At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Diagnosed with Non-IPF or IPF pulmonary fibrosis with >10% fibrosis on HRCT within past 12 months
- ✓FVC >40% predicted at baseline
- ✓Life expectancy >6 months per treating physician assessment
- ✕Current smokers
- ✕Upper or lower respiratory tract infection (including COVID-19) within 4 weeks of screening
- ✕Airflow obstruction (FEV1/FVC <70%) or known significant spirometry response to bronchodilator
- ✕Cough due to causes other than ILD (e.g., allergic rhinitis, GERD)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Longitudinal 12-week Pilot Study to Evaluate Cough Severity and Its Impact, Utilizing a Next Generation Cough Monitor, in Participants With Idiopathic Pulmonary Fibrosis (IPF) or Non IPF Pulmonary Fibrosis
In Brief
A clinical study evaluating A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection for Pulmonary Fibrosis. Completed, enrolled 53 participants across 13 sites in 4 countries.
Detailed Summary
This study is open to adults aged 18 years and older who have pulmonary fibrosis with or without a known cause (or other forms of pulmonary fibrosis). The purpose of this study is to better understand coughing in people with pulmonary fibrosis. To do this, a wearable cough monitor called Strados Remote Electronic Stethoscope Platform (RESP) is used. This device will measure how often and how forceful coughing is in people with pulmonary fibrosis. All participants in the study get the device. It is placed on their skin over the chest. Participants are in the study for 3 months. During this time, they visit the study site 2 to 3 times. 4 visits are done at the participant's home by video call with the site staff. During the study, the device measures coughing over 24 hours. This is done on 4 days. Participants fill in questionnaires about their coughing and doctors regularly check participant's lung function. A breathing test that measures how well the lungs are working is performed both in the office and during home visits. The doctors also regularly check participants' health and take note of any unwanted effects. This study will also record patients' experiences using the cough monitor and video assisted breathing tests at visits 3, 4, 5 and 6 at home.
Study Details
Timeline
Interventions
A wearable cough monitoring device, the Strados Labs Remote Electronic Stethoscope Platform (RESP)ᵀᴹ sensor, with an accompanying mobile application (App) for data collection.