This randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90 mcg base (Amneal Ireland Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in patients with stable mild asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Placebo Product
90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]
180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]
Amneal Pharmaceuticals LLC
Brookhaven, New York, United States
RECRUITINGPrimary Pharmacodynamic Endpoint Post-dose PC20
Provocative concentration of the methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of albuterol or placebo by inhalation. The 20% reduction in FEV1 will be determined relative to the post-saline FEV1 measure before the placebo or albuterol administration.
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
90 mcg Test Product - ALBUTEROL SULFATE HFA \[AMNEAL IRELAND LIMITED\]