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

A clinical trial is investigating the use of inhaled Fexlamose for treating adult participants aged 40 to 80 with moderate to severe COPD. The study focuses on individuals with a verified diagnosis of cigarette smoking-related COPD and specific spirometry performance criteria.

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.
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Reference News

[1]
A Study to Investigate Using Inhaled Fexlamose to Treat Adult ...
ctv.veeva.com · Jan 1, 2025

Participants aged 40-80 with COPD due to smoking, FEV1 25-60% of predicted, stable COPD meds, ≤2 hospitalizations for CO...

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