Phase 2
N=118
Prostaglandin Inhibition for Emphysema
Emphysema
Bottom Line
View on ClinicalTrials.gov: NCT02006576 ↗Enrolled (actual)
118
Serious AEs
5.1%
Results posted
Dec 2019
Primary outcome: Primary: Will Ibuprofen, 600 mg Three Times Daily, Decrease PGE Concentration in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? — 0.003; -0.156 Change in ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 600 mg ibuprofen three times daily for 48 weeks (Drug); Placebo three times daily (Other)
- Age
- Adult, Older Adult · 46+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Will Ibuprofen, 600 mg Three Times Daily, Decrease PGE Concentration in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? |
0.003; -0.156 | — |
| SECONDARY Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? |
-1.060; 0.011 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age > 45 years
- Emphysema (>5% of voxels 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
Data sourced from ClinicalTrials.gov (NCT02006576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.