Cystic fibrosis. MedDRA version: 9.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Conditions
Interventions
Trade Name: TAD 600
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: Glutathione
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed