Exclusion Criteria
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)
boolean
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.
boolean
New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.
boolean
Patient with a known relevant substance abuse, including alcohol or drug abuse.
boolean
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.
boolean
Patient with a documented persistent colonization with B. cepacia (defined as >1 positive culture within the past year).
boolean
Start of a new concomitant or chronic medication for CF within 4 weeks of screening.
boolean
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
boolean
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).
boolean
Participation in another study with an investigational drug within one month or 6 halflives(whichever is greater) preceding the screening visit.
boolean
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.
boolean