Observational study in healthy subjects and patients with Chronic obstructive pulmonary disease (COPD) to assess the relationship between clinical, imaging and biomarker measurements, and progression of emphysema over three years
Research type
Research Study
Full title
Observational study in healthy subjects and patients with Chronic obstructive pulmonary disease (COPD) to assess the relationship between clinical, imaging and biomarker measurements, and progression of emphysema over three years.
IRAS ID
190627
Contact name
Dave Singh
Contact email
Sponsor organisation
Boehringer Ingelheim
Duration of Study in the UK
2 years, 9 months, 10 days
Research summary
Summary of Research
This study will assess the relationship between clinical, imaging and biomarker measurements, and progression of emphysema over two years (104 weeks). This study will be conducted on healthy subjects and patients with COPD, to identify bio-markers (soluble, functional imaging and physiological) that may be useful in differentiating a patient population with ongoing emphysematous destruction of lung parenchyma, which may enable development of drugs aiming at the reduction of COPD. There will be no direct benefit for the participating subjects except the benefit which derives from the periodic monitoring of their health or disease status by the investigator and site staff. All subjects are allowed to continue their usual care. This study will include 125 healthy subjects (ex-smokers without airflow limitation), 125 COPD GOLD 1, 125 COPD GOLD 2, 125 COPD GOLD 3, and up to 40 (with a minimum of 20) patients with COPD and A1AT deficiency (ZZ genotype). Soluble and imaging biomarkers will be investigated addressing different aspects of disease pathways postulated to be relevant for COPD progression.
Clinical assessments will consist of Spirometry, Body plethysmography, Pulse oximetry, DL,CO, Symptom questionnaires: mMRC, CAT, SGRQ, BODE index, 6 MWT
Biofluid collection will consist of Sputum, Blood, Urine
Imaging assessments will consist of chest computed tomography (CT), Magnet Resonance Imaging (MRI in a subset population)
Summary of Results
As this was a biomarker only study, no Lay Summary will be produced
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
16/NW/0104
Date of REC Opinion
8 Apr 2016
REC opinion
Further Information Favourable Opinion