Phase
Condition
Lung Injury
Cystic Fibrosis
Scar Tissue
Treatment
A wearable cough monitoring device, the Strados Labs RESPᵀᴹ sensor, with an accompanying mobile application (App) for data collection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria
Provision of signed informed consent in writing prior to study data collection
Subject aged 18 years or over
Subject diagnosed with Non-Idiopathic Pulmonary Fibrosis (IPF) Pulmonary Fibrosis (>10% fibrosis on High Resolution Computed Tomography (HRCT) by principal investigator assessment) or IPF as per American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Asociación Latinoamericana de Tórax (ATS/ERS/JRS/ALAT) Guidelines within the past 12 months
Forced Vital Capacity (FVC) > 40% predicted at baseline visit
Life expectancy > 6 months (per assessment of treating physician)
Exclusion criteria
Current smokers
Upper Respiratory Tract Infection (URI) or Lower Respiratory Tract Infection (LRTI, including Coronavirus Disease (COVID)-19 infection) within 4 weeks of screening visit
Airflow obstruction (Forced expiratory volume in one second (FEV1)/FVC < 70%) at baseline or known history of significant spirometry response to bronchodilator
Cough due to etiology other than Interstitial Lung Disease (ILD) (e.g., allergic rhinitis, Gastroesophageal Reflux Disease (GERD))
Other respiratory disorders including, but not limited to, a current diagnosis of any obstructive disease including chronic obstructive pulmonary disease (COPD) and asthma, active tuberculosis, lung cancer in treatment or in medical history, sleep apnea, known alpha-1 antitrypsin deficiency, cor pulmonale, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary diseases.
Initiation or change in dose or type of anti-tussive medication, angiotensin-converting enzyme (ACE) inhibitors, opiates, and systemic or inhaled (excluding intranasal) corticosteroids in the 4 weeks prior to study entry
Subject with ILD exacerbation as defined by investigators within 4 weeks prior to study entry
Subject participating in a clinical study of a systemic or inhaled drug at the time of enrollment
further exclusion criteria apply
Study Design
Connect with a study center
Aalst - HOSP Onze-Lieve-Vrouw
Aalst, 9300
BelgiumSite Not Available
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
BelgiumSite Not Available
Kortrijk - HOSP AZ Groeninge Kennedylaan
Kortrijk, 8500
BelgiumSite Not Available
Roeselare - HOSP AZ Delta
Roeselare, 8800
BelgiumSite Not Available
Universitätsklinikum Freiburg
Freiburg, 79106
GermanySite Not Available
Universitätsklinikum Jena
Jena, 07747
GermanySite Not Available
Rijnstate Hospital
Arnhem, 6815 AD
NetherlandsSite Not Available
Amphia Ziekenhuis
Breda, 4818 CK
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, 3015 CP
NetherlandsSite Not Available
Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado 80228
United StatesSite Not Available
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida 33470
United StatesSite Not Available
Renown Regional Medical Center
Reno, Nevada 89502
United StatesSite Not Available
Lenox Hill Hospital
New York, New York 10021
United StatesSite Not Available
Southeastern Research Center
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Lowcountry Lung and Critical Care
Charleston, South Carolina 29406
United StatesSite Not Available
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