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, null or rare variant phenotype/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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
twice daily administration
twice daily administration
twice daily administration
University of Alabama, Birmingham (UAB)
Birmingham, Alabama, United States
UCLA Medical Center
Los Angeles, California, United States
UC Davis Medical Centre
Sacramento, California, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
The University Lung Clinic
Edmonton, Alberta, Canada
Centre for Heart Lung Innovation, St Pauls Hospital
Vancouver, British Columbia, Canada
Inspiration Research Ltd
Toronto, Ontario, Canada
University of Saskatchewan Royal University Hospital
Saskatoon, Saskatchewan, Canada
...and 16 more locations
Change from baseline on blood biomarkers of neutrophil elastase activity compared to baseline and placebo
Within-individual change from baseline up to end of treatment in: * Blood neutrophil elastase activity * Blood Aα-Val 360 levels * Plasma desmosine/isodesmosine levels
Time frame: 12 weeks
Change from baseline on other blood biomarkers of neutrophil elastase activity
Frequency of neutrophil elastase levels below the limit of detection from baseline to end of treatment
Time frame: 12 weeks
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