RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2008-005080-33-IT
• Date of registration: 19/01/2009
• Prospective Registration: Yes
• Primary sponsor: AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI
• Public title: RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS
• Scientific title: RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS
• Date of first enrolment: 05/02/2009
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005080-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Italy

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic fibrosis.
MedDRA version: 9.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung

Intervention(s)

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: 10-
Pharmaceutical form of the placebo: Powder for nebuliser solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

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 ID(s)

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