RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS
- Conditions
- Cystic fibrosis.MedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung
- Registration Number
- EUCTR2008-005080-33-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1) a confirmed diagnosis of Cystic Fibrosis documented by sweat chloride test over 60 mmol/L and/or genotype analysis; 2) male and female aged older than 6 years; 3) stable clinical condition; 4) written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1) pregnancy and fertile women taking oral contraceptives; 2) cigarette smoking; 3) positive culture for Burkholderia Cepacia; 4) history of haemoptysis or pneumotorax; 5) FEV1<= 40% of the predicted value; 6) hyperresponsiveness to GSH inhalation test.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether a 12 months treatment with inhaled GSH, in addition to an individual titrated therapy, can improve the degree of airway obstruction in Cystic Fibrosis patients.;Secondary Objective: To evaluate the effects of GSH therapy on other clinical, functional, and biological parameters: 1)respiratory symptoms (dyspnoea and cough); 2)quality of life; 3)frequency of pulmonary exacerbations, hospital admissions, and parenteral antibiotic administration; 4)inspiratory capacity (IC), FEF 25-75; 5)6 minute walk test; 6)body mass index(BMI); 7)markers of oxidative stress in serum and EBC(exhaled breath condensate)and epithelial inflammatory markers on brushed nasal epithelial cells.;Primary end point(s): Increase from baseline in percent FEV1 of at least 15% in patients treated with inhaled GSH for 12 months compared to placebo.
- Secondary Outcome Measures
Name Time Method