A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD

A regiszterben nem jelölt feltételek

• Main Inclusion Criteria
• Each participant must meet all the following criteria to be enrolled in this study:
• Participant is male or female ≥40 to ≤80 years of age.
• Participant has a verified diagnosis of cigarette smoking-related COPD FEV1 that is >25% and <60% of predicted normal at Visit 1.
• Participant meets the following spirometry performance criteria:
  • Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2.
  • Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during at least 1 of the prebronchodilator assessments at Visits 1 and 2.
• Participant is on stable maintenance COPD medications with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.
• Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year.
  • Main Exclusion Criteria
  • Participants meeting any of the following criteria will be excluded from the study:
• Participant has an active uncontrolled medical condition
• Participant has a diagnosis of current asthma
• Participant has primary diagnosis of bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF.
• Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1
• Participant has active lung infection
• Participant has received any vaccine within 7 days prior to Day 1.
• Participant is taking a protein therapeutic for control of COPD or asthma: eg, dupilumab, tezepelumab, benralizumab, mepolizumab, omalizumab.