Brief Summary:
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.
Detailed Description:
This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally.
Age target 12 – 80 years old
To be eligible you must have (Not a full list of requirments)
No other asthma med other than
Must not be a current smoker
Former smokers must have stopped <6m prior to visit 1 (tobacco, e-cigarettes).
A standard trial proceeds forward in several phases:
- A screening visit: During this visit, an informed consent document is reviewed with you, as well as your Medical History by the Investigational Staff.
- A baseline visit: When you attend this visit (the first step in your trial) you’ll receive your study medication, and the dosing will be reviewed with you. (This visit may be combined with the screening visit).
- Routine study visits These are periodic visits done throughout the study to track an individual’s progress during a clinical trial. The study team may:
- Test bloodwork
- Administer the study drug
- Perform a checkup on your condition.
Personal lifestyle changes or restrictions during a clinical study depend on the protocol and the treatment in question. In some cases, some treatments may have more restrictions than others.
Complete >70% e-dairies
No caffeine or xanthine-contained products, coffee, tea, cola drinks or chocolate 6h before of each visit.
No tobacco product or vaping 6m prior V1 and until 1m after final visit
Abstain from consuming any intoxicants within 24h before spirometry.