The BLF Early COPD Development Partnership Grant
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
-
London, Storbritannia
- Royal Brompton and Harefield NHS Foundation Trust
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Annual change in lung function
Tidsramme: Three years
|
assessed by post-bronchodilator at 6 monthly intervals over a 3 year period.
|
Three years
|
|
Annual change in lung function
Tidsramme: Three years
|
assessed by body box plethysmography at 6 monthly intervals over a 3 year period.
|
Three years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lung tissue attenuation and airway dimensions
Tidsramme: Three years
|
determined by CT-Scanning
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Tidsramme: Three years
|
Assessed by full blood and differential counts
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Tidsramme: Three years
|
Assessed by prevalence of chronic bronchitis as determined by MRC Bronchitis Questionnaire
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Tidsramme: Three years
|
Assessed by respiratory symptoms, as determined by CAT Questionnaire
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Tidsramme: Three years
|
Assessed by dyspnoea as determined by MRC Dyspnoa Scale
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Tidsramme: Three years
|
Assessed by respiratory infections as determined by Respiratory Infection Questionnaire
|
Three years
|
|
Lung tissue attenuation and airway dimensions
Tidsramme: Three years
|
Assessed by depression and anxiety as determined by Hospital Anxiety Depression Scale
|
Three years
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRAS Project ID: 206796
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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