Who is sponsoring NCT02006576?

NCT02006576 is sponsored by University of Nebraska.

What drugs are being tested in NCT02006576?

Interventions in NCT02006576: 600 mg ibuprofen three times daily for 48 weeks, Placebo three times daily.

Is NCT02006576 still recruiting?

NCT02006576 is currently completed. Last updated 13 December 2023.

Are results published for NCT02006576?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-12-13 · How we verify

NCT02006576: PIE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prostaglandin Inhibition for Emphysema

Completed Phase 2 Results posted Last updated 13 December 2023

What this trial tests

Phase 2 trial testing 600 mg ibuprofen three times daily for 48 weeks in Emphysema in 118 participants. Completed in 31 March 2018.

Timeline

1 January 2014

Primary endpoint
31 March 2018

31 March 2018

Quick facts

Lead sponsor	University of Nebraska
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	118
Start date	1 January 2014
Primary completion	31 March 2018
Estimated completion	31 March 2018
Sites	5 locations across United States

Drugs / interventions tested

600 mg ibuprofen three times daily for 48 weeks — full drug profile →
Placebo three times daily — full drug profile →

Conditions studied

Emphysema — all drugs for Emphysema →

Sponsor

University of Nebraska

Who can join

Adults 46 to 80, any sex, with Emphysema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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? Primary · 12 weeks after subject randomization

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.

Group	Value	95% CI
COPD, Placebo	0.003	± 0.080
COPD, Ibuprofen	-0.156	± 0.455

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? Secondary · 12 weeks after subject randomization

Pro-collagen peptide fragments will be measured by ELISA 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.

Group	Value	95% CI
COPD, Placebo	-1.060	± 8.729
COPD, Ibuprofen	0.011	± 0.584

Adverse events — posted to ClinicalTrials.gov

Time frame: Three year period from the first study visit through the last completed study visit on at 48 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

COPD, Placebo

Serious: 4/35 (11%)

Deaths: 0/35

Control Subject

Serious: 0/51 (0%)

Deaths: 0/51

COPD, Ibuprofen

Serious: 2/32 (6%)

Deaths: 1/32

Serious adverse events (4 terms)

Reaction	System	COPD, Placebo	Control Subject	COPD, Ibuprofen
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—	—
Left Chest Pain	Musculoskeletal and connective tissue disorders	—	—	—
COPD Exacerbation	Respiratory, thoracic and mediastinal disorders	—	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	COPD, Placebo	Control Subject	COPD, Ibuprofen
AECOPD	Respiratory, thoracic and mediastinal disorders	—	—	—
COPD Exacerbation	Respiratory, thoracic and mediastinal disorders	—	—	—
Headache	General disorders	—	—	—
Pneumonis	Respiratory, thoracic and mediastinal disorders	—	—	—
Positive Occult Blood	Blood and lymphatic system disorders	—	—	—
Acute Sinus Infection	Respiratory, thoracic and mediastinal disorders	—	—	—
Mild benign-appearing intrinsic stenosis	Gastrointestinal disorders	—	—	—
Left Hip Pain	Musculoskeletal and connective tissue disorders	—	—	—
Viral Gastroenteresis	Gastrointestinal disorders	—	—	—
Upper Respiratory Infection	Respiratory, thoracic and mediastinal disorders	—	—	—
Cough and Chest Congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Pneumonia, Bronchospasm, Left Chest Pain, COPD Exacerbation.

Data from ClinicalTrials.gov NCT02006576 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Emphysema

Currently open trials in the same condition.

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NCT06533371 — Clinical-ultrasonographic Assessment of Pulmonary Emphysema · NA · recruiting
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Other University of Nebraska trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02006576 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Nebraska
Last refreshed: 13 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02006576.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing