Inhalation treatment with glutathione in patients with cystic fibrosis. A randomized clinical trial.

Griese M, Kappler M, Eismann C, Ballmann M, Junge S, Rietschel E, van Koningsbruggen-Rietschel S, Staab D, Rolinck-Werninghaus C, Mellies U, Köhnlein T, Wagner T and 13 more

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König S, Teschler H, Heuer HE, Kopp M, Heyder S, Hammermann J, Küster P, Honer M, Mansmann U, Beck-Speier I, Hartl D, Fuchs C, Hector A

American journal of respiratory and critical care medicine1 Jul 2013Cited by 67 (Europe PMC)

PMID23631796DOI10.1164/rccm.201303-0427ocPepBankPUB-23631796

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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 study12

12 results from studies that gave the peptide. 12 results from people.

01HumanRandomized controlled trialEfficacy outcome
In cystic fibrosis, glutathione did not significantly change the FEV1 pre-post difference versus placebo over the treatment period.
In plain wordsIn cystic fibrosis, glutathione did not significantly change the FEV1 pre-post difference versus placebo.
Peptide
Glutathione
Outcome
No significant changeFEV1 pre-post difference
Study
n = 153
Comparator
Placebo
Analysis
Primary
Outcome group
Respiratory function · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Measurements
P value
0.18
FEV1 pre-post difference
Source sentences
Summary
FEV1 (absolute values), both as pre-post differences (P = 0.180) and as area under the curves (P = 0.205), were the primary efficacy endpoints, and were not different between the glutathione group and the placebo group over the 6-month treatment period.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179601
02HumanRandomized controlled trialEfficacy outcome
In cystic fibrosis, glutathione did not significantly change FEV1 area under the curve versus placebo.
In plain wordsIn cystic fibrosis, glutathione did not significantly change FEV1 area under the curve versus placebo.
Peptide
Glutathione
Outcome
No significant changeFEV1 area under the curve
Study
n = 153
Comparator
Placebo
Analysis
Primary
Outcome group
Respiratory function · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Measurements
P value
0.205
FEV1 area under the curve
Source sentences
Summary
FEV1 (absolute values), both as pre-post differences (P = 0.180) and as area under the curves (P = 0.205), were the primary efficacy endpoints, and were not different between the glutathione group and the placebo group over the 6-month treatment period.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179602
03HumanRandomized controlled trialEfficacy outcome
In cystic fibrosis, glutathione increased FEV1 over placebo at 3 months, but the increase was not significant later.
In plain wordsIn cystic fibrosis, glutathione improved lung function more than placebo at 3 months, but not significantly later.
Peptide
Glutathione
Outcome
MixedExploratory FEV1 change
Study
n = 153
Comparator
Placebo
Analysis
Exploratory
Outcome group
Respiratory function · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Measurements
FEV1 increase
100 ml
over placebo
FEV1 increase
2.2 % predicted
over placebo
Source sentences
Summary
Exploratory analysis showed an increase of FEV1 from baseline over placebo of 100 ml or 2.2% predicted; this was significant at 3 months, but not later.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179603
04HumanRandomized controlled trialEfficacy outcome
In cystic fibrosis, glutathione did not reduce pulmonary exacerbations versus placebo.
In plain wordsIn cystic fibrosis, glutathione did not reduce pulmonary exacerbations versus placebo.
Peptide
Glutathione
Outcome
No significant changePulmonary exacerbations
Study
n = 153
Comparator
Placebo
Outcome group
Respiratory function · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Source sentences
Summary
Subjects receiving glutathione had neither fewer pulmonary exacerbations, nor better scores for quality of life.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179604
05HumanRandomized controlled trialEfficacy outcome
In cystic fibrosis, glutathione did not improve quality of life scores versus placebo.
In plain wordsIn cystic fibrosis, glutathione did not improve quality of life scores versus placebo.
Peptide
Glutathione
Outcome
No significant changeQuality of life
Study
n = 153
Comparator
Placebo
Outcome group
Quality of life · Whole body
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Source sentences
Summary
Subjects receiving glutathione had neither fewer pulmonary exacerbations, nor better scores for quality of life.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179605
06HumanRandomized controlled trialSafety outcome
In cystic fibrosis, adverse event incidence was similar with glutathione and placebo.
In plain wordsIn cystic fibrosis, adverse events occurred at similar rates with glutathione and placebo.
Peptide
Glutathione
Outcome
No significant changeAdverse event incidence
Study
n = 153
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Source sentences
Summary
The adverse event incidence was similar between glutathione and placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179612
07HumanRandomized controlled trialPharmacokinetics
In cystic fibrosis, increased sputum glutathione demonstrated delivery of inhaled glutathione to the lungs.
In plain wordsIn cystic fibrosis, inhaled glutathione increased glutathione in sputum, showing delivery to the lungs.
Peptide
Glutathione
Outcome
IncreaseSputum glutathione
Study
n: not reported in source
Outcome group
Pharmacokinetics · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Source sentences
Summary
Whereas increased glutathione and metabolites in sputum demonstrated significant delivery to the lungs
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179606
08HumanRandomized controlled trialPharmacokinetics
In cystic fibrosis, increased sputum glutathione metabolites demonstrated delivery of inhaled glutathione to the lungs.
In plain wordsIn cystic fibrosis, inhaled glutathione increased its metabolites in sputum, showing delivery to the lungs.
Peptide
Glutathione
Outcome
IncreaseSputum glutathione metabolites
Study
n: not reported in source
Outcome group
Pharmacokinetics · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Source sentences
Summary
Whereas increased glutathione and metabolites in sputum demonstrated significant delivery to the lungs
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179607
09HumanRandomized controlled trialMechanism
In cystic fibrosis, inhaled glutathione showed no indication of diminished oxidative stress to proteins.
In plain wordsIn cystic fibrosis, inhaled glutathione showed no indication of reduced oxidative damage to proteins.
Peptide
Glutathione
Outcome
No significant changeProtein oxidative stress
Study
n: not reported in source
Outcome group
Oxidative stress · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Source sentences
Summary
there was no indication of diminished oxidative stress to proteins or lipids
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179608
10HumanRandomized controlled trialMechanism
In cystic fibrosis, inhaled glutathione showed no indication of diminished oxidative stress to lipids.
In plain wordsIn cystic fibrosis, inhaled glutathione showed no indication of reduced oxidative damage to lipids.
Peptide
Glutathione
Outcome
No significant changeLipid oxidative stress
Study
n: not reported in source
Outcome group
Oxidative stress · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Source sentences
Summary
there was no indication of diminished oxidative stress to proteins or lipids
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179609
11HumanRandomized controlled trialMechanism
In cystic fibrosis, airway glutathione supplementation showed no evidence of anti-inflammatory action.
In plain wordsIn cystic fibrosis, airway glutathione supplementation showed no evidence of reduced inflammation.
Peptide
Glutathione
Outcome
No significant changeAnti-inflammatory action
Study
n: not reported in source
Outcome group
Inflammation markers · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Source sentences
Summary
and no evidence for anti-inflammatory or antiproteolytic actions of glutathione supplemented to the airways.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179610
12HumanRandomized controlled trialMechanism
In cystic fibrosis, airway glutathione supplementation showed no evidence of antiproteolytic action.
In plain wordsIn cystic fibrosis, airway glutathione supplementation showed no evidence of reduced protein breakdown.
Peptide
Glutathione
Outcome
No significant changeAntiproteolytic action
Study
n: not reported in source
Outcome group
Receptor activity and mechanism · Respiratory
Studied dose
646 mg every 12 hours · inhalation via eFlow nebulizer · 6 monthsAs given in this study (human).
Source sentences
Summary
and no evidence for anti-inflammatory or antiproteolytic actions of glutathione supplemented to the airways.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled trial evaluated inhaled glutathione in subjects with CF 8 years of age and older and FEV1 of 40-90% of predicted.
Summary · context
Subjects were randomized to receive 646 mg glutathione in 4 ml (n = 73) or placebo (n = 80) via an investigational eFlow nebulizer every 12 hours for 6 months.
Report a problemFND-2363179611

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

CompletedPhase 2NCT00506688

Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients

Mukoviszidose Institut gGmbHn = 153Jul 2007 to May 2010

Cystic Fibrosis

Trial page ClinicalTrials.govUpdated 10 Jul 2012

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.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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