Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4

• Conditions: Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction.

• Registration Number: EUCTR2005-003870-88-DE
• Lead Sponsor: Mukoviszidose Institut gGmbH i. G.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-28
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Male or female patients older than 8 years (pediatric 8 – 17 years inclusive; adult older than 18 years)

Confirmed diagnosis of CF (positive sweat chloride above 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

Able to perform acceptable spirometric maneuvers, according to ATS standards

FEV1 > 40% predicted and < 90% predicted

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with a significant history of allergy/hypersensitivity (including medication allergy) that is deemed relevant to the trial as judged by the Investigator. Relevance” in this context refers to any increased risk of hypersensitivity reaction to trial medication; there are no specific issues of concern currently identified with respect to use of inhaled glutathione in allergic patients per se

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.

Patients who have participated in another study with an Investigational drug within one month or 6 half-lives (whichever is greater) preceding the screening visit

Patients with known relevant substance abuse, including alcohol or drug abuse. The intention of this criterion is to exclude patients who are considered to be at risk of not complying with or abusing the trial medication administration directives

Female patients of child bearing potential who are sexually active and not using a medically approved form of contraception

Patients with documented persistent colonization with B. cepacia (defined as more than one positive culture within the past year). The intention of this exclusion criterion is to be consistent with the current policy within the CF community for reducing the risk of B. cepacia cross infection

Patients who have started a new chronic medication for CF within 4 weeks of screening.

Patients who are on a cycling medication regimen must have completed at least 3 cycles prior to the screening visit and the medication cycles should be in phase with the follow-up appointments

Clinically significant disease or medical condition 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 significant hematological, hepatic, renal, cardiovascular, and neurologic disease. Patients with diabetes may participate if their disease is under good control prior to screening. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other egibility criteria are satisfied

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified