Sensitivity of OE-MRI to detect treatment responses in COPD patients

• Research type

  Research Study

• Full title

  An open, randomised, parallel group multi-centre, methodology study, evaluating the Sensitivity of Oxygen-Enhanced Magnetic Resonance Imaging (OE-MRI) in detecting and comparing response to 8 weeks treatment with budesonide/formoterol Turbuhaler® (320/9 µg b.i.d.) and formoterol Turbuhaler® (9 µg b.i.d.) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

• IRAS ID

  67986

• Contact name

  D Singh

• Sponsor organisation

  AstraZeneca

• Eudract number

  2010-023751-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT01257048

• Research summary

  The overall aim of this study is to develop quantitative assessment techniques that are sensitive enough to allow for small improvements in lung function (such as those generated by less than a few months of pharmacological treatment of COPD) to be detected and quantified. It is hypothesized that the OE-MRI technique is more sensitive in that it allows changes in regional lung function to be assessed. The standard lung function tests such as spirometry, body plethysmography and diffusing capacity for carbon monoxide all provide global indices only. OE-MRI also provides regional information, which should be of vital importance in the study of highly heterogeneous lung diseases such as COPD.This will be an open, active-controlled, parallel-group, randomised study, with an initial inhaled corticosteriod (ICS) washout period of 14-19 days and a treatment period of 56() days.Symptomatic patients with moderate to severe COPD at a stable state will be included in the study at two centres, one in UK and one in Sweden. A sufficient number of patients will be enrolled at two centres (one in UK and one in Sweden) in order to reach 36 evaluable patients (24 on budesonide/formoterol and 12 on formoterol).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0247

• Date of REC Opinion

  29 Jun 2011

• REC opinion

  Further Information Favourable Opinion