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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01450267 |
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Date of registration:
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30/09/2011 |
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Primary sponsor: |
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Public title:
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Inhaled Glutathione (GSH) Versus Placebo in Cystic Fibrosis
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Scientific title:
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Randomized, Single Blind, Controlled Trial of Inhaled Glutathione Versus Placebo in Patients With Cystic Fibrosis |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01450267 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Valeria Raia, Prof |
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Address:
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Telephone:
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Email:
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raia@unina.it |
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Affiliation:
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Name:
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CECILIA CALABRESE, DR |
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Address:
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Telephone:
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00390817062365 |
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Email:
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cecilia.calabrese@unina2.it |
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Affiliation:
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Name:
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Serafino A Marsico, PROF |
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Address:
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Telephone:
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Email:
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Affiliation:
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Second University of Naples |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
6 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Inhaled Reduced Glutathione
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Drug: Physiological solution
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Primary Outcome(s)
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Forced expiratory volume in one second (FEV1) percent
[Time Frame: 12 months]
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Secondary Outcome(s)
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BMI
[Time Frame: 12 months]
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Cough
[Time Frame: 12 months]
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Dyspnoea
[Time Frame: 12 months]
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Epithelial inflammatory markers on brushed nasal epithelial cells
[Time Frame: 12 months]
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Exercise Capacity
[Time Frame: 12 months]
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Markers of oxidative stress (H2O2)in serum and in exhaled breath condensate (EBC)
[Time Frame: 12 months]
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Pulmonary exacerbations
[Time Frame: 12 months]
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Quality of life
[Time Frame: 12 months]
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Small airway function
[Time Frame: 12 months]
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Secondary ID(s)
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FARM7K7XZB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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