Modulation of Steroid Immunosuppression by Alveolar Efferocytosis

Completed · Not applicable

Conditions studied: Pulmonary Disease, Chronic Obstructive, Pneumonia, Bacterial

In brief

The long-term goals of this study are (a) to understand the biological underpinnings for the increased incidence of community-acquired pneumonia in patients with chronic obstructive pulmonary disease (COPD) who are treated with inhaled corticosteroids; and (b) to develop novel therapies to treated this problem using over-expression of micro-RNAs (miRNAs).

Key facts

Study ID

NCT03034642

Run by

VA Ann Arbor Healthcare System

People needed

60

Starts

2015-10-01

Expected to finish

2021-12-30

Last updated by the study team

2022-05-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion Criteria for healthy subjects without COPD:
• Age 18-80 years, inclusive
• Males or females
• Never smoker (< 100 cigarettes in lifetime)
• OR
• Current smoker (>10 pack-years) with normal spirometry
• Able to perform satisfactory spirometry
• Abe to give informed consent
• Able to complete questionnaires
• Inclusion Criteria for COPD subjects:
• Age 18-80 years, inclusive
• Males or females
• Current smoker
• (>10 pack-years) \& (≥1/2 pack/day)
• OR
• Former smoker
• (>10 pack-years) \& (>6 months of non-smoking)
• Diagnosis of COPD by ATS/ERS1 criteria
• Able to perform satisfactory spirometry
• Able to give informed consent
• Able to complete questionnaires
• 1 ATS/ERS, American Thoracic Society/European Respiratory Society.

You may not qualify if…

• Exclusion Criteria for healthy subjects without COPD:
• Unstable cardiovascular disease, including uncontrolled hypertension, CHF, angina
• Significant renal (creatinine >2.5) or hepatic dysfunction (Childs B or C)
• Mental incompetence/active psychiatric illness
• Prednisone or other immunosuppressive medications
• Participation in another interventional experimental protocol within 6 weeks
• Pregnancy
• Use of antibiotics for any reason within 42 days
• Judged to be unsuitable for bronchoscopy by PI
• Resting SaO2<93%
• FEV1 < 70% predicted
• Respiratory infections within 42 days regardless of antibiotic use
• Diagnosed COPD or Asthma
• Use of inhaled corticosteroids
• Active pulmonary tuberculosis or other serious chronic respiratory infection
• Diffuse panbronchiolitis or Cystic fibrosis
• Clinically significant bronchiectasis
• History of thoracic radiation therapy for any cause
• Other inflammatory or fibrotic lung disease
• Exclusion Criteria for COPD subjects:
• Unstable cardiovascular disease, including uncontrolled hypertension, CHF, angina
• Significant renal (creatinine >2.5) or hepatic dysfunction (Childs B or C)
• Mental incompetence/active psychiatric illness
• Prednisone or other immunosuppressive medications
• Participation in another interventional experimental protocol within 6 weeks

Where it is running

• VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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