Status:
UNKNOWN
Inhaled Glutathione (GSH) Versus Placebo in Cystic Fibrosis
Lead Sponsor:
Serafino A. Marsico
Collaborating Sponsors:
Federico II University
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-45 years
Phase:
PHASE3
Brief Summary
Cystic fibrosis (CF) is the most common inherited disease among the Caucasian population with considerable morbidity and reduced life expectancy. Excessive oxidants released by activated inflammatory...
Detailed Description
150 eligible patients will be enrolled on the basis of inclusion criteria. Patients will be divided in two groups: 1) Group 1 age between 6 and 18 years; 2) Group 2 older than 18 years. Patients will ...
Eligibility Criteria
Inclusion
- a confirmed diagnosis of cystic fibrosis documented by sweat chloride test over 60 mmol/L and/or genotype analysis;
- male and female aged older than 6 years;
- stable clinical condition;
- written informed consent.
Exclusion
- pregnancy and fertile women taking oral contraceptives;
- cigarette smoking;
- positive culture for Burkholderia Cepacia;
- history of haemoptysis or pneumothorax;
- FEV1\<= 40% of the predicted value;
- hyperresponsiveness to GSH inhalation test.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01450267
Start Date
June 1 2010
End Date
December 1 2012
Last Update
October 13 2011
Active Locations (1)
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1
Ospedale Monaldi, Azienda Ospedaliera Universitaria Federico II
Naples, Italy