A Study to Assess the Effectiveness and Safety of PT009 Compared to PT005 for the Prevention of Moderate to Severe Episodes of Worsening COPD

Overview

About this study

The purpose of this study is to assess the safety and effectiveness of  PT009 compared with PT005 for the prevention of moderate to very severe episodes of worsening COPD and lung function.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Signed written informed consent to participate
  • At least 40 and no older than 80 years of age
  • COPD patients who are symptomatic
  • Must be receiving one or more inhaled bronchodilators as maintenance therapy
  • Must have a documented history of COPD exacerbations

Exclusion Criteria

  • Current diagnosis of asthma
  • COPD due to α1-antitrypsin deficiency
  • Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
  • Long-term-oxygen therapy ≥ 15 hours a day

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Paul Scanlon, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20257591

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