Phase 0 to investigate Bacterial Load on Fibrosis Bronchiectasis

• Research type

  Research Study

• Full title

  Prospective Phase 0 Study to Investigate Pseudomonas aeruginosa and Staphylococcus aureus Bacterial Load, Patient Characteristics and Exploratory Biomarkers in Adult Patients with Cystic Fibrosis or Non-Cystic Fibrosis Bronchiectasis

• IRAS ID

  280258

• Contact name

  Nick Hodges

• Contact email

  GCOUKSubmissions@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Clinicaltrials.gov Identifier

  CPMS number, 44996

• Duration of Study in the UK

  0 years, 10 months, 28 days

• Research summary

  Cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (NCFB) are diseases of high unmet medical need characterized by an impaired self-clearing mechanism of the airways in the respiratory system and decline of lung function associated with high morbidity and mortality due to infectious exacerbations. Important risk factors for such exacerbations include Pseudomonas aeruginosa (PA) and/or Staphylococcus aureus (SA) bacterial infection.
  In both CF and NCFB patients, current standard-of-care antibiotics have proven inadequate in addressing long-term outcomes of the disease. The Sponsor is developing a novel engineered bacteriophage approach to addressing this unmet need. Bacteriophages represent an alternative or complementary treatment modality to standard-of-care antibiotics. The intent is to develop a cocktail of bacteriophage that are able to target sequences in the bacterial chromosome to irreversibly damage it beyond repair.
  This is a phase 0 study and does not involve the administration of any medication. It will:
  Evaluate variability in sputum bacterial load over time in participants with CF or NCFB
  Evaluate the impact of standard-of-care antibiotics and other treatments for CF on bacteria levels in participants with CF
  Explore bacterial environment in respiratory tract variability in participants with CF or NCFB
  Explore if participant phlegm and/or blood have specific biomarkers (substances that can be used to monitor the progress of a condition or assess a response to therapy).

  The participant will be in the study for 2 months and during this time will provide 4 sputum samples and 4 blood samples. There are 4 study visits
  o Visit 1 is the screening visit
  o Visit 2 is the enrollment or study entry visit
  o Visit 3 is the month 1 visit
  o Visit 4 is the month 2 visit

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  20/NW/0179

• Date of REC Opinion

  6 Apr 2020

• REC opinion

  Favourable Opinion