Status:
UNKNOWN
The BLF Early COPD Development Partnership Grant
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Queen's University, Belfast
University of Southampton
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
30-45 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 res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03480347
Start Date
January 17 2018
End Date
April 30 2023
Last Update
August 26 2021
Active Locations (1)
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1
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom