EUCTR2005-003870-88-DEActive, not recruitingNot Applicable
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
Mukoviszidose Institut gGmbH i. G.0 sites160 target enrollmentStarted: August 28, 2006Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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