Phase 4
Completed N=49
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
Source: ClinicalTrials.gov NCT00530062 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: 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 — 21.403; 20.457 percent change from baseline*hour — p=0.5595
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
21.403; 20.457 | 0.5595 |
| SECONDARY Percent Change From Baseline in FEV1 Within 30 Minutes Postdose |
10.777; 10.114 | — |
| SECONDARY Percent Change From Baseline in FEV1 up to 2 Hours Postdose |
14.319; 13.731 | — |
| SECONDARY Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2 |
0.443; 0.407 | — |
| SECONDARY Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose |
57.1; 42.9 | — |
| SECONDARY Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose |
32.7; 30.6 | — |
| SECONDARY Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose |
60.00; NA | — |
| SECONDARY Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose |
NA; NA | — |
| SECONDARY Time to Maximum Increase in FEV1 |
48.00; 45.00 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00530062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.