- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02740686
Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD (CIMPRES-COPD)
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Lincoln, Yhdistynyt kuningaskunta, LN2 2EF
- Sudbrooke Drive Community Centre
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Lincoln, Yhdistynyt kuningaskunta, LN5 8QS
- Bracebridge Community Centre
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Lincolnshire
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Lincoln, Lincolnshire, Yhdistynyt kuningaskunta, LN2 2JP
- Lindum Medical Practice
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Lincoln, Lincolnshire, Yhdistynyt kuningaskunta, LN2 2RS
- Nettleham Medical Practice
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Lincoln, Lincolnshire, Yhdistynyt kuningaskunta, LN6 0QQ
- Birchwood Medical Practice
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Lincoln, Lincolnshire, Yhdistynyt kuningaskunta, LN2 3JH
- Welton Surgery
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
116 COPD patients, confirmed by diagnosis, will be recruited (58 frequent and 58 infrequent exacerbators in accordance with criteria listed above) to the study who have been referred to, and are about to enrol, on pulmonary rehabilitation.
20 healthy smokers and 20 healthy never smokers will be recruited for baseline measurements to compare with COPD patients.
Kuvaus
Inclusion Criteria:
- 58 frequent exacerbators and 58 infrequent exacerbators (116 in total) who have been diagnosed with any severity of COPD (according to BTS criteria, i.e. >10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio <0.70 and FEV<80%).
Exclusion Criteria:
- Inability or unwillingness to sign informed consent
- Any unstable ongoing cardiovascular events which may be exacerbated by exercise
- Inability to complete walk tests due to physical or mental impairment
- Other active inflammatory conditions e.g. rheumatoid arthritis, cancer.
- Known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis)
Healthy control group - Patients who have not been diagnosed with COPD or any other respiratory condition and are characteristically (age (between 45-85 years old) & smoking status) matched to recruited COPD patients.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
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Frequent exacerbators
Exacerbations will be defined as "a respiratory event which led to a hospitalisation or the prescription of antibiotics and/or oral corticosteroids".
Clinicians will ask patients to retrospectively recall how many exacerbations they have had in the past 12 months.
Patients will be allocated to the frequent exacerbators group based on whether they have had 2 or more hospitalisations for exacerbations or have taken 2 or more courses on steroids/antibiotics within the past 12 months.
Blood sample collection at the following pulmonary rehabilitation sessions: 1st (pre-exercise), 2nd (pre and post-exercise), 8th (pre-exercise), last session (pre and post exercise).
Sputum samples collected pre-exercise at the following pulmonary rehabilitation sessions: 1st, 8th, and last session.
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Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation.
No other intervention will be administered.
Healthy controls will have resting blood samples taken.
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Infrequent exacerbators
Exacerbations will be defined as "a respiratory event which led to a hospitalisation or the prescription of antibiotics and/or oral corticosteroids".
Clinicians will ask patients to retrospectively recall how many exacerbations they have had in the past 12 months.
Patients will be allocated to the infrequent exacerbators group based on whether they have had no more than 1 hospitalisation for exacerbations or have not taken more than 1 course of steroids/antibiotics within the past 12 months.
Blood sample collection at the following pulmonary rehabilitation sessions: 1st (pre-exercise), 2nd (pre and post-exercise), 8th (pre-exercise), last session (pre and post exercise).
Sputum samples collected pre-exercise at the following pulmonary rehabilitation sessions: 1st, 8th, and last session.
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Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation.
No other intervention will be administered.
Healthy controls will have resting blood samples taken.
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Healthy smokers
Recruited in accordance with inclusion/exclusion criteria with no medical history of COPD diagnosis and currently smoke.This group will be recruited by a nurse using medical records to assess smoking status and age-matching to the COPD groups.
A resting blood sample will be taken from these patients and used to compare baseline measurements with the COPD groups.
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Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation.
No other intervention will be administered.
Healthy controls will have resting blood samples taken.
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Healthy never smokers
Recruited in accordance with inclusion/exclusion criteria with no medical history of COPD diagnosis and have never smoked.This group will be recruited by a nurse using medical records to assess smoking status and age-matching to the COPD groups.
Resting blood samples will be taken from these patients and used to compare baseline measurements with the COPD groups.
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Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation.
No other intervention will be administered.
Healthy controls will have resting blood samples taken.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Concentration of inflammatory markers in plasma and sputum (C-reactive protein, Fibrinogen, Interleukin(IL)-6, IL-8
Aikaikkuna: July 2016 - August 2018
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July 2016 - August 2018
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Changes in the expression of anti-inflammatory genes
Aikaikkuna: July 2016 - August 2018
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July 2016 - August 2018
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Total and differential blood leukocyte count
Aikaikkuna: July 2016 - August 2018
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July 2016 - August 2018
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Pre-activation and activation of blood neutrophils using flow cytometry
Aikaikkuna: July 2016 - August 2018
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July 2016 - August 2018
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Pro-coagulant and pro-inflammatory microparticle signatures in plasma
Aikaikkuna: July 2016 - August 2018
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July 2016 - August 2018
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Severe, moderate and mild exacerbations (number of /days to defined events, severity, recovery)
Aikaikkuna: July 2016 - August 2018
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July 2016 - August 2018
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Respiratory Symptoms™ (RS-Total score; RS-Breathlessness; RS-Cough and Sputum, and RS-Chest Symptoms)
Aikaikkuna: July 2016 - August 2018
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July 2016 - August 2018
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Routine clinical outcome measures following pulmonary rehabilitation (completion rates and clinically important differences - ISWT, ESWT, 6MWD, CRQ)
Aikaikkuna: July 2016 - August 2018
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July 2016 - August 2018
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Differences in basal levels of inflammation between frequent and infrequent exacerbators in comparison to healthy controls
Aikaikkuna: July 2016 - August 2018
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July 2016 - August 2018
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Alex R Jenkins, MPhil, PhD student
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 16/LO/0865
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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Kliiniset tutkimukset Sample collection
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Hillel Yaffe Medical CenterTuntematon