Study to investigate the effects of AZD8871 in patients with COPD

• Research type

  Research Study

• Full title

  A phase IIa, randomised, multi-centre, double-blind, placebo-controlled, 3 periods, crossover study to investigate the efficacy, pharmacokinetics, safety and tolerability of inhaled AZD8871 administered once daily for 2 weeks in patients with moderate to severe COPD

• IRAS ID

  213296

• Contact name

  Minal Kara

• Contact email

  01895614869

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2016-002863-32

• Duration of Study in the UK

  0 years, 9 months, 1 days

• Research summary

  Chronic obstructive pulmonary disease (COPD) is a lung disease in the airways that carry air in and out of your lungs, making it difficult to breathe. COPD is a persistent condition that gets gradually worse over time. COPD is usually caused by smoking and the best way to slow the disease is to stop smoking. In order to help patients breathe, COPD patients are treated with one or more medications that expand the airways, these are known as bronchodilators. AZD8871 is a new type of bronchodilator currently in development.\nThe purpose of this study is to see how effective different doses of the study medication AZD8871 are in improving lung function in patients with stable, moderate to very severe COPD. \nFor each participant the study includes 3 periods where a different study treatment is received for 14 days, (i.e. 2 different doses of AZD8871 and placebo). These 3 treatment periods are separated by a wash-out period where an existing bronchodilator for COPD is provided.\nIt is a randomized study, meaning that for each patient the order of the treatments is randomly assigned; it is placebo-controlled meaning one of the treatments will be a placebo (dummy) medication which looks the same as the AZD8871 treatments, it is a crossover study meaning that all of the patients will receive all of the 3 treatments and it is double−blind meaning neither the patient nor the study doctor will know which medication is being given during each period.\nAstraZeneca is the sponsor of this study which will take place across 2 sites in Germany and UK. It is anticipated that approximately 42 participants will be recruited. \n

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  16/NW/0664

• Date of REC Opinion

  4 Nov 2016

• REC opinion

  Further Information Favourable Opinion