Description

The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.

Inclusion criteria

• Outpatient
• Male or female subjects aged ≥40 years.
• COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report
• COPD Assessment Test (CAT) score ≥10
• Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]

Exclusion criteria

• Female subjects who are pregnant
• Subjects using the following medications prior to the screening visit and during the run-in period:
  * Systemic/oral/parenteral corticosteroids in the prior 4 weeks
  * Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks
  * Oral xanthine derivatives (e.g. theophylline) in the prior 7 days
• Requirement of long term (> 15 hours daily) oxygen therapy

Clinical Trial investigator

 Dr. Jose David Suarez