Inhaled Promixin in the treatment of non-CF Bronchiectasis

• Research type

  Research Study

• Full title

  A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin

• IRAS ID

  4784

• Sponsor organisation

  Profile Pharma Ltd

• Eudract number

  2008-005045-34

• ISRCTN Number

  ISRCTN49790596

• Clinicaltrials.gov Identifier

  NCT

• Research summary

  Bronchiectasis not associated with cystic fibrosis (Non-CF bronchiectasis) is a chronic lung disease that produces blocked airways. The main problem is persistent or recurrent cough with production of thick and unpleasant sputum. Many patients also feel very unwell and have fever, loss of appetite and weight loss. The disease has periods where symptoms become much worse (called exacerbations) often caused by an infection. A common bacterial infection causing exacerbations is from something called Pseudomonas aeruginosa. Some doctors give patients inhaled antibiotics every day in an attempt to stop these exacerbations or make them less frequent. However, this treatment is not yet approved. This study is to look at the effect of an inhaled antibiotic (called Promixin) on the length of time to an exacerbation compared to the standard treatment of just treating the exacerbation when it occurs.

• REC name

  London - Central Research Ethics Committee

• REC reference

  08/H0718/71

• Date of REC Opinion

  15 Dec 2008

• REC opinion

  Further Information Favourable Opinion