RCT of azithromycin maintenance therapy in Primary Ciliary Dyskinesia

• Research type

  Research Study

• Full title

  RANDOMIZED CONTROLLED TRIAL (RCT) TO DETERMINE THE EFFICACY AND SAFETY OF AZITHROMYCIN (AZN) MAINTENANCE THERAPY FOR 6 MONTHS IN SUBJECTS WITH PCD - A DOUBLE-BLIND, PARALLEL GROUP STUDY

• IRAS ID

  150015

• Contact name

  Claire Hogg

• Contact email

  c.hogg@rbht.nhs.uk

• Sponsor organisation

  Paediatric Pulmonary Service, Copenhagen University Hospital, Rigshospitalet

• Eudract number

  2013-004664-58

• Research summary

  The purpose of the study is to determine the efficacy of 6 months of maintenance treatment with AZN on respiratory system exacerbations in subjects with Primary Ciliary Dyskinesia (PCD), 7-40 years of age.
  Maintenance therapy with AZN is hypothesized to provide significant improvements in PCD lung disease, compared to placebo: reduction in respiratory system exacerbations and improvement in lung function, ventilation inhomogeneity, improvement in respiratory symptoms and hearing impairment.

• REC name

  London - Central Research Ethics Committee

• REC reference

  14/LO/1279

• Date of REC Opinion

  30 Oct 2014

• REC opinion

  Further Information Favourable Opinion