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Trial · Interventional

Status unknownPhase 3Registry data

Inhaled Glutathione (GSH) Versus Placebo in Cystic Fibrosis

NCTNCT01450267 (opens ClinicalTrials.gov in a new tab)Other idFARM7K7XZB
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
150 participants (estimated)
Sponsor
Serafino A. Marsico · Other
Design
Randomized · Single masking
Countries
1 country

Italy

Start
Jun 2010
Primary completion
May 2012 (estimated)
Completion
Dec 2012 (estimated)
First posted
12 Oct 2011 (estimated)
Last update posted
13 Oct 2011 (estimated)
Conditions
Cystic Fibrosis

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 3

    Inhaled Glutathione (GSH) Versus Placebo in Cystic Fibrosis

    NCT01450267

    Jun 2010 to est. Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 cells and persisting infections are considered the main mechanism of damage of respiratory epithelium in CF.Glutathione (GSH) represents the first-line defence of the lung against oxidative stress-induced cell injury; however, a depletion of its levels has been observed in the airways of patients affected by CF. In vitro studies have showed that CFTR protein plays a pivotal role in transmembrane glutathione transport. Therapeutic approaches with inhaled GSH could improve the reduced lung antioxidant capacity in order to counterbalance the oxidant stress linked to the chronic airway inflammation and bacterial infection. Primary objective of the study is to investigate whether a 12 months treatment with inhaled GSH can improve airway obstruction in CF patients. Secondary objectives include the effects of GSH therapy on exercise capacity, body mass index (BMI), respiratory symptoms, quality of life, frequency of pulmonary exacerbations, hospital admissions, and antibiotic administration. Moreover the study will evaluate the effect of GSH therapy on markers of oxidative stress in exhaled breath condensate (EBC) and in serum, and on inflammatory markers on brushed nasal epithelial cells.

Interventions

  • Inhaled Reduced GlutathioneDrug
  • Physiological solutionDrug

Arms2

  • Placebo comparator

    Physiological solution

  • Experimental

    Reduced Inhaled Glutathione

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Forced expiratory volume in one second (FEV1) percent

    Time frame · 12 months

    Registry description

    Increase of at least 15% of the percent of forced expiratory volume in one second (FEV1) after GSH therapy compared to placebo

Secondary outcomes(9)

  1. Small airway function

    Time frame · 12 months

    Registry description

    It will be assessed by the flow volume curve and it will bealso evaluated after 1,3,6,and 9 months from the beginning of the treatments and after 1, 3, and 6 months from the end of the treatments

  2. Exercise Capacity

    Time frame · 12 months

    Registry description

    It will be measured by the six minutes walking test and it will be also evaluated after 1,3,6, and 9 months from the beginning of the treatments and after 1, 3, and 6 months from the end of the treatments

  3. BMI

    Time frame · 12 months

    Registry description

    It will be also evaluated after 1,3,6, and 9 months from the beginning of the treatments and after 1, 3, and 6 months from the end of the treatments

  4. Dyspnoea

    Time frame · 12 months

    Registry description

    It will be assessed through the Modified Medical Research Council (MMRC) dyspnoea scale and it will be also evaluated after 1,3,6, and 9 months from the beginning of the treatments and after 1, 3, and 6 months from the end of the treatments

  5. Cough

    Time frame · 12 months

    Registry description

    It will be assessed by the Chronic Cough Impact Questionnaire (CCIQ)and it will be also evaluated after 1,3,6, and 9 months from the beginning of the treatments and after 1, 3, and 6 months from the end of the treatments

  6. Quality of life

    Time frame · 12 months

    Registry description

    It will be assessed according to Cystic Fibrosis Quality of Life Questionnaire (CFQoL) (not for children 6-13 years old)and it will be also evaluated after 1,3,6, and 9 months from the beginning of the treatments and after 1, 3, and 6 months from the end of the treatments

  7. Pulmonary exacerbations

    Time frame · 12 months

    Registry description

    It will be assessed evaluating the hospital admissions and antibiotic administrations. It will be also evaluated after 1,3,6, and 9 months from the beginning of the treatments and after 1, 3, and 6 months from the end of the treatments

  8. Markers of oxidative stress (H2O2)in serum and in exhaled breath condensate (EBC)

    Time frame · 12 months

    Registry description

    It will be measured at baseline, in the middle and at the end of the study

  9. Epithelial inflammatory markers on brushed nasal epithelial cells

    Time frame · 12 months

    Registry description

    Epithelial tyrosine phosphorylation, p38-MAPK phosphorylation, TNF alfa release will be evaluated at baseline, in the middle and at the end of the study

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2015

4 results

Randomized, single blind, controlled trial of inhaled glutathione vs placebo in patients with cystic fibrosis.

Calabrese et al. 2015Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Societycited by 22

PMID 25458463DOI 10.1016/j.jcf.2014.09.014PUB-25458463

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2004

8 results

Improvement of alveolar glutathione and lung function but not oxidative state in cystic fibrosis.

Griese et al. 2004American journal of respiratory and critical care medicinecited by 77

PMID 14726422DOI 10.1164/rccm.200308-1104ocPUB-14726422

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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