The BLF Early COPD Development Partnership Grant

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The BLF Early COPD Development Partnership Grant

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03480347
• Other study ID #: IRAS Project ID: 206796
• Status: Active, not recruiting
• Start date: January 17, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Foundation Trust	London

Sponsors (9)

Lead Sponsor	Collaborator
Imperial College London	Nanyang Technological University, Queen's University, Belfast, University College, London, University of Birmingham, University of Edinburgh, University of Manchester, University of Nottingham, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual change in lung function	assessed by post-bronchodilator at 6 monthly intervals over a 3 year period.	Three years
Primary	Annual change in lung function	assessed by body box plethysmography at 6 monthly intervals over a 3 year period.	Three years
Secondary	Lung tissue attenuation and airway dimensions	determined by CT-Scanning	Three years
Secondary	Lung tissue attenuation and airway dimensions	Assessed by full blood and differential counts	Three years
Secondary	Lung tissue attenuation and airway dimensions	Assessed by prevalence of chronic bronchitis as determined by MRC Bronchitis Questionnaire	Three years
Secondary	Lung tissue attenuation and airway dimensions	Assessed by respiratory symptoms, as determined by CAT Questionnaire	Three years
Secondary	Lung tissue attenuation and airway dimensions	Assessed by dyspnoea as determined by MRC Dyspnoa Scale	Three years
Secondary	Lung tissue attenuation and airway dimensions	Assessed by respiratory infections as determined by Respiratory Infection Questionnaire	Three years
Secondary	Lung tissue attenuation and airway dimensions	Assessed by depression and anxiety as determined by Hospital Anxiety Depression Scale	Three years