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NCT06419062Enrolling by invitation

The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 2

The Use of Medical Devices to Monitor COPD Patients Study - An Observational Feasibility Study

Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
30 (estimated)
First submitted
28 Aug 2023
Start date
3 Jul 2024
Primary completion date
1 Apr 2026
Lead sponsor
University of Strathclyde
Diseases
COPD
NCT number
NCT06419062

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 3 Jul 2024 to the primary completion date, 1 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months.
  • Taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months.
  • Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life.
  • On long-term oxygen therapy.
  • Acute exacerbation of COPD within 6 weeks prior to inclusion.

Other illness

  • Known respiratory disorders are other than COPD which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis).
  • Known history of significant systemic and other organ-related diseases, other than COPD, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders).
  • Have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
  • Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons.
  • Known allergy to strap.

Other

  • Inability to give written informed consent.
  • Known to be severely alpha-1-antitrypsin deficient (PI, SZ or ZZ).
  • Based on their medical record if there is any social violence/substance misuse.
  • Pregnancy
  • Patients already involved in an ongoing research study.

Who the study is looking for

  • Any person aged 18 years or over.
  • Current diagnosis of COPD.
  • Be willing and able to comply with study procedures and be available for study visits. • Be able to use a 'smartphone or computer'.
  • Be able to give written consent.
  • Able to understand written and spoken English.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oakview Medical Practice in Alexandria
Coordinator of this site? Confirm its status
GlasgowUnited KingdomUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.