Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
The majority of cystic fibrosis (CF) patients die from a progressive pulmonary disease.Airway
inflammation plays a major role for the pathogenesis of CF lung disease, and ultimately leads
to lung destruction. The release of oxidants during the inflammation process leads to a
chronic imbalance of oxidants and antioxidants and may be a central component leading to
irreversible lung damage in CF patients. The antioxidant glutathione, which is a naturally
occurring tripeptide, is depleted in the extracellular epithelial lining fluid of the CF
lung. The elevation of reduced level to normal and also the augmentation of glutathione
concentrations above the normal level, as observed in smokers and during defence of
Pseudomonas infection, may be desirable to avoid lung damage. Data from pilot studies in
humans and animals have indicated that the glutathione concentrations in epithelial lining
fluid can be elevated by aerosol application.
The main objective of this trial is to evaluate the effect of a 24-week treatment with
inhaled glutathione compared with control inhalations (normal saline) on pulmonary function
in adult and pediatric CF patients. Secondary objectives are to determine the effects of
inhaled glutathione on inflammatory variables, glutathione levels and free elastase in
induced sputum and to evaluate the safety and tolerability of the 24-week treatment with
inhaled GSH.
There is considerable hope within the CF community that the addition of anti-oxidative
therapy to an already comprehensive program for treating the lungs will decrease morbidity
and improve the quality of life for patients with CF.
Phase:
Phase 2
Details
Lead Sponsor:
Mukoviszidose Institut gGmbH
Collaborators:
Cystic Fibrosis Foundation Cystic Fibrosis Foundation Therapeutics