlbuterol-HFA-BAIAlbuterol-HFA-MDI
Percent Change From Baseline in FEV1 Within 30 Minutes Postdose10.777 ± 1.18510.114 ± 1.180
SecondaryPercent 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.

Time frame:
Baseline up to 2 hours postdose
Reported as:
Mean · percent change
Percent Change From Baseline in FEV1 up to 2 Hours Postdose
percent changeAlbuterol-HFA-BAIAlbuterol-HFA-MDI
Percent Change From Baseline in FEV1 up to 2 Hours Postdose14.319 ± 1.29213.731 ± 1.286
SecondaryArea-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.

Time frame:
Baseline up to 2 hours postdose
Reported as:
Mean · liters*hours
Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2
liters*hoursAlbuterol-HFA-BAIAlbuterol-HFA-MDI
Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-20.443 ± 0.0440.407 ± 0.044
SecondaryPercentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
Time frame:
Baseline up to 2 hours postdose
Reported as:
Number · percentage of participants
Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
percentage of participantsAlbuterol-HFA-BAIAlbuterol-HFA-MDI
Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose57.142.9
SecondaryPercentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
Time frame:
Baseline up to 2 hours postdose
Reported as:
Number · percentage of participants
Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
percentage of participantsAlbuterol-HFA-BAIAlbuterol-HFA-MDI
Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose32.730.6
SecondaryTime 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 frame:
Baseline up to 2 hours postdose
Reported as:
Median · minutes
Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
minutesAlbuterol-HFA-BAIAlbuterol-HFA-MDI
Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose60.00 (45.00 to NA)NA (46.00 to NA)
SecondaryTime 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 frame:
Baseline up to 2 hours postdose
Reported as:
Median · minutes
Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
minutesAlbuterol-HFA-BAIAlbuterol-HFA-MDI
Time to a 15% Increase From Baseline in FEV1 Within 2 Hours PostdoseNA (123.0 to NA)NA (NA to NA)
SecondaryTime 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.

Time frame:
Baseline up to 2 hours postdose
Reported as:
Median · minutes
Time to Maximum Increase in FEV1
minutesAlbuterol-HFA-BAIAlbuterol-HFA-MDI
Time to Maximum Increase in FEV148.00 (15.00 to 123.0)45.00 (11.00 to 128.0)

Adverse events

Collected over From the day of study drug administration up to 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Albuterol-HFA-BAI0/49 (0%)0/49 (0%)0/49 (0%)
Albuterol-HFA-MDI0/49 (0%)0/49 (0%)0/49 (0%)

Baseline characteristics

Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of the assigned study medication.

Age, Continuous
Age, Continuous(years)Overall Population
Mean14.1 ± 9.59
Sex: Female, Male
Sex: Female, Male(Participants)Overall Population
Female27
Male22
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Overall Population
Hispanic or Latino11
Not Hispanic or Latino38
Unknown or Not Reported0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Overall Population
Race — Black or African heritage2
Race — White47
08

Study locations

5 sites
  • Clinical Study Site
    Huntington Beach, California 92647, United States
  • Teva Clinical Study Site
    Lakewood, Colorado 80401, United States
  • Clinical Study Site
    Minneapolis, Minnesota 55402, United States
  • Clinical Study Site
    Oklahoma City, Oklahoma 73120, United States
  • Clinical Study Site
    Lake Oswego, Oregon 97035, United States
09

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00530062
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Responsible party
Sponsor
First posted
Sep 17, 2007
Start date
Jul 25, 2007
Primary completion
Oct 24, 2008
Completion
Oct 24, 2008
Results posted
Aug 31, 2022
Last update
Sep 7, 2022

Study contacts

Teva Medical Expert, MD
study director · Teva Branded Pharmaceutical Products R&D, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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