Interstitial Lung Disease Clinical Trials

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 website:

INSTAGE BI 1199.36:  A Phase III,  24- week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib co-administered with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment.

Qualifying patients will be given nintedanib. Patients will be randomized using a 1:1 ratio to sildenafil or placebo. Treatment period will last for 24 weeks and include six visits to clinic. These visits will be spaced four weeks apart through week 1 to week 12. From week 13 to week 24, visits will be six weeks apart. A follow-up visit will be 28 days after last drug administration.

Primary Investigator: Lake Morrison, MD

PF-ILD BI 1199.247: A Phase III, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD).

To qualify for this study patients must have a diagnosis of worsening ILD, other than IPF (Idiopathic Pulmonary Fibrosis). Patients must have experienced a decline in PFTs, worsening of respiratory symptoms, and/or an increase in the extent of fibrotic changes on chest imaging. Patients will be randomized using a 2:3 ratio to placebo or nintedanib.

Treatment Period: Part A of this trial last for 52 weeks and involves nine clinic visits. These visits will be every two weeks for six weeks and every six weeks thereafter.

Variable Treatment: Part B involves continuing treatment with visits every four weeks until the last patient enrolled meets 52 weeks of treatment.

Primary Investigator: Lake Morrison, MD  

IPF-PRO BI 1199.174: Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry is a prospective registry, collecting information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life of idiopathic pulmonary fibrosis (IPF) participants, and the methods of treatment for participants with a diagnosis of IPF. Participants will not receive any medication or interventions by participating in the IPF Registry.

To qualify for this study participants must have a new diagnosis (within the last six months) of Idiopathic Pulmonary Fibrosis (IPF) at Duke. Data from the participant’s medical records will be collected every six months. Questionnaires are administered and blood samples are collected at the normally scheduled pulmonary doctor visits. Duke Clinical Research Institute will contact participants every six months to conduct a telephone interview and confirm vital status and document any hospitalizations.

Primary Investigator:  Lake Morrison, MD

PFF Registry: Pulmonary Fibrosis Foundation Patient Registry is an observational registry. This means participants will not receive any investigational treatments or drugs. Disease management and treatment decisions will be determined by the participant and the health care professional.

To qualify for this study participants must have Interstitial Lung Disease (ILD). Participants will have data abstracted from their medical records every six months. An optional biorepository study will be offered to participants, which requires a one-time blood draw, the equivalent of 30mL (two tablespoons). Participants will be followed through medical records and will be requested to complete questionnaires related to quality of life during their normally scheduled pulmonary doctor visits.

Primary Investigator: Lake Morrison, MD

 

For additional information contact Shannon D. Tilley RRT, RCP, Clinical Research Coordinator for Interstitial Lung Disease, 919-668-8854.

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. Click here for a list of current clinical trials.