Collection of lung secretionsfrom COPD patients and healthy smokers,v1

• Research type

  Research Study

• Full title

  A Sputum Sample Collection Protocol for Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-Smokers (HMR code: 15-006)

• IRAS ID

  180622

• Contact email

  rec@hmrlondon.com

• Sponsor organisation

  RespiVert Ltd

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Chronic obstructive pulmonary disease (COPD) is a condition where the airways become inflamed (swollen and irritated). Over many years, the inflammation causes permanent changes in the lung. The walls of the airways thicken and more mucus is produced. The air sacs in the lungs are damaged, and the smaller airways become scarred and narrowed. So people with COPD have breathlessness, persistent cough, and produce more phlegm.
  The main cause of COPD is smoking. The likelihood of developing COPD increases the more you smoke and the longer you’ve been smoking, because smoking irritates and inflames the lungs, which results in scarring.

  In this study we’ll collect sputum samples (secretions coughed up from the lungs) from 20 healthy smokers (aged 18–75 years) and 40 COPD patients (20 smokers and 20 ex-smokers, aged 40–75 years). We’ll use the sputum samples to study substances (‘biomarkers’) linked to inflammation and COPD. This is not a study of a medicine.

  Participants will have up to 6 outpatient visits and give 3 sputum samples. There’ll be at least 2 days between visits. Participants will take up to 8 weeks to finish the study.

  A pharmaceutical company (Respivert) is funding the study.

  The study will take place at 1 centre in London. We’ll recruit participants: by advertising; by word of mouth; from volunteer databases; and via our website.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  15/LO/0791

• Date of REC Opinion

  1 Jun 2015

• REC opinion

  Further Information Favourable Opinion