Prostaglandin Inhibition for Emphysema

• Status: Completed
• Trial end date: 2018-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The Prostaglandin Inhibition for Emphysema (PIE) study will determine if a currently available therapy, ibuprofen 600 mg three times daily, can block PGE production in the lower respiratory tract and if this results in improvement in measures of lung repair function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nebraska
• Collaborators: National Jewish Health; Temple University; University of Alabama at Birmingham; University of California, Los Angeles
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• Age > 45 years

• Emphysema (>5% of voxels <950 Hounsfield Units determined on the CT scan performed as part of the COPDGene study as quantified at the COPDGene radiology center). An equivalent scan as determined by the radiology center is also acceptable.

• Post-bronchodilator FEV1 > 35% predicted)

• Smoker or ex-smoker (10 pack years minimum)

Exclusion Criteria:

• Contraindication to bronchoscopy or other study procedures

• Pregnancy of plans to become pregnant within six months

• Aspirin-sensitive asthma

• Regular use of systemic glucocorticoid

• Regular use of an NSAID (low dose aspirin for cardiac disease is acceptable and subjects taking only this regularly will be eligible)

• Unstable medical condition

• History of myocardial infarction or unstable angina within six months

• Allergy to or history of adverse effect from ibuprofen or other NSAID

• History of gastrointestinal bleeding within one year

• Any condition that, in the opinion of the investigator, places the subject at untoward risk

• Inability to provide informed consent