NCT05322707

BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,485 (actual)
• Sponsor: Cipla Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg	Inhalation aerosol, 2 actuations orally inhaled twice daily
DRUG	Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol	Inhalation aerosol, 2 actuations orally inhaled twice daily
DRUG	Placebo	Inhalation aerosol, 2 actuations orally inhaled twice daily

Timeline

• Start date: 2022-04-15
• Primary completion: 2023-08-15
• Completion: 2023-08-29
• First posted: 2022-04-12
• Last updated: 2023-08-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study