Clinical trial NCT03480347: The BLF Early COPD Development Partnership Grant
Official title: The BLF Early COPD Development Partnership Grant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Queen's University, Belfast
name: University of Southampton
name: University of Birmingham
name: University College, London
name: University of Nottingham
name: University of Edinburgh
name: University of Manchester
name: Nanyang Technological University
First posted: 2018-03-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


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.

Primary outcomes:
measure: Annual change in lung function
timeFrame: Three years
measure: Annual change in lung function
timeFrame: Three years
Secondary outcomes:
measure: Lung tissue attenuation and airway dimensions
timeFrame: Three years
measure: Lung tissue attenuation and airway dimensions
timeFrame: Three years
measure: Lung tissue attenuation and airway dimensions
timeFrame: Three years
measure: Lung tissue attenuation and airway dimensions
timeFrame: Three years
measure: Lung tissue attenuation and airway dimensions
timeFrame: Three years
measure: Lung tissue attenuation and airway dimensions
timeFrame: Three years
measure: Lung tissue attenuation and airway dimensions
timeFrame: Three years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
Study officials:
References: