The BLF Early COPD Development Partnership Grant

NCT ID: NCT03480347

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-17
• Study Completion Date: 2023-04-30

Brief Summary

Most existing medical research has focused on patients with well-established COPD and poor lung function. Whilst this is important because such patients have lots of symptoms and problems, in some respects a better way of reducing health problems in the future would be to develop a strategy which focuses on patients with milder disease, and identifies which ones will go on to develop more severe problems and why these problems occur. The research in this application is designed to investigate these issues.

The main objective of the Partnership is to study the very early stages of the development of COPD. The investigators will do this by recruiting a novel cohort of smokers (age 30-45), in whom the investigators will follow the trajectories of lung function decline to identify prospectively those at risk of excess decline. This programme forms a unique UK consortium of 8 academic centres with excellent high quality publication records and broad experience in mechanistic, translational, clinical and epidemiological studies in COPD with key capabilities including primary care.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Subjects eligible for enrolment in the study must meet all the following criteria:

• Informed Consent: Subjects must give their signed and dated written informed consent to participate
• Gender: Male or female subjects
• Age: 30-45 years of age at screening
• Smokers of at least 10 pack years
• Have either normal lung function or mild lung function abnormalities
• Subject groups will have one of the following:

• A. Subjects (smokers) with mild airflow limitation defined as an FEV1/FVC ratio <lower limit of normal and FEV1 > 80% of predicted normal and no symptoms. This group will make up at least 30% of the total cohort.
• B. Subjects (smokers) with mild airflow limitation as defined above and presence of respiratory symptoms defined as presence of chronic cough and/or chronic sputum and/or breathlessness equivalent to mMRC Grade 1 or higher. This group will make up no more than 25% of the total cohort.
• C. Subjects (smokers) with normal lung function defined as FEV1/FVC > lower limit of normal and FEV1 > 80% of predicted normal, with or without symptoms. This group will make up at least 30% of the total cohort.

Exclusion Criteria

• Individuals currently diagnosed and treated for asthma will be excluded from the study, but individuals with a past history of childhood wheezing and of asthma may be included provided that they did not previously receive regular maintenance inhaled therapy with inhaled corticosteroids'
• Subjects with another known chronic respiratory disease - other than mild airflow limitation as defined above, predominantly cannabis or shisha smokers
• Subjects with autoimmune disease, diabetes, hypertension, thyroid disease or bronchiectasis, significant cardio-renal disease (including significant hypertension, atrial fibrillation, Hypertrophic Cardiomyopathy, significant cardiovascular disease), Malignancies.
• Clinically relevant abnormal laboratory values available at the screening assessment that could interfere with the objectives of the study or safety of the volunteer.
• Subjects who are actively enrolled in an interventional clinical trial
• Subjects with BMI >35
• Female participants who are pregnant or breastfeeding.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

Nanyang Technological University

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Brompton and Harefield NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

References

Ritchie AI, Donaldson GC, Hoffman EA, Allinson JP, Bloom CI, Bolton CE, Choudhury G, Gerard SE, Guo J, Alves-Moreira L, McGarvey L, Sapey E, Stockley RA, Yip KP, Singh D, Wilkinson T, Fageras M, Ostridge K, Jons O, Bucchioni E, Compton CH, Jones P, Mezzi K, Vestbo J, Calverley PMA, Wedzicha JA; British Early COPD Network (BEACON) Cohort Investigators. Structural Predictors of Lung Function Decline in Young Smokers with Normal Spirometry. Am J Respir Crit Care Med. 2024 May 15;209(10):1208-1218. doi: 10.1164/rccm.202307-1203OC.

Reference Type: DERIVED

PMID: 38175920 (View on PubMed)

Other Identifiers

IRAS Project ID: 206796

Identifier Type: -

Identifier Source: org_study_id