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Nonsteroidal Anti-inflammatory Drug

COPD, ibuprofen for CPFE Syndrome (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
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial tests if taking ibuprofen regularly can help patients with emphysema by blocking a substance that hinders lung repair. The goal is to see if this common pain reliever can improve lung function where other treatments have failed. Ibuprofen has shown beneficial effects on lung function in children with mild to moderate lung disease and has a favorable safety profile.

Eligible Conditions
  • CPFE Syndrome
  • Emphysema

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 study objectives
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%
Positive Occult Blood
3%
Cough and Chest Congestion
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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
1,564 Previous Clinical Trials
10,262,515 Total Patients Enrolled
National Jewish HealthOTHER
144 Previous Clinical Trials
317,282 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,646 Previous Clinical Trials
2,342,655 Total Patients Enrolled
~10 spots leftby Nov 2025
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