Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients
Launched by BARRON ASSOCIATES, INC. · Mar 7, 2025
Trial Information
Current as of April 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial will be a conventional randomized, parallel controlled trial to evaluate the primary hypothesis that a 4-week period of using the ROAM adherence monitor and support system will result in increased adherence when compared to a control group with no adherence monitoring. The participant population will be individuals with chronic obstructive pulmonary disease (COPD), and who have been prescribed oxygen therapy for a minimum of 8 hours/day. Half of the participants will be randomly assigned to the ROAM group; the other half will comprise the control group.
All participants...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Post-Bronchodilator FEV1/FVC\<.80
- • Participants with medical history of COPD
- • Prescription for oxygen use via nasal cannula or mask at home
- • At baseline of health with no hospitalization/exacerbation within the past 6 weeks
- • Use of Continuous oxygen at baseline
- Exclusion Criteria:
- • Post -Bronchodilator FEV1/FVC ≤25%
- • Intermittent oxygen use at home
- • Inability to understand simple instructions
- • Respiratory exacerbation or infections within 6 weeks prior to screen visit
- • Not at baseline of medical health prior to screen visit
Trial Officials
Eileen Krepkovich, MS
Principal Investigator
Barron Associates
About Barron Associates, Inc.
Barron Associates, Inc. is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a commitment to excellence, the company specializes in the design, management, and execution of clinical trials across various therapeutic areas. Leveraging a team of experienced professionals and state-of-the-art technology, Barron Associates focuses on enhancing patient outcomes and ensuring regulatory compliance throughout the research process. Their collaborative approach fosters strong partnerships with healthcare providers, regulatory bodies, and research institutions, ultimately driving the development of safe and effective medical solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlottesville, Virginia, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported