Chronic Obstructive Pulmonary DiseaseNCT03480347
The BLF Early COPD Development Partnership Grant
An observational study of Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2018to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- Adult
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).
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton and Harefield NHS Foundation Trust
London
About this study
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual change in lung function
assessed by post-bronchodilator at 6 monthly intervals over a 3 year period.
Measured: Three years
Annual change in lung function
assessed by body box plethysmography at 6 monthly intervals over a 3 year period.
Measured: Three years
Secondary outcomes (7)
Lung tissue attenuation and airway dimensions
determined by CT-Scanning
Measured: Three years
Lung tissue attenuation and airway dimensions
Assessed by full blood and differential counts
Measured: Three years
Lung tissue attenuation and airway dimensions
Assessed by prevalence of chronic bronchitis as determined by MRC Bronchitis Questionnaire
Measured: Three years
Lung tissue attenuation and airway dimensions
Assessed by respiratory symptoms, as determined by CAT Questionnaire
Measured: Three years
Lung tissue attenuation and airway dimensions
Assessed by dyspnoea as determined by MRC Dyspnoa Scale
Measured: Three years
Lung tissue attenuation and airway dimensions
Assessed by respiratory infections as determined by Respiratory Infection Questionnaire
Measured: Three years
Lung tissue attenuation and airway dimensions
Assessed by depression and anxiety as determined by Hospital Anxiety Depression Scale
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start17 Jan 2018
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480347
- Sponsor's protocol ID
- IRAS Project ID: 206796
- Status last verified
- Aug 2021
- First submitted
- 7 Mar 2018
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ritchie AI, Donaldson GC, Hoffman EA, Allinson JP, Bloom CI, Bolton CE, Choudhury G, Gerard SE, Guo J, Alves-Moreira L, McGarvey L, Sapey E, Stockley RA, Yip KP, Singh D, Wilkinson T, Fageras M, Ostridge K, Jons O, Bucchioni E, Compton CH, Jones P, Mezzi K, Vestbo J, Calverley PMA, Wedzicha JA; British Early COPD Network (BEACON) Cohort Investigators. Structural Predictors of Lung Function Decline in Young Smokers with Normal Spirometry. Am J Respir Crit Care Med. 2024 May 15;209(10):1208-1218. doi: 10.1164/rccm.202307-1203OC.
PubMed 38175920
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BLF Early COPD Development Partnership Grant
- ClinicalTrials.gov ID
- NCT03480347
- Acronym / sponsor ID
- IRAS Project ID: 206796
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- 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
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Age groups
- Adult
- 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).
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Annual change in lung function
Time frame: Three years
assessed by post-bronchodilator at 6 monthly intervals over a 3 year period.
Annual change in lung function
Time frame: Three years
assessed by body box plethysmography at 6 monthly intervals over a 3 year period.
7 secondary outcomes
Lung tissue attenuation and airway dimensions
Time frame: Three years
Lung tissue attenuation and airway dimensions
Time frame: Three years
Lung tissue attenuation and airway dimensions
Time frame: Three years
Lung tissue attenuation and airway dimensions
Time frame: Three years
Lung tissue attenuation and airway dimensions
Time frame: Three years
Lung tissue attenuation and airway dimensions
Time frame: Three years
Lung tissue attenuation and airway dimensions
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 38175920Ritchie AI, Donaldson GC, Hoffman EA, Allinson JP, Bloom CI, Bolton CE, Choudhury G, Gerard SE, Guo J, Alves-Moreira L, McGarvey L, Sapey E, Stockley RA, Yip KP, Singh D, Wilkinson T, Fageras M, Ostridge K, Jons O, Bucchioni E, Compton CH, Jones P, Mezzi K, Vestbo J, Calverley PMA, Wedzicha JA; British Early COPD Network (BEACON) Cohort Investigators. Structural Predictors of Lung Function Decline in Young Smokers with Normal Spirometry. Am J Respir Crit Care Med. 2024 May 15;209(10):1208-1218. doi: 10.1164/rccm.202307-1203OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual change in lung function (time frame: Three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.