COPD Exacerbation Alert System With urinE anaLysis Using the HEADSTART Device

NCT04296318 | Terminated

• 1 other identifier: Headstart COPE-WEL MSR030/046
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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 pulmonary disease (COPD). Patient urine testing will be conducted daily to establish a patient baseline biomarker profile and provide ongoing monitoring for changes in the biomarker profile. Headstart results will be used as an aid in monitoring and early detection of pulmonary exacerbation.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Headstart IVD performance

  To determine whether the Headstart Test system can accurately diagnose an acute exacerbation of COPD prior to the onset of a clinically confirmed event. (Defined as need for antibiotics and/or Oral Corticosteroids (OCS) and/or attendance to hospital (GOLD 2019).

  6 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients, Stage 2-4 (GOLD I-IV) by spirometry, with a history of exacerbations (≥2 moderate exacerbations in the past 12 months).

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mologic Ltd: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

Institute for Lung Health, Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: November 19, 2019
• Primary Completion: February 15, 2022
• Study Completion: July 24, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

GB (1)