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Study · Randomized controlled trial · n = 105 · 2015

4 results

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

Calabrese C, Tosco A, Abete P, Carnovale V, Basile C, Magliocca A, Quattrucci S, De Sanctis S, Alatri F, Mazzarella G, De Pietro L, Turino C and 4 more

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Melillo E, Buonpensiero P, Di Pasqua A, Raia V

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society4 Nov 2014Cited by 22 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In cystic fibrosis, inhaled GSH did not achieve the predetermined 15% improvement in FEV1%.

    In plain wordsIn cystic fibrosis, inhaled GSH did not reach the prespecified lung function improvement target.

    Outcome
    Direction not reportedFEV1 primary target
    Study

    n = 105

    Analysis
    Primary
    Outcome group
    Respiratory function · Respiratory
    Studied dose
    Dose not stated · inhaled · 12 monthsAs given in this study (human).

    Measurements

    Predetermined FEV1% improvement threshold
    15%
    Primary outcome threshold not achieved after 12 months of inhaled GSH

    Source sentences

    Summary
    Twelve month treatment with inhaled GSH did not achieve our predetermined primary outcome measure of 15% improvement in FEV1%.
    2 context sentences
    Summary · context
    The aim of this single-blind, randomized, placebo-controlled trial was to evaluate the effect of inhaled GSH in patients with CF.
    Summary · context
    54 adult and 51 pediatric patients were randomized to receive inhaled GSH or placebo twice daily for 12 months.
  2. 02HumanRandomized controlled trialSafety outcome

    In cystic fibrosis, all patients tolerated inhaled GSH well.

    In plain wordsIn cystic fibrosis, all patients tolerated inhaled GSH well.

    Outcome
    Not applicableTolerability
    Study

    n = 105

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · inhaled · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    GSH was well tolerated by all patients.
    2 context sentences
    Summary · context
    The aim of this single-blind, randomized, placebo-controlled trial was to evaluate the effect of inhaled GSH in patients with CF.
    Summary · context
    54 adult and 51 pediatric patients were randomized to receive inhaled GSH or placebo twice daily for 12 months.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In pediatric cystic fibrosis, inhaled GSH improved the 6-minute walking test.

    In plain wordsIn children with cystic fibrosis, inhaled GSH improved walking test performance.

    Outcome
    Increase6-minute walking test in children
    Study

    n = 51

    Outcome group
    Exercise and physical function · Respiratory
    Studied dose
    Dose not stated · inhaled · 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Moreover GSH therapy improved 6-minute walking test in pediatric population.
    2 context sentences
    Summary · context
    The aim of this single-blind, randomized, placebo-controlled trial was to evaluate the effect of inhaled GSH in patients with CF.
    Summary · context
    54 adult and 51 pediatric patients were randomized to receive inhaled GSH or placebo twice daily for 12 months.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In cystic fibrosis with moderate lung disease, GSH increased FEV1 from baseline at 3, 6 and 9 months.

    In plain wordsIn cystic fibrosis with moderate lung disease, GSH improved lung function compared with baseline.

    Outcome
    IncreaseFEV1 in moderate lung disease
    Study

    n: not reported in source

    Outcome group
    Respiratory function · Respiratory
    Studied dose
    Dose not stated · inhaled · 3, 6 and 9 monthsAs given in this study (human).

    Source sentences

    Summary
    Only in patients with moderate lung disease, 3, 6 and 9 months therapy with GSH resulted in a statistically significant increase of FEV1 values from the baseline.
    2 context sentences
    Summary · context
    The aim of this single-blind, randomized, placebo-controlled trial was to evaluate the effect of inhaled GSH in patients with CF.
    Summary · context
    54 adult and 51 pediatric patients were randomized to receive inhaled GSH or placebo twice daily for 12 months.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 3NCT01450267

Inhaled Glutathione (GSH) Versus Placebo in Cystic Fibrosis

Serafino A. Marsicon = 150Jun 2010 to est. Dec 2012

Cystic Fibrosis

Trial pageClinicalTrials.govUpdated 13 Oct 2011

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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