A study of Oral BAY 85-8501 in Patients with non-CF Bronchiectasis

• Research type

  Research Study

• Full title

  A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis

• IRAS ID

  120589

• Contact name

  Simon Bourne

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2012-004491-18

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  BAY 85-8501 is a drug that is being investigated as a treatment for patients with non-Cystic Fibrosis Bronchiectasis. It is given by tablet that is taken with water, after eating. It works by inhibiting an enzyme (called neutrophil elastase) that plays an important role in the development of chronic inflammation in the airways of people with Bronchiectasis. It is expected that by inhibiting this enzyme BAY 85-8501 will reduce inflammation and destruction of the lungs. The purpose of this study is to find out if the oral investigational drug BAY 85-8501 is safe and effective in the treatment of non-cystic fibrosis bronchiectasis. During the treatment phase, participants will receive the study drug, as two 0.5mg tablets, once every day for 28 days. Following this, participants will enter a follow-up phase for 28 days. During the study, participants will have blood and urine tests and general checks on their health and quality of life. The study treatment will be given on top of the standard treatment for Bronchiectasis. It is estimated that 90 patients will be recruited worldwide onto the study. Half of the patients participating in the trial will receive study drug, while the other half will receive a placebo (dummy drug) to act as a comparator. The study is being sponsored by Bayer HealthCare AG. The study will be run in a number of countries worldwide, and at approximately 10 hospitals in the UK.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  13/SC/0010

• Date of REC Opinion

  28 Jan 2013

• REC opinion

  Favourable Opinion