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The BLF Early COPD Development Partnership Grant

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ClinicalTrials.gov Identifier: NCT03480347
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
Queen's University, Belfast
University of Southampton
University of Birmingham
University of Leicester
University of Nottingham
University of Edinburgh
University of Manchester
Nanyang Technological University
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease
Chronic Obstructive Pulmonary Disease

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The BLF Early COPD Development Partnership Grant
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : September 3, 2020
Estimated Study Completion Date : September 3, 2020



Primary Outcome Measures :
  1. Annual change in lung function [ Time Frame: Three years ]
    assessed by post-bronchodilator at 6 monthly intervals over a 3 year period.

  2. Annual change in lung function [ Time Frame: Three years ]
    assessed by body box plethysmography at 6 monthly intervals over a 3 year period.


Secondary Outcome Measures :
  1. Lung tissue attenuation and airway dimensions [ Time Frame: Three years ]
    determined by CT-Scanning

  2. Lung tissue attenuation and airway dimensions [ Time Frame: Three years ]
    Assessed by full blood and differential counts

  3. Lung tissue attenuation and airway dimensions [ Time Frame: Three years ]
    Assessed by prevalence of chronic bronchitis as determined by MRC Bronchitis Questionnaire

  4. Lung tissue attenuation and airway dimensions [ Time Frame: Three years ]
    Assessed by respiratory symptoms, as determined by CAT Questionnaire

  5. Lung tissue attenuation and airway dimensions [ Time Frame: Three years ]
    Assessed by dyspnoea as determined by MRC Dyspnoa Scale

  6. Lung tissue attenuation and airway dimensions [ Time Frame: Three years ]
    Assessed by respiratory infections as determined by Respiratory Infection Questionnaire

  7. Lung tissue attenuation and airway dimensions [ Time Frame: Three years ]
    Assessed by depression and anxiety as determined by Hospital Anxiety Depression Scale


Biospecimen Retention:   Samples With DNA
  • Blood samples will be collected to determine full Blood count,. Blood serum, plasma and a blood pellet (DNA) will be stored for further analysis of markers of inflammation and infection.
  • Sputum samples (either spontaneous or induced) will be collected and stored and used for microbiome studies, inflammatory markers, and pathogen detection.


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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes 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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480347


Contacts
Contact: Ethaar El-Emir, PhD +44 (0)20 7594 5668 e.el-emir@imperial.ac.uk
Contact: Gavin Donaldson, PhD 0207 594 7859 gavin.donaldson@imperial.ac.uk

Locations
United Kingdom
Royal Brompton and Harefield NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Ethaar El-Emir         
Sponsors and Collaborators
Imperial College London
Queen's University, Belfast
University of Southampton
University of Birmingham
University of Leicester
University of Nottingham
University of Edinburgh
University of Manchester
Nanyang Technological University

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03480347     History of Changes
Other Study ID Numbers: IRAS Project ID: 206796
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases