Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 8
Item
age at least 8
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male or female patient, 8 years (pediatric 8 - 17 years inclusive, adult 18 years)
Item
Male or female patient, 8 years (pediatric 8 - 17 years inclusive, adult 18 years)
boolean
C0079399 (UMLS CUI 2011AA)
263495000 (SNOMED CT 2011_0131)
MTHU002975 (LOINC Version 232)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C1521725 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0700597 (UMLS CUI 2011AA)
41847000 (SNOMED CT 2011_0131)
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)
Item
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)
boolean
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
C1856646 (UMLS CUI 2011AA)
C0031923 (UMLS CUI 2011AA)
372895002 (SNOMED CT 2011_0131)
C0022024 (UMLS CUI 2011AA)
91480001 (SNOMED CT 2011_0131)
99.27 (ICD-9-CM Version 2011)
C0017431 (UMLS CUI 2011AA)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2348519 (UMLS CUI 2011AA)
C0031437 (UMLS CUI 2011AA)
8116006 (SNOMED CT 2011_0131)
Patient is able to perform acceptable spirometric maneuvers according to ATS standards
Item
Patient is able to perform acceptable spirometric maneuvers according to ATS standards
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0037981 (UMLS CUI 2011AA)
127783003 (SNOMED CT 2011_0131)
10041629 (MedDRA 14.1)
FEV1 > 40% predicted and < 90% predicted
Item
FEV1 > 40% predicted and < 90% predicted
boolean
CL414841 (UMLS CUI 2011AA)
C0681842 (UMLS CUI 2011AA)
The patient is clinically stable fulfilling the following: No evidence of acute upper or lower respiratory tract infection within 4 weeks of screening. 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% and -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)
Item
The patient is clinically stable fulfilling the following: No evidence of acute upper or lower respiratory tract infection within 4 weeks of screening. 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% and -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)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0332125 (UMLS CUI 2011AA)
41647002 (SNOMED CT 2011_0131)
C0264222 (UMLS CUI 2011AA)
54398005 (SNOMED CT 2011_0131)
10066679 (MedDRA 14.1)
J06.9 (ICD-10-CM Version 2010)
465.9 (ICD-9-CM Version 2011)
C0238990 (UMLS CUI 2011AA)
195742007 (SNOMED CT 2011_0131)
J22 (ICD-10-CM Version 2010)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1135342 (UMLS CUI 2011AA)
10068288 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0559680 (UMLS CUI 2011AA)
281790008 (SNOMED CT 2011_0131)
C0559681 (UMLS CUI 2011AA)
281791007 (SNOMED CT 2011_0131)
CL426883 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
CL414841 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205541 (UMLS CUI 2011AA)
58334001 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Concomitant or chronic medication is planned to be continued unchanged for the entire study duration
Item
Concomitant or chronic medication is planned to be continued unchanged for the entire study duration
boolean
C2347852 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
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
Item
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
boolean
C0021430 (UMLS CUI 2011AA)
Patient is able to comply with the study visit schedule and willing and able to complete the assessments specified in the protocol.
Item
Patient is able to comply with the study visit schedule and willing and able to complete the assessments specified in the protocol.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C1516048 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
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)
Item
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
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0552536 (UMLS CUI 2011AA)
MTHU002637 (LOINC Version 232)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C1527304 (UMLS CUI 2011AA)
421668005 (SNOMED CT 2011_0131)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C2699424 (UMLS CUI 2011AA)
CL426883 (UMLS CUI 2011AA)
C0017817 (UMLS CUI 2011AA)
55477000 (SNOMED CT 2011_0131)
MTHU006265 (LOINC Version 232)
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.
Item
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
C2347852 (UMLS CUI 2011AA)
CL426883 (UMLS CUI 2011AA)
C0038734 (UMLS CUI 2011AA)
115582009 (SNOMED CT 2011_0131)
MTHU024714 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
C0699252 (UMLS CUI 2011AA)
77731008 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0699252 (UMLS CUI 2011AA)
77731008 (SNOMED CT 2011_0131)
New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.
Item
New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.
boolean
C1718097 (UMLS CUI 2011AA)
MTHU020983 (LOINC Version 232)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
CL426883 (UMLS CUI 2011AA)
C0038734 (UMLS CUI 2011AA)
115582009 (SNOMED CT 2011_0131)
MTHU024714 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
C0699252 (UMLS CUI 2011AA)
77731008 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C2347804 (UMLS CUI 2011AA)
Patient with a known relevant substance abuse, including alcohol or drug abuse.
Item
Patient with a known relevant substance abuse, including alcohol or drug abuse.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
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.
Item
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
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0036864 (UMLS CUI 2011AA)
363903009 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0205173 (UMLS CUI 2011AA)
1305003 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
CL424926 (UMLS CUI 2011AA)
C0024559 (UMLS CUI 2011AA)
399141000 (SNOMED CT 2011_0131)
10065591 (MedDRA 14.1)
63.70 (ICD-9-CM Version 2011)
C0677582 (UMLS CUI 2011AA)
Patient with a documented persistent colonization with B. cepacia (defined as >1 positive culture within the past year).
Item
Patient with a documented persistent colonization with B. cepacia (defined as >1 positive culture within the past year).
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0205322 (UMLS CUI 2011AA)
C2747813 (UMLS CUI 2011AA)
10069718 (MedDRA 14.1)
C0085469 (UMLS CUI 2011AA)
113669008 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C2242979 (UMLS CUI 2011AA)
61594008 (SNOMED CT 2011_0131)
Start of a new concomitant or chronic medication for CF within 4 weeks of screening.
Item
Start of a new concomitant or chronic medication for CF within 4 weeks of screening.
boolean
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
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
Item
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
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
CL031856 (UMLS CUI 2011AA)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
CL428482 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0086960 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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).
Item
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
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C1113679 (UMLS CUI 2011AA)
C1331008 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
Participation in another study with an investigational drug within one month or 6 halflives(whichever is greater) preceding the screening visit.
Item
Participation in another study with an investigational drug within one month or 6 halflives(whichever is greater) preceding the screening visit.
boolean
C0679823 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0018517 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
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.
Item
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
C0599987 (UMLS CUI 2011AA)
224528001 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0021622 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)

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