Alpha 1-Antitrypsin Deficiency / Posted 2 years ago

ASTRAEUS: A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo

The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil elastase inhibitor) on blood and sputum biomarkers in patients with Pizz or null genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of different blood and sputum biomarkers related to lung damage, inflammation and elastase activity will be measured over a 12 week period. The effect on lung function and respiratory symptoms will also be measured.

  • Inclusion Criteria :
    • Patients with a confirmed diagnosis of alpha-1-anti-trypsin deficiency and a PiZZ or null geno/phenotype and serum anti-alpha1 antitrypsin levels of less than 11uM
    • FEV1 more than 25% predicted
    • Computerised tomography (CT) scan evidence of emphysema
    • Non-smokers
  • Exclusion Criteria :
    • Primary diagnosis of bronchiectasis
    • An ongoing acute exacerbation of the underlying lung disease
    • Underlying liver disease or abnormal liver function tests
    • Previous augmentation therapy within 6 months of dosing
  • Study start date : 17/08/2018
  • Study end date : un/un/un
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Prof Robert Stockley

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