Status:
TERMINATED
COPD Exacerbation Alert System With urinE anaLysis Using the HEADSTART Device
Lead Sponsor:
Mologic Ltd
Collaborating Sponsors:
University Hospitals, Leicester
Conditions:
COPD Exacerbation
Eligibility:
All Genders
40+ years
Brief Summary
The Headstart Test system is an in vitro diagnostic test intended for self-testing for the detection of five biomarkers of infection in the urine of patients diagnosed with chronic obstructive pulmona...
Detailed Description
Patients will be asked to collect and test a daily urine sample using a novel testing system (HeadStart Test system) in addition to answering questions abut their daily COPD symptoms for 6 months. In...
Eligibility Criteria
Inclusion
- Aged 40 years or over.
- Diagnosis of COPD Stage 2-4 (GOLD I-IV) by spirometry.
- Be a frequent exacerbator ie. ≥2 moderate exacerbations in the past 12 months.
- Current or ex-smokers with a smoking history of at least 10 pack-years.
- Be willing and able to comply with study procedures and be available for study visits
- Be able to use a 'smart phone'.
- Be able to give written consent.
- Able to understand written and spoken English. -
Exclusion
- Inability to give written informed consent
- Known respiratory disorders other than COPD which, in the opinion of the investigator, is the main contributor to patient's symptoms (e.g. asthma, lung cancer, sarcoidosis and other interstitial lung disease (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis).
- Known history of significant systemic and other organ-related disease, other than COPD, which in the opinion of 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).
- Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ).
- Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months.
- Have cancer, or other terminal condition, which, in the opinion of investigator, has a mortality of 12 months or less.
- Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
- Taking high dose oral corticosteroid medication (equivalent to daily dose of ≥10mg of prednisolone) for more than 3 consecutive months.
- Pregnancy
- 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.
- Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the IVD device, or complete the questionnaires), or at the Clinician's discretion for other more significant medical/social reasons.
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Key Trial Info
Start Date :
November 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 24 2022
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04296318
Start Date
November 19 2019
End Date
July 24 2022
Last Update
July 28 2022
Active Locations (1)
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1
Institute for Lung Health, Glenfield Hospital
Leicester, Leicestershire, United Kingdom, LE3 9QP