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Nonsteroidal Anti-inflammatory Drug

COPD, ibuprofen for Emphysema (PIE Trial)

Phase 2
Waitlist Available
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 years from initial fev1 assessment
Awards & highlights

PIE Trial 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.

Eligible Conditions
  • Emphysema

PIE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 years from initial fev1 assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 years from initial fev1 assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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?
Secondary outcome measures
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?
Other outcome measures
Are Levels of 6kPGF1a (the Primary Metabolite of Prostacyclin) Increased in the Alveolar Component of BAL Fluid in Patients With COPD? Are the Levels Related to FEV1 and/or Severity of Emphysema?
Are Levels of PGD Increased in the Alveolar Component of BAL Fluid in Patients With COPD? Are Levels of PGD in Alveolar Lavage Fluid Related to FEV1 and/or Severity of Emphysema?
Are Levels of TXB2 (the Primary Metabolite of Thromboxane) Increased in the Alveolar Component of BAL Fluid in Patients With COPD? Are the Levels Related to FEV1 and/or Severity of Emphysema?
+29 more

Side effects data

From 2018 Phase 2 trial • 118 Patients • NCT02006576
9%
AECOPD
6%
COPD Exacerbation
3%
Cough and Chest Congestion
3%
Positive Occult Blood
3%
Headache
3%
Acute Sinus Infection
3%
Left Hip Pain
3%
Viral Gastroenteresis
3%
Upper Respiratory Infection
3%
Mild benign-appearing intrinsic stenosis
3%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
COPD, Ibuprofen
COPD, Placebo
Control Subject

PIE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: COPD, ibuprofenExperimental Treatment1 Intervention
600 mg ibuprofen three times daily for 48 weeks
Group II: Control subjectActive Control1 Intervention
Control subjects, no intervention
Group III: COPD, PlaceboPlacebo Group1 Intervention
Placebo three times daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
FDA approved

Find a Location

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,538 Previous Clinical Trials
10,266,912 Total Patients Enrolled
6 Trials studying Emphysema
3,457 Patients Enrolled for Emphysema
National Jewish HealthOTHER
141 Previous Clinical Trials
315,985 Total Patients Enrolled
3 Trials studying Emphysema
3,047 Patients Enrolled for Emphysema
University of Alabama at BirminghamOTHER
1,597 Previous Clinical Trials
2,284,010 Total Patients Enrolled
3 Trials studying Emphysema
3,061 Patients Enrolled for Emphysema
~10 spots leftby Jun 2025
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