Do you suffer from inadequately controlled Asthma?
This clinical research study is looking at the safety and effectiveness of an medication for people with persistent asthma. Asthma is a condition in which your airways narrow and swell and may produce extra mucus. This can make breathing difficult and trigger coughing, a whistling sound (wheezing) when you breathe out and shortness of breath.
Would you like to contribute to medical research?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your asthma to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with asthma, and whether it will be made widely available to all patients with asthma. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are between the ages of 12 to 80 years
- Have a BMI <40 kg/m2
- Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines [GINA 2020]. Healthcare records for 1 year prior to Visit 1 must be provided for adolescent participants (12 to < 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants
- Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit 1
- Demonstrate acceptable MDI administration technique
- eDiary compliance ≥ 70% during screening, defined as completing the daily eDiary and answering “Yes” to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization
You may not qualify to participate if you:
- Have life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s)
- Have any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period
- Hospitalization for asthma within 8 weeks of Visit 1
- Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary
- Known history of drug or alcohol abuse within 12 months of Visit 1
- Use of a nebulizer or a home nebulizer for receiving asthma medications
- Are a smoker, or former smokers with > 10 pack-years history, or former smoker who stopped smoking < 6 months prior to Visit 1
- For women only – currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.