Asthma
Conditions
Brief summary
This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard press-and-breathe inhaler.
Detailed description
This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.
Interventions
DRUGAlbuterol HFA-BOI
Albuterol HFA breath operated inhaler, 90 mcg/sprau
DRUGAlbuterol HFA-MDI
Albuterol HFA multi-dose inhaler
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening * Poor inhaler coordination as assessed at screening * Reversible bronchoconstriction (≥ 12% increase in FEV1)
Exclusion criteria
* Albuterol allergy * Investigational drug within 30 days * Injected corticosteroid within 6 weeks * Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled * Other criterial apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs) | Pre-dose and +120 minutes |
Secondary
| Measure | Time frame |
|---|---|
| The area-under-the-effect curve of change in SGaw from basline over time | Pre-dose and +120 minutes |
| The maximum increase in SGaw from baseline over two hours | Baseline through +120 minutes |
| Time in hours to the maximum increase in SGaw from baseline | Baseline through +120 minutes post-dose |
Countries
United States
Outcome results
None listed