DPM-CF-204 mannitol in CF aged 6-17 years

• Research type

  Research Study

• Full title

  A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years

• IRAS ID

  109521

• Contact name

  Jeremy Hull

• Sponsor organisation

  Pharmaxis Ltd

• Eudract number

  2012-002699-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is a randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years. It is hypothesised that inhaled mannitol 400 mg b.d. will lead to a significant improvement in the absolute change in percentage of predicted FEV1 from baseline following eight-weeks of trial treatment compared to treatment with inhaled placebo b.d

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0434

• Date of REC Opinion

  28 Jan 2013

• REC opinion

  Further Information Favourable Opinion