The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, 5-Treatment, Randomized, Crossover Study to Demonstrate the Pharmacodynamic Bioequivalence of Test and Reference Metered Dose Inhalers containing Albuterol Sulfate using Bronchoprovocation in Adult Patients with Stable Mild Asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
217
Investigational Research Center Site #110
Huntington Beach, California, United States
Investigational Research Center Site #114
Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo
The primary efficacy endpoint was the postdose PC20 following administration of differing doses of albuterol (or placebo) by inhalation. The 20% reduction in FEV1 was determined relative to the saline stage FEV1 measured before albuterol or placebo administration. Additionally, an analysis of superiority to placebo was performed for the T and R products prior to the BE determination. In this study the ITT and PP populations were identical.
Time frame: Post-dose at Visits 2-6 of the study, a total of approximately 4 weeks.
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Mission Viejo, California, United States
Investigational Research Center Site #113
Rolling Hills Estates, California, United States
Investigational Research Center Site #112
San Diego, California, United States
Investigational Research Center Site #116
San Jose, California, United States
Investigational Research Center Site #106
Tallahassee, Florida, United States
Investigational Research Center Site #109
Baltimore, Maryland, United States
Investigational Research Center Site #105
Bethesda, Maryland, United States
Investigational Research Center Site #103
North Dartmouth, Massachusetts, United States
Investigational Research Center Site #108
St Louis, Missouri, United States
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