Roflumilast Effects on the Chemotactic Capacity of Leukocytes in COPD
Research type
Research Study
Full title
The effects of Roflumilast on the chemotactic capacity of leukocytes from COPD patients
IRAS ID
152077
Contact name
Omar Usmani
Contact email
Eudract number
2014-000895-24
Research summary
This is a study involving 30 patients diagnosed with chronic obstructive pulmonary disease (COPD).
COPD is an inflammatory disorder of the lungs where patients have symptoms of shortness of breath, cough and mucus production. Inhaled steroid drugs (sometimes known as ‘preventers’) dampen down the inflammation caused by white blood cells in the airways of the lungs and they treat the mucus/sputum (an ‘anti-inflammatory’ effect) but they are not always effective in COPD, unlike patients with asthma, and so newer drugs have been developed that are ‘anti-inflammatory’.
The research question is whether Roflumilast (Daxas™), a licensed antinflammatory used in patients with COPD - the test drug in this research study - can affect how quickly white blood cells “travel” from the bloodstream into the lungs.
The study is of relevance and importance to patients and the public as COPD is predicted to be the 3rd commonest cause of death by 2020 and we need to better understand the science of how our current drug treatments work in order to develop more effective treatments for the future, which are greatly needed.
In this study, there will be one drug treatment and placebo given at 5 separate study visits and one screening visit.
Each of the two treatments (drug and placebo) will each be given for 4 weeks and separated by 4 weeks 'washout' (no drug recieved by patients). All patients will receive all treatments (drug and placebo)in a 'crossover' fashion.
Assessments of the lung will be done, which will include clinical history, analysis of the mucus/sputum and blood from COPD patients as well as lung blowing tests.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
14/EE/0154
Date of REC Opinion
11 Jul 2014
REC opinion
Further Information Favourable Opinion