Study on Inhaled Fexlamose for Treating Moderate to Severe COPD in Adults

Main Inclusion Criteria

Each participant must meet all the following criteria to be enrolled in this study:

• Age and Gender: Participant is male or female, aged 40 to 80 years.
• Diagnosis: Participant has a verified diagnosis of cigarette smoking-related COPD with FEV1 >25% and <60% of predicted normal at Visit 1.
• Spirometry Performance:
  • Acceptability: Participant can perform acceptable spirometry (meeting 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.
• Medication: Participant is on stable maintenance COPD medications with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.
• Exacerbations: 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.