Condition category
Respiratory
Date applied
30/01/2017
Date assigned
31/01/2017
Last edited
09/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is a condition which affects the lungs and is often caused by smoking. It is characterised by breathlessness, cough and excess mucus production. COPD is commonly managed in primary care using inhaled medication, including inhaled corticosteroids (ICS). ICS treatment is recommended by NICE guidelines for worsening symptoms or moderate/severe COPD; however their use can be associated with side-effects such as pneumonia. Previous research suggests that patients with COPD vary in terms of markers (natural chemical indicators) of inflammation in their blood and breath, and this can affect disease outcomes. One of these markers is the blood eosinophil count (a type of white blood cell); another is a breath test called fraction of exhaled nitric oxide (FeNO) which measures airway inflammation. Further analysis of previous trials of ICS has found that broadly there is a greater response to ICS-containing medications in patients who have high blood eosinophil levels before treatment. The aim of this study is to gather preliminary information to look at whether blood and breath tests could be used to predict which patients would most benefit from ICS treatment, and it might be particularly useful to do this if results could be available immediately (near-patient testing).

Who can participate?
Adults aged 40 years and over who have COPD.

What does the study involve?
Participants are invited to attend an initial appointment in the research clinic at their GP surgery (approximately one hour) followed by three further visits (approximately 45 minutes) every two months over a total of six months (four appointments in total). At these appointments, they are asked questions about their COPD and medical history. They are also asked to complete some questionnaires about how good or bad their symptoms have been recently. A small clip is placed on the finger to measure oxygen levels, and height and weight are measured. Lung function tests (spirometry) are performed which test how well participants breathe in and out, both before and after using their reliever inhaler. Exhaled nitric oxide (FeNO) which is another breathing test, is also measured. Participants have a fingerprick blood test to measure the number and different types of white cells in the blood (eosinophils). A sample of blood is taken from a vein (a ‘normal’ blood test) – 3 small bottles (15ml of blood, or about 3 teaspoons) in total each appointment. At the final appointment, participants are asked to complete a short questionnaire survey about their experience of having the tests above.

What are the possible benefits and risks of participating?
There are no direct benefits of taking part however it is hoped that this study will benefit patients with COPD in future by providing information about whether these tests can help guide whether steroid inhalers are beneficial for individual patients. This study is observational, which means that no treatments are being changed as part of the study, only additional tests. There are no anticipated serious risks from doing these tests. Taking blood samples may be uncomfortable and occasionally is associated with bruising or feeling faint. Breathing tests may require additional effort but should not be painful or uncomfortable. Testing will be done by a nurse or doctor trained in these procedures.

Where is the study run from?
Six primary care practices in the Oxfordshire area (UK)

When is the study starting and how long is it expected to run for?
January 2016 to December 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Helen Ashdown
comet@phc.ox.ac.uk

Trial website

https://www.phc.ox.ac.uk/phctrials/trial-portfolio/comet

Contact information

Type

Public

Primary contact

Dr Helen Ashdown

ORCID ID

http://orcid.org/0000-0002-7758-7095

Contact details

Nuffield Dept of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
+44 1865 617868
comet@phc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32551

Study information

Scientific title

Near-patient testing to guide COPD MaintenancE Treatment in primary care (COMET): observational study to determine variability and accuracy of inflammatory biomarkers in stable state

Acronym

COMET

Study hypothesis

The aim of the study is to investigate how various markers and tests might be helpful in establishing which patients with COPD in primary care would most benefit from treatment with steroid inhalers, particularly looking at how these tests vary within and between patients, their feasibility, and how accurate near-patient tests are compared to laboratory tests.

Ethics approval

South East Scotland Research Ethics Committee 02, 18/08/2016, ref: 16/SS/0135

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Primary Care, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Chronic lower respiratory diseases

Intervention

Eligible participants will receive a letter from their GP inviting them to take part in the study, and return a reply form to the study team. They will have four appointments, at which details of their medical and COPD history will be taken, and measurements including respiratory questionnaires, height, weight, oxygen saturations, fraction of exhaled nitric oxide, spirometry and a venous blood sample for blood eosinophils, CRP and periostin, and a fingerprick sample for blood eosinophils. These four appointments will be two months apart over a six month follow-up period.

The same measurements above will be taken at each of the four appointments. At the fourth appointment, participants will be asked to complete a survey about the acceptability of the measurements and tests above.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Biomarker levels (eosinophils, FeNO, CRP, periostin) are measured at baseline, 2, 4 and 6 months

Secondary outcome measures

1. Diagnostic accuracy of near-patient eosinophils compared to laboratory eosinophils is assessed using fingerprick blood test at baseline, 2, 4 and 6 months
2. Feasibility of undertaking such measurements in a primary care setting is assessed using surveys created for the purpose of this study at 6 months

Overall trial start date

01/01/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or Female, aged 40 years or above
3. Have a diagnosis of COPD meeting spirometric criteria for diagnosis of COPD (FEV1/FVC ratio <0.7) as recorded in their primary care records

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Any previous diagnosis of bronchiectasis, cystic fibrosis, interstitial lung disease, lung cancer, alpha-1 anti-trypsin deficiency or other chronic respiratory disease not related to COPD or asthma
2. Co-existent active diagnosis of asthma (reviewed in the last 2 years)
3. Currently prescribed an ICS, or had a prescription for ICS in the last 2 years
4. Regularly takes oral steroids, or has been regularly taking oral steroids in the last 2 years. Regular use of oral steroids will in general be defined as a longer than 2 week course, although discrete short courses with tapering are acceptable for inclusion.
5. Prior inclusion in a clinical trial of an investigational medicinal product for airways disease in the last 90 days or which may involve administration of oral or inhaled steroid treatment

Recruitment start date

01/01/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Oxford Health Centre
Lake Street
Oxford
OX1 4RP
United Kingdom

Trial participating centre

Gosford Hill Medical Centre
167 Oxford Road
Kidlington
OX5 2NS
United Kingdom

Trial participating centre

Berinsfield Health Centre
Fane Drive
Berinsfield
OX10 7NE
United Kingdom

Trial participating centre

Chipping Norton Health Centre
Russell Way
Chipping Norton
OX7 5FA
United Kingdom

Trial participating centre

Donnington Medical Partnership
1 Henley Avenue
Oxford
OX4 4DH
United Kingdom

Trial participating centre

Eynsham Medical Group
Conduit Lane Eynsham
Witney
OX29 4QB
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed primary care and/or respiratory journal, approximately June 2019.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from helen.ashdown@phc.ox.ac.uk

Intention to publish date

30/06/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.