Study of AZD1981 in Patients with Moderate to Severe COPD

• Research type

  Research Study

• Full title

  A Double-Blind, Placebo-Controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2008-000311-15

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  AstraZeneca are developing a new respiratory drug. This study is a randomised, placebo??controlled, double blind study which aims to see if a new respiratory drug is effective and safe in treating respiratory disease. Approximately 40 patients, men and post menopausal women, aged 40 years or over will take part at around 10 sites in 4 European countries. Patients will be randomly assigned so that half of the patients will be receive the new respiratory drug and the other half will receive a placebo (inactive drug); although neither the patients or doctors will know which treatment has been given. Patients will have to attend 9 clinic visits throughout the study over a period of 8??9 weeks. During the visits they will have a variety of tests including: 1.Blood and urine tests ?? for routine monitoring of the patient and for safety monitoring of the study drug 2.Bronchoscopy and sputum samples ?? procedures to collect lung samples to assess chemicals involved in respiratory disease 3.Spirometry ?? a technique for measuring lung function 4. Assessment of breathlessness upon activity 5.Questionnaires ?? to assess the extent of the patient??s respiratory disease Patients will also be asked to keep a diary to record their medication, disease symptoms and lung function. Patients will have the opportunity to donate separate blood samples to test for genetic factors (DNA test) of respiratory disease. Patients can still be involved in the main study if they do not wish to take part in this genetic arm of the study

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  08/H1010/57

• Date of REC Opinion

  14 Nov 2008

• REC opinion

  Further Information Favourable Opinion