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Status unknownNCT03480347Updated Aug 26, 2021

The BLF Early COPD Development Partnership Grant

An observational study in Chronic Obstructive Pulmonary Disease, sponsored by Imperial College London. Status unknown at 1 site in United Kingdom. Open to participants aged 30 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-08-26.

Sponsored by Imperial College London · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
30 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
03

Who can participate

Ages eligible
30 Years to 45 Years
Sexes eligible
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).

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Annual change in lung function

    assessed by post-bronchodilator at 6 monthly intervals over a 3 year period.

    Time frame: Three years

  2. Annual change in lung function

    assessed by body box plethysmography at 6 monthly intervals over a 3 year period.

    Time frame: Three years

Secondary outcomes

  1. Lung tissue attenuation and airway dimensions

    determined by CT-Scanning

    Time frame: Three years

  2. Lung tissue attenuation and airway dimensions

    Assessed by full blood and differential counts

    Time frame: Three years

  3. Lung tissue attenuation and airway dimensions

    Assessed by prevalence of chronic bronchitis as determined by MRC Bronchitis Questionnaire

    Time frame: Three years

  4. Lung tissue attenuation and airway dimensions

    Assessed by respiratory symptoms, as determined by CAT Questionnaire

    Time frame: Three years

  5. Lung tissue attenuation and airway dimensions

    Assessed by dyspnoea as determined by MRC Dyspnoa Scale

    Time frame: Three years

  6. Lung tissue attenuation and airway dimensions

    Assessed by respiratory infections as determined by Respiratory Infection Questionnaire

    Time frame: Three years

  7. Lung tissue attenuation and airway dimensions

    Assessed by depression and anxiety as determined by Hospital Anxiety Depression Scale

    Time frame: Three years

06

Study locations

1 site
  • Royal Brompton and Harefield NHS Foundation Trust
    London, United Kingdom
07

Registry details

Key details

Study ID
NCT03480347
Lead sponsor
Imperial College London
Collaborators
Queen's University, Belfast, University of Southampton, University of Birmingham, University College, London, University of Nottingham, University of Edinburgh, University of Manchester, Nanyang Technological University
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Jan 17, 2018
Primary completion
Apr 30, 2023 (estimated)
Completion
Apr 30, 2023 (estimated)
Last update
Aug 26, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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