Effect of Symbicort® on GR in sputum in COPD

• Research type

  Research Study

• Full title

  GR activity in induced sputum macrophages, and a change in inflammatory biomarkers 2-hours after a single dose of either Symbicort®/Budesonide/Formoterol or placebo in Chronic Obstructive Pulmonary Disease (COPD).

• IRAS ID

  28497

• Contact name

  Omar Usmani

• Sponsor organisation

  Imperial College London

• Eudract number

  2010-020440-35

• ISRCTN Number

  Not Sent

• Research summary

  This is a study involving 35 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. The research question is whether inhaled drug treatments in combination (long-acting beta-2-agonists (LABA) together with inhaled corticosteroid (ICS)), that are routinely used for chronic obstructive pulmonary disease (COPD) patients can improve inflammation in the cells of the sputum/mucus from these patients compared to either drug component alone. 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 provide more effective treatments for the future, which are greatly needed. In this therapeutic study, there will be 5 drug treatments given at 5 separate study visits and one screening visit. For some patients, there will be a run-in period of 2 weeks. Treatments will be given as one-off dose-administration from the inhaler and then assessments of the lung will be done, which will include clinical history, analysis of the mucus/sputum from patients and lung blowing tests. There will be no take-home treatments.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  10/H0713/43

• Date of REC Opinion

  18 Aug 2010

• REC opinion

  Further Information Favourable Opinion