Study on Home Obstructive Respiratory Exacerbations

Launched by STRADOS LABS, INC. · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Strados RESP Biosensor, designed to monitor lung sounds in people with Chronic Obstructive Pulmonary Disease (COPD). The goal is to see how the information collected by this biosensor relates to patients' breathing symptoms and overall lung function when they are at home. Many patients experience COPD flare-ups that lead to hospital readmissions, so this study aims to improve care and monitoring after they leave the hospital.

To participate, individuals must be between 40 and 80 years old, have been diagnosed with COPD, and experienced at least two moderate or one severe flare-up in the past six months. Participants should also have been discharged from the hospital for at least 30 days and must be able to use a smartphone and attend study visits as needed. If you join the study, you'll use the biosensor at home and provide information about your symptoms, which will help researchers understand how well this device works for monitoring your condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females between the ages of 40 and 80 with documented physician-diagnosed COPD and FEV1/FVC\<0.70 or LLN based on post-bronchodilator spirometry
• • 2. History of 2 moderate COPD exacerbations and/or 1 severe COPD exacerbation within the past 6 months
• • 3. At least 30 days since hospital discharge from COPD exacerbation
• • 4. 6-month risk of 20% for moderate exacerbation and 7.5% for severe exacerbation based on ACCEPT score (with possibility of changing to 15% for moderate exacerbation and 5% for severe exacerbation if enrollment is insufficient)
• • 5. Tobacco History: Current or Former Smoker
• • 1. Has smoked at least 100 cigarettes in his/her lifetime 6. Patient can follow study procedures, including instructions for self-placement and operation of biosensor
• • 1. Patient has experience/owns a smartphone 7. Patient is accessible by telehealth/telephone for duration of the study 8. Patient is able and willing to return to study site for study visits as necessary
• Exclusion Criteria:
• • 1. Patient is unable or unwilling to provide informed consent
• • 2. Any condition that, in the opinion of the investigator, would limit the patient's activity in the study and/or adequate lung sound capture using the RESP™ wearable device
• • 3. Patient with end-stage medical condition with expected survival no more than 6 months
• • 4. History of adverse reaction or allergy to adhesives such as TegaDerm®