To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
SPARC Site 02
Miami Lakes, Florida, United States
SPARC site 01
Bethesda, Maryland, United States
SPARC Site 04
St Louis, Missouri, United States
SPARC Site 06
Gastonia, North Carolina, United States
Pharmacodynamic Endpoint Post-dose PC20
The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population.
Time frame: Approximately 15 minutes after last inhalation of study product
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Treatment D
SPARC Site 05
Edmond, Oklahoma, United States
SPARC Site 07
Warwick, Rhode Island, United States
SPARC Site 08
Boerne, Texas, United States
SPARC Site 03
Waco, Texas, United States