Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF. Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF. During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
BI 1839100
Placebo
University of Alabama at Birmingham
Birmingham, Alabama, United States
Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado, United States
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, United States
The Iowa Clinic, PC
West Des Moines, Iowa, United States
Advanced Pulmonary Research
Warren, Michigan, United States
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h)
Time frame: At baseline, at week 4
IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h)
Time frame: At baseline, at week 12
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score
NRS: a single-item patient reported outcome measure to assess cough severity on a 11-point numerical rating scale ranging from 0 (no cough) to 10 (worst possible cough) with a recall period of the past 7 days. Higher scores indicate higher severity of cough.
Time frame: At baseline, at week 4
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm)
VAS: the cough severity VAS is scored according to the distance between no cough (0) and the mark set by the participant, with higher distance indicating higher severity of cough.
Time frame: At baseline, at week 4
IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h)
Time frame: At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL)
Time frame: At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score
Time frame: At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm)
Time frame: At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score
L-PF: the L-PF symptom module domain and total scores as well as the L-PF impact module total score ranges from 0 to 100, with higher scores indicating a greater impairment.
Time frame: At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score
LCQ: the total score ranges from 3 to 21. A higher score indicates better cough specific quality of life.
Time frame: At baseline, at week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Memorial Hospital Gulfport
Gulfport, Mississippi, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 89 more locations