Boehringer Ingelheim is launching a new study to better understand coughing in adults with idiopathic pulmonary fibrosis (IPF) as well as other forms of pulmonary fibrosis. The study, which is not yet recruiting, will involve patients wearing a cough monitoring device called the Strados Remote Electronic Stethoscope Platform (RESP).
The RESP device measures the frequency and strength of coughing over 24 hours in patients with pulmonary fibrosis. Data are collected using an accompanying mobile application.
The interventional pilot study will enroll approximately 50 adult participants diagnosed with IPF or non-IPF pulmonary fibrosis for 12 weeks. Patients who smoke or have upper respiratory tract infections, airflow obstruction, or cough due to other lung diseases will be excluded.
Read more about IPF comorbidities
IPF is a rare, chronic, progressive condition characterized by the buildup of fibrotic tissue in the lungs. It occurs mainly in individuals over 60 years of age and has a median survival of 3 to 4 years after diagnosis. The 2 main symptoms of IPF are dyspnea and chronic, unproductive cough. Two antifibrotic drugs have been approved for IPF treatment, but there is currently no cure for the disease.
The new study’s primary outcome measures include cough count per hour over 24 hours, measured at baseline and at weeks 4, 8, and 12. Secondary outcome measures include changes in cough count per hour at each time point, forced vital capacity (FVC) at baseline and at week 12, changes in FVC (mL) at week 12, percentage of analyzable data per day, and feasibility, as measured by the number of successful completions of the study elements.
The study’s expected start date is January 16, 2023, and the estimated completion date is September 17, 2023.
A study in people with pulmonary fibrosis to monitor cough with a wearable device. ClinicalTrials.gov. January 4, 2023. Updated January 10, 2023. Accessed January 12, 2023.