Phase II Efficacy Study of Oral AZD5069 in Bronchiectasis Patients

• Research type

  Research Study

• Full title

  A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28-Day Oral Administration of AZD5069 Twice Daily in Patients with Bronchiectasis

• IRAS ID

  57981

• Contact name

  Robert A Stockley

• Sponsor organisation

  AstraZeneca

• Eudract number

  2010-021472-28

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  AZD5069 is an investigational new drug that is being developed for the treatment of patients with chronic obstructive pulmonary disease (COPD). COPD is a lung disease in which patients cough up lots of phlegm, their lung airways become narrowed and gradually, their normal lung tissue is destroyed. In most developed countries, COPD is mainly caused by smoking. Studies suggest that smoking activates (amongst others) a particular type of white blood cell called the neutrophil. Once activated, for example, in response to inhaled smoke, this cell travels to the lung and is thought to take part in the process of lung destruction. Once lung destruction has begun, these cells may continue to attack the lung tissue in some patients even if they no longer continue to smoke.The neutrophil is activated by certain proteins binding to the CXCR2 chemokine receptor on its surface. AZD5069 is a drug that blocks the receptor, and is thought to stop neutrophils moving to the lung in vast numbers and taking part in the process of lung destruction. Bronchiectasis, in some respects, is considered as an exaggerated model of COPD as neutrophil numbers in the sputum are consistently higher in this condition than in stable COPD. There is a considerable overlap between bronchiectasis and COPD, with many People'suffering from both. Patients with bronchiectasis will take part in this research study. The main purpose of this study is to establish the proof-of-principle that the CXCR2 receptor antagonist AZD5069 shows some effect on the number of neutrophils in the sputum of bronchiectasis patients, so that one could proceed with confidence to longer-term proof-of-concept studies in COPD patients. The study is also intended to obtain further clinical effects, safety and tolerability data prior to proof-of-concept and dose finding studies in COPD patients.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  10/H0308/91

• Date of REC Opinion

  10 Jan 2011

• REC opinion

  Further Information Favourable Opinion