Efficacy of Medi-563 in COPD patients with sputum eosinophilia

• Research type

  Research Study

• Full title

  A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects with Moderate-to-Severe COPD and Sputum Eosinophilia

• IRAS ID

  58536

• Contact name

  Christopher Brightling

• Eudract number

  2010-020127-52

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Exacerbation is known as a continued worsening of COPD symptoms compared with how one normally feels and is worse than any usual day-to-day variation of COPD symptoms. It can include a worsening of breathlessness, cough, increased sputum (thick saliva) production and a change in the color of your sputum. Eosinophils (a type of white blood cell), play a role in the symptoms that patients experience as part of this disease. MEDI-563 has been shown to decrease eosinophils in the blood and may help control the symptoms you experience as part of COPD. The purpose of this study is to see if MEDI-563, given as an injection under the skin, can help reduce the number of exacerbations. The procedures performed will include blood test, temperature measurement, blood pressure, pulse rate and breathing rate checked. In addition, the study is being done to see how much MEDI-563 remains in the blood after taking it. There will be about 90 people in this study, carried out at about 30 sites in Canada and Europe over a 3 year period. The planned length of time for the study including follow-up is 88 weeks; up to 4 weeks for screening, 4 weeks for run-in; 48 weeks of treatment during which time 8 doses of study medication will be given and then a further 32 weeks of follow-up. In order to participate the subject must be an study adult aged between 40 to 85 years old with moderate-to-severe COPD and have had an exacerbation diagnosed by your doctor in the last 2 to 12 months. The sputum eosinophil count must be = 3.0% within 12 months prior to, or at the screening visit. All visits to will occur at the doctor??s clinic and an electronic device to report on how the subject feels on a daily basis will be provided.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/61

• Date of REC Opinion

  8 Sep 2010

• REC opinion

  Further Information Favourable Opinion