A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma

Confirmed or suspected diagnosis of COPD or clinically significant non-asthma airway/lung disease.

Systemic corticosteroid use (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for any respiratory, immune, or allergy-attributed disease within 6 months prior to Visit 1.

An upper respiratory infection requiring antibiotic treatment that is not resolved within 7 days prior to Visit 1.

A lower respiratory infection in the 4 weeks prior to Visit 1.

Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, positive pressure ventilation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1.

Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for asthma within 6 months prior to Visit 1.

A severe asthma exacerbation during the run-in period

An ePRO device alert during the run-in period with investigator-confirmed worsening asthma symptoms

Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease) disorders. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or that could affect the efficacy or safety analyses if the disease/condition exacerbated during the study.

Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1

Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1.

Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse at any time during the study.

What this study is about