COPD ExacerbationCOPE-WELNCT04296318
COPD Exacerbation Alert System With urinE anaLysis Using the HEADSTART Device
An observational study of COPD Exacerbation, run by Mologic Ltd at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Nov 2019to 24 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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. -
Who cannot join
- 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.
Show all 12Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute for Lung Health, Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD Exacerbation
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start19 Nov 2019
- Primary completion15 Feb 2022
- Study completion24 Jul 2022
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mologic Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296318
- Sponsor's protocol ID
- Headstart COPE-WEL MSR030/046
- Acronym
- COPE-WEL
- Status last verified
- Jul 2022
- First submitted
- 3 Mar 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04296318
- Acronym / sponsor ID
- COPE-WEL / Headstart COPE-WEL MSR030/046
- Conditions
- COPD Exacerbation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mologic LtdIndustry (pharma, biotech, devices)
- Collaborators
- University Hospitals, Leicester
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 24 Jul 2022 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Headstart IVD performance
Time frame: 6 months
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).
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Mologic Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headstart IVD performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.