This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis. Participants are put into one of 2 groups randomly, which means the group is chosen by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo. Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months. Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Nerandomilast
Placebo
University of California Los Angeles
Los Angeles, California, United States
NOT_YET_RECRUITINGUniversity of Colorado Denver
Aurora, Colorado, United States
NOT_YET_RECRUITINGClinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, United States
NOT_YET_RECRUITINGUniversity of Kansas Medical Center
Kansas City, Kansas, United States
NOT_YET_RECRUITINGTime to physiologic or radiologic worsening of ILA/ILD over the whole trial
Defined as relative decline in forced vital capacity (FVC) % predicted of \>10% from baseline; or absolute decline in diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted \>10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) \>2% and total disease extent (TDE) \>2.5% on chest high resolution CT scan (HRCT), as measured by e-Lung Quantitative HRCT scoring, from baseline
Time frame: up to 164 weeks
Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104
Time frame: at baseline, at weeks 26, 52 and 104
Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104
Time frame: at baseline, at weeks 26, 52 and 104
Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104
Time frame: at baseline, at weeks 26, 52 and 104
Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104
Time frame: at baseline, at weeks 26, 52 and 104
Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial
Time frame: up to 164 weeks
Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial
Time frame: up to 164 weeks
Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial
Time frame: up to 164 weeks
Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-lung quantitative HRCT scoring over 52 weeks and over the whole trial
Time frame: up to 164 weeks
Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks
Time frame: up to 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Brigham and Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
NOT_YET_RECRUITINGWeill Cornell Medicine-New York-60569
New York, New York, United States
NOT_YET_RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
NOT_YET_RECRUITING...and 46 more locations