Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506688
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2007-07-24
Brief Title:
Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients
Sponsor:
Mukoviszidose Institut gGmbH
Organization:
Mukoviszidose Institut gGmbH
Study Overview
Official Title:
Randomized Placebo-controlled Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis Patients
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The majority of cystic fibrosis CF patients die from a progressive pulmonary diseaseAirway 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT-number 2005-003870-88 | None | None | None |