clinical trial · NCT05322707
BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient
AsthmaBudesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μgSymbicort, 80 Mcg-4.5 Mcg/Inh Inhalation AerosolPlacebo
brief summary
The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma
started
Apr 15, 2022
primary completion
Aug 15, 2023
completion
Aug 29, 2023
last updated
Aug 30, 2023
detailed description
This study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measures at different timepoints in adult patient with Asthma.
official title
Multicenter Randomized Parallel-Group 6-Week Treatment Clinical Study to Assess BE of Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Comparison With Reference Product, Symbicort® in Adult Asthma Patients
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol