The BLF Early COPD Development Partnership Grant

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Royal Brompton and Harefield NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

You can take part in the study if you are 30-45 years of age and you are a current smoker (smokers of at least 10 pack years).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual change in lung function	assessed by post-bronchodilator at 6 monthly intervals over a 3 year period.	Three years
Annual change in lung function	assessed by body box plethysmography at 6 monthly intervals over a 3 year period.	Three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung tissue attenuation and airway dimensions	determined by CT-Scanning	Three years
Lung tissue attenuation and airway dimensions	Assessed by full blood and differential counts	Three years
Lung tissue attenuation and airway dimensions	Assessed by prevalence of chronic bronchitis as determined by MRC Bronchitis Questionnaire	Three years
Lung tissue attenuation and airway dimensions	Assessed by respiratory symptoms, as determined by CAT Questionnaire	Three years
Lung tissue attenuation and airway dimensions	Assessed by dyspnoea as determined by MRC Dyspnoa Scale	Three years
Lung tissue attenuation and airway dimensions	Assessed by respiratory infections as determined by Respiratory Infection Questionnaire	Three years
Lung tissue attenuation and airway dimensions	Assessed by depression and anxiety as determined by Hospital Anxiety Depression Scale	Three years

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: University of Nottingham; University College, London; University of Southampton; Queen's University, Belfast; University of Edinburgh; University of Manchester; University of Birmingham; Nanyang Technological University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2018
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

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: IRAS Project ID: 206796

Drug and device information, study documents

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