COPD Exacerbation Alert System With urinE anaLysis Using the HEADSTART Device (COPE-WEL)

Protocol for COPE-WEL Observational Validation Trial COPD Exacerbation Alert System With urinE anaLysis - Clinical Validation of the Headstart® Test System for Early Detection of Exacerbations in Moderate/Severe COPD Patients

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.

Study Overview

• Status: Terminated
• Conditions: COPD Exacerbation

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 summary, this study aims to validate a novel non-invasive point of care (near-patient) testing system, to allow people with COPD to detect pulmonary exacerbations by measuring urinary biomarkers. If successful, we hope that this will provide patients with an easy to use device, which will empower patients and their caregivers to treat exacerbations at an earlier stage, with potential health and economic benefits.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE3 9QP
      • Institute for Lung Health, Glenfield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

1. Aged 40 years or over.
2. Diagnosis of COPD Stage 2-4 (GOLD I-IV) by spirometry.
3. Be a frequent exacerbator ie. ≥2 moderate exacerbations in the past 12 months.
4. Current or ex-smokers with a smoking history of at least 10 pack-years.
5. Be willing and able to comply with study procedures and be available for study visits
6. Be able to use a 'smart phone'.
7. Be able to give written consent.
8. Able to understand written and spoken English. -

Exclusion Criteria:

1. Inability to give written informed consent
2. 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).
3. 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).
4. Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ).
5. Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months.
6. Have cancer, or other terminal condition, which, in the opinion of investigator, has a mortality of 12 months or less.
7. Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
8. Taking high dose oral corticosteroid medication (equivalent to daily dose of ≥10mg of prednisolone) for more than 3 consecutive months.
9. Pregnancy
10. 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.

11. 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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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mologic Ltd
• Collaborators: University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): July 24, 2022

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Headstart COPE-WEL MSR030/046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No