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Cystic FibrosisPhase 2NCT00506688

Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients

A Phase 2 study testing reduced glutathione sodium salt in people with Cystic Fibrosis, run by Mukoviszidose Institut gGmbH at 14 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The majority of cystic fibrosis (CF) patients die from a progressive pulmonary disease.Airway inflammation plays a major role for the pathogenesis of CF lung disease, and ultimately leads to lung destruction. Read more about this study

Who is it for?
Ages 8 years and older
Conditions the study is for
Cystic Fibrosis
What is being tested?
reduced glutathione sodium salt
How many people
153 participants
Where
14 sitesGermany
Study dates
Jul 2007to May 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female patient, 8 years (pediatric 8 - 17 years inclusive; adult 18 years)
  • Confirmed diagnosis of CF (positive sweat chloride, 60 mEq/liter by pilocarpine iontophoresis and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype)
  • Patient is able to perform acceptable spirometric maneuvers according to ATS standards
  • FEV1 > 40% predicted and < 90% predicted
  • The patient is clinically stable fulfilling the following:
  • No evidence of acute upper or lower respiratory tract infection within 4 weeks of screening.
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  • No pulmonary exacerbation requiring an use of i.v./oral/inhaled antibiotics, or oral corticosteroids within 4 weeks of screening.
  • FEV1 at Visit 2 is within a range of ± 10% of FEV1 from the Visit 1. (If FEV1 at V2 is not within that range, V2 may be re-scheduled once within 7 days)
  • Concomitant or chronic medication is planned to be continued unchanged for the entire study duration
  • The patient or the patient's legally acceptable representative is able to give informed consent in accordance with ICH and GCP guidelines and local legislation
  • Patient is able to comply with the study visit schedule and willing and able to complete the assessments specified in the protocol.

Who cannot join

  • History of allergy/hypersensitivity (including medication allergy) that is deemed relevant to the trial by the investigator. "Relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication. (Specific concerns currently identified with respect to the use of inhaled glutathione in allergic patients per se are not existing)
  • Concomitant inhaled thiol-containing medications (e.g., inhaled N-acetylcysteine).
  • Such medication had to be finished at least 2 weeks before the screening visit. Oral N-acetylcysteine may be continued.
  • New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.
  • Patient with a known relevant substance abuse, including alcohol or drug abuse.
  • Pregnant or lactating woman or female patient of child bearing potential who is sexually active and not using a medically approved form of contraception such as oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms.
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  • Patient with a documented persistent colonization with B. cepacia (defined as more than one positive culture within the past year).
  • Start of a new concomitant or chronic medication for CF within 4 weeks of screening.
  • Existing cycling medication regimen without completion of at least 3 cycles prior to the screening visit or the drug cycles of other therapies are not in accordance with the 4-week time-schedule for the single visits of this study
  • Clinically relevant diseases or medical conditions other than CF or CF-related conditions that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This includes, but is not limited to, significant hematological, hepatic,renal, cardiovascular, and neurological diseases (diabetic patients may participate if their disease is under good control prior to screening).
  • Participation in another study with an investigational drug within one month or 6 halflives(whichever is greater) preceding the screening visit.
  • The patient is an employee of the investigator or the institution with direct involvement in the trial or other trials under the direction of the investigator or their members.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • Charité Campus Virchow Klinikum,Klinik für Pädiatrie

    Berlin, 13353

  • Universitätskinderklinink

    Bochum, 44791

  • Uniklinik Köln Mukoviszidose Zentrum

    Cologne, D-50924

  • Ruhrlandklinink

    Essen, 45239

  • CF-Ambulanz/ Universitätsklinikum Essen

    Essen, D-45128

  • CF-Ambulanz Frankfurt

    Frankfurt, D-60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79104

  • Gemeinschaftspraxis CF Ambulanz

    Hamburg, 22763

  • Med. Hochschule Hannover

    Hanover, 30625

  • MHH Kinderklinik CF-Ambulanz

    Hanover, D-30625

  • Universitätsklinik

    Leipzig, 04109

  • Klinikum Innenstadt, Medizinische Klinik / Pneumologie

    München, 80336

  • CF-Amulanz/ Dr.von Haunersches Kinderspital

    Munich, D-80337

  • Clemenshospital GmbH,Akademisches Lehrkrankenhaus der Westfälischen Wildhelms-Universität Münster

    Münster, 48153

Other trials in Germany

About this study

Official title: Randomized, Placebo-controlled, Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis Patients

The majority of cystic fibrosis (CF) patients die from a progressive pulmonary disease.Airway inflammation plays a major role for the pathogenesis of CF lung disease, and ultimately leads to lung destruction. The release of oxidants during the inflammation process leads to a chronic imbalance of oxidants and antioxidants and may be a central component leading to irreversible lung damage in CF patients. The antioxidant glutathione, which is a naturally occurring tripeptide, is depleted in the extracellular epithelial lining fluid of the CF lung. The elevation of reduced level to normal and also the augmentation of glutathione concentrations above the normal level, as observed in smokers and during defence of Pseudomonas infection, may be desirable to avoid lung damage. Data from pilot studies in humans and animals have indicated that the glutathione concentrations in epithelial lining fluid can be elevated by aerosol application.

The main objective of this trial is to evaluate the effect of a 24-week treatment with inhaled glutathione compared with control inhalations (normal saline) on pulmonary function in adult and pediatric CF patients. Secondary objectives are to determine the effects of inhaled glutathione on inflammatory variables, glutathione levels and free elastase in induced sputum and to evaluate the safety and tolerability of the 24-week treatment with inhaled GSH.

There is considerable hope within the CF community that the addition of anti-oxidative therapy to an already comprehensive program for treating the lungs will decrease morbidity and improve the quality of life for patients with CF.

Conditions
Cystic Fibrosis
Being tested
reduced glutathione sodium salt, 0.9% normal saline (control)
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • reduced glutathione sodium saltDrug

    Also called TAD 600

    646 mg GSH-Na powder per vial to prepare a 4ml solution, twice daily for 24 weeks.

  • 0.9% normal saline (control)Drug

    4 ml of a 0.9% normal saline solution (9mg/ml NaCl), twice daily for 24 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences between inhaled glutathione and inhaled normal saline with respect to the area under the curve of FEV1 % predicted (forced expiratory volume in 1 second) within the period from baseline to week 24 (V5, EOT)

    Measured: 24 weeks

Secondary outcomes (1)

  1. Treatment changes with respect to the variables:Spirometry,Peak flow,quality-of-life,Weight/ height,Percentage of neutrophils/other cell types (induced sputum),Induced sputum levels of glutathione/ inflammatory mediators,Pulmonary exacerbation

    Measured: 0,4, 12, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00506688
Sponsor's protocol ID
Muko-D-GSH-4
Other IDs
EudraCT-number: 2005-003870-88
Status last verified
Jul 2012
First submitted
24 Jul 2007
Last updated
10 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Griese M, Kappler M, Eismann C, Ballmann M, Junge S, Rietschel E, van Koningsbruggen-Rietschel S, Staab D, Rolinck-Werninghaus C, Mellies U, Kohnlein T, Wagner T, Konig S, Teschler H, Heuer HE, Kopp M, Heyder S, Hammermann J, Kuster P, Honer M, Mansmann U, Beck-Speier I, Hartl D, Fuchs C; Glutathione Study Group; Hector A. Inhalation treatment with glutathione in patients with cystic fibrosis. A randomized clinical trial. Am J Respir Crit Care Med. 2013 Jul 1;188(1):83-9. doi: 10.1164/rccm.201303-0427OC.

    PubMed 23631796

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing reduced glutathione sodium salt in people with Cystic Fibrosis, run by Mukoviszidose Institut gGmbH at 14 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences between inhaled glutathione and inhaled normal saline with respect to the area under the curve of FEV1 % predicted (forced expiratory volume in 1 second) within the period from baseline to week 24 (V5, EOT) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00506688, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.

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