Efficacy of 28 days of AZD9668 in Patients with bronchiectasis

• 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 AZD9668 in Patients with Bronchiectasis

• Contact name

  Robert Stockley

• Sponsor organisation

  AstraZeneca

• Eudract number

  2008-000753-35

• ISRCTN Number

  N/A

• Research summary

  AZD9668 is a new investigational medication being developed for the treatment of bronchiectasis. Bronchiectasis is a permanent abnormal widening (dilation) in the lung's airways (bronchi) in which the airways are damaged and inflamed. The inflamed airways tend to produce more mucus, which collects in the lung and makes it more prone to further infection. This inflammation in the airways of participants with bronchiectasis is characterised by the presence of inflammatory cells called neutrophils. When neutrophils break down they release into the airways a destructive enzyme called elastase which digests the lung tissue, thus setting up a vicious cycle of infection, inflammation, lung damage and further infection and inflammation. AZD9668 inhibits the actions of neutrophil elastase. The study will see if AZD9668 is able to prevent the damaging effects of neutrophil elastase and improve some of the signs and symptoms of bronchiectasis, and if so, how it compares with a placebo (a dummy tablet which does not have any action). Patients known to have Bronchiectasis diagnosed by a CT scan of the lungs and who have provided written informed consent , will be enrolled into the study. Participants will receive AZD 9668 as a tablet twice daily or a matching placebo and be required to attend 10 clinic visits (some of which may be undertaken in their own home) over a maximum period of approximately 10 weeks. During the visits they will have a blood sample taken and the sputum they cough up will be collected to analyse the presence of any Elastase.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  08/H0706/89

• Date of REC Opinion

  29 Oct 2008

• REC opinion

  Further Information Favourable Opinion