RDB, 4-way cross-over study in healthy and mild asthmatic adults

• Research type

  Research Study

• Full title

  Serial lung function measurements in 12 healthy and 48 mild asthmatic adults after oral inhalation of ethanolic solutions containing two concentrations of the excipient butylated hydroxytoluene (BHT, 0.1 and 0.5%) administered with the Respimat® B (RMT-B) vs. corresponding RMT-B and HFA MDI without BHT; repeated increasing doses with 2,4, and 6 actuations of low concentration prior to high concentration on separate days, double blind for RMT-B use, randomised 4-way crossover design

• IRAS ID

  33374

• Contact name

  Maura Fallon

• Sponsor organisation

  Boehringer Ingelheim Pharma GmbH & Co. KG

• Eudract number

  2009-013278-42

• ISRCTN Number

  finished

• Research summary

  The aim of the study is to investigate an antioxidant called Butylated Hydroxytoluene, referred to as ??BHT? which is widely used as a preservative/stabiliser of foods. The main purpose of the study is to see how safe BHT solution is and how well it is tolerated after inhalation in patients with mild asthma. The study will also investigate how much BHT is absorbed into the blood and the effect of BHT on lung function.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  09/H0301/72

• Date of REC Opinion

  23 Nov 2009

• REC opinion

  Further Information Favourable Opinion