Prostaglandin Inhibition for Emphysema

NCT02006576 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 0503-13-ET
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Emphysema

Keywords

Emphysema; Prostaglandin E; Bronchoalveolar lavage

Outcome Measures

Primary Outcomes (1)

• 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?

  PGE will be measured by HPLC in alveolar fluids obtained at randomization (week 0) and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.

  12 weeks after subject randomization

Secondary Outcomes (1)

• 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?

  12 weeks after subject randomization

Other Outcomes (32)

• Prostaglandin E Concentrations n Participants With Emphysema v in Smoking, Former Smoking and Healthy Non-smoking Controls After Ibuprofen Three Times Daily

  12 weeks after subject randomization

• Will Ibuprofen 600 mg Three Times Daily, Reduce Prostaglandin E Concentrations in the Bronchial Portion of BAL Fluid in Subjects With Emphysema Compared to Placebo?

  12 weeks after subject randomization

• Will Ibuprofen 600 mg Three Times Daily, Reduce Prostaglandin E Concentrations in Induced Sputum From Subjects With Emphysema Compared to Placebo?

  10 weeks after subject randomization

Study Arms (3)

COPD, Placebo

PLACEBO COMPARATOR

Placebo three times daily

Other: Placebo three times daily

Control subject

NO INTERVENTION

Control subjects, no intervention

COPD, ibuprofen

EXPERIMENTAL

600 mg ibuprofen three times daily for 48 weeks

Drug: 600 mg ibuprofen three times daily for 48 weeks

Interventions

600 mg ibuprofen three times daily for 48 weeks DRUG

Also known as: Advil, Children's Ibuprofen, Advil Migraine, Motrin IB, NeoProfen, Caldolor, Wal-Profen, I-Prin

COPD, ibuprofen

Placebo three times daily OTHER

COPD, Placebo

Eligibility Criteria

• Age: 46 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Jewish Health: collaborator
• Temple University: collaborator
• University of California, Los Angeles: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Univerisity of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Emphysema

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Amy Nelson
• Organization: University of Nebraska Medical Center

amyjnelson@unmc.edu

402-559-5536

Study Officials

• Stephen I Rennard, MD

  University of Nebraska

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2014
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: December 13, 2023
• Results First Posted: December 16, 2019

Record last verified: 2023-11

Locations

US (5)