KALOS – A variable length efficacy & safety study to assess an inhaled, fixed-dose, triple-combination of Budesonide/ Glycopyrronium/ Formoterol Fumarate in adults with poorly controlled asthma
This study is designed to check the safety and effectiveness of a 3 drug inhaler for people who do not have good asthma control. The study will compare two different doses of the 3 drug inhaler against a similar 3 drug combination. The study participants will be involved for up to 64 weeks.
About the study
Principal investigator
Dr. Del Dorscheid
Associate Professor
Area(s) of medical focus
Breathing & Lung
Condition(s)
Asthma
Period of enrollment
2021-12-21 - 2024-08-23
Participating sites
St. Paul's Hospital
Purpose of trial
This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study. The purpose of this study is to evaluate the efficacy and safety of BGF MDI (Budesodine/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler) 320/28.8/9.6 μg twice daily, compared with Budesonide and Formoterol Fumarate MDI 320/9.6 μg, (BFF MDI), twice daily and Symbicort® pressurized metered-dose inhaler (pMDI) 320/9 μg (Symbicort), twice daily, over a variable length treatment period, between 24 weeks and 52 weeks.
Eligibility
- Participants must be 19 to 80 years old, at the time of signing the consent form
- They must have a documented history of doctor-diagnosed asthma ≥1 year prior to Visit 1
- They must have been regularly using a stable daily dose of ICS/LABA medication for at least 4 weeks prior to Visit 1
- They must be willing to change their current asthma therapy
- They must be able to perform lung function tests and they must meet the study criteria
- Other criteria will be discussed
Contact information
Shoshana Parker
Researcher
Co-Investigators
Dr. Janice Leung
Dr. Clarus Leung
Additional Information
Study Phase
Phase 3
Study Type
Drug