Scientists in the Duke Division of Pulmonary, Allergy, and Critical Care Medicine are striving to improve our understanding of the molecular mechanisms leading to interstitial lung disease (ILD).

Currently, Duke is collaborating on research to investigate the biologic and genetic basis of idiopathic pulmonary fibrosis. The ILD Clinic at Duke is participating in several multi-center clinical trials to test new and promising medications for treatment of IPF.

Current Clinical Trials

Each study has specific pulmonary function, radiographic, pathologic, and disease history requirements. A surgical lung biopsy is often not required.

Inclusion criteria vary among the studies, but all require a confident diagnosis of IPF (rather than other interstitial lung diseases, such as those associated with connective tissue disorders).

Similarly, exclusion criteria vary among studies. Of particular relevance, a significant amount of either radiographic emphysema or frank airways’ obstruction will preclude patients from participating.

Select a trial to read the full description on the ClinicalTrials.gov Web site:

BIBF 1120 (Boehringer Ingelheim)
A phase III, 52-week, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of a triple tyrosine kinase inhibitor on annual FVC decline.
— Primary Investigator: Lake Morrison, MD

ASCEND (InterMune)
A Phase III, randomized, double-blind, placebo-controlled study of the efficacy and safety of Pirfenidone.
Patients will be randomized in a 1:1 ratio to receive either pirfenidone or placebo for 52 weeks. Patients who are compliant with study treatment dosing will be permitted to enter an open-label rollover study (in which all patients will receive pirfenidone).
— Primary Investigator: Lake Morrison, MD

QAX 576 (Novartis)
A Phase II, randomized, double-blind, placebo-controlled, multiple-dose, exploratory proof of concept study to assess the safety, tolerability, efficacy, pharmacodynamics, and pharmacokinetics of an IL-13 receptor antagonist in patients with IPF. Patients will be randomized in a 3:1 ratio with IV infusions every four weeks. Each patient is expected to spend up to 56 weeks in the study.
— Primary Investigator: Eric Meltzer, MD

PANTHER (IPFnet)
This 60-week study is a multi-center, randomized, double-blind, placebo-controlled trial sponsored by the IPF net. The treatment regimen is N-acetylcysteine (600 mg TID) or placebo, in a 1:1 ratio. A third arm with N-acetylcysteine, azathioprine, and prednisone was stopped early.
— Primary Investigator: Lake Morrison, MD

CC-930-IPF-001 (Celgene)
Phase II, sequential, ascending-dose study to characterize the safety, tolerability, pharmacokinetic and biological activity of a JNK-inhibitor in patients with IPF. The study drug will be administered in two phases: a 4-week blinded phase followed by a 52-week open-label phase.
— Primary Investigato: Lake Morrison, MD

PRM-151 (Promedior)
A Phase I, randomized, double-masked, sponsor-unmasked, ascending multiple dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of a recombinant serum amyloid P component, deficiencies of which have been associated with progressive fibrosis. Each subject will participate in the study for approximately 13 weeks.
— Primary Investigator: Lake Morrison, MD

For additional information contact Marguerite Thoma, Clinical Trial Associate, at (919) 668-4562.
 

Enroll in a Pulmonary Clinical Trial at Duke

Researchers in our division are investigating a variety of treatments and therapies to respond to lung disease. For a list of current pulmonary-related clinical trials, visit DukeHealth.org.