ID

4914

Description

ODM derived from http://clinicaltrials.gov/show/NCT00506688

Link

http://clinicaltrials.gov/show/NCT00506688

Keywords

  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

April 14, 2014

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT00506688 Cystic Fibrosis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 8
Description

age at least 8

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Male or female patient, 8 years (pediatric 8 - 17 years inclusive, adult 18 years)
Description

Male or female patient, 8 years (pediatric 8 - 17 years inclusive, adult 18 years)

Data type

boolean

Alias
UMLS CUI 2011AA
C0079399
SNOMED CT 2011_0131
263495000
LOINC Version 232
MTHU002975
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C1521725
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0700597
SNOMED CT 2011_0131
41847000
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)
Description

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)

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0010674
SNOMED CT 2011_0131
190905008
MedDRA 14.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
UMLS CUI 2011AA
C1856646
UMLS CUI 2011AA
C0031923
SNOMED CT 2011_0131
372895002
UMLS CUI 2011AA
C0022024
SNOMED CT 2011_0131
91480001
ICD-9-CM Version 2011
99.27
UMLS CUI 2011AA
C0017431
UMLS CUI 2011AA
C0026882
SNOMED CT 2011_0131
55446002
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0010674
SNOMED CT 2011_0131
190905008
MedDRA 14.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2348519
UMLS CUI 2011AA
C0031437
SNOMED CT 2011_0131
8116006
Patient is able to perform acceptable spirometric maneuvers according to ATS standards
Description

Patient is able to perform acceptable spirometric maneuvers according to ATS standards

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0037981
SNOMED CT 2011_0131
127783003
MedDRA 14.1
10041629
FEV1 > 40% predicted and < 90% predicted
Description

FEV1 > 40% predicted and < 90% predicted

Data type

boolean

Alias
UMLS CUI 2011AA
CL414841
UMLS CUI 2011AA
C0681842
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)
Description

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)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0332125
SNOMED CT 2011_0131
41647002
UMLS CUI 2011AA
C0264222
SNOMED CT 2011_0131
54398005
MedDRA 14.1
10066679
ICD-10-CM Version 2010
J06.9
ICD-9-CM Version 2011
465.9
UMLS CUI 2011AA
C0238990
SNOMED CT 2011_0131
195742007
ICD-10-CM Version 2010
J22
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1135342
MedDRA 14.1
10068288
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0559680
SNOMED CT 2011_0131
281790008
UMLS CUI 2011AA
C0559681
SNOMED CT 2011_0131
281791007
UMLS CUI 2011AA
CL426883
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
CL414841
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0205541
SNOMED CT 2011_0131
58334001
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Concomitant or chronic medication is planned to be continued unchanged for the entire study duration
Description

Concomitant or chronic medication is planned to be continued unchanged for the entire study duration

Data type

boolean

Alias
UMLS CUI 2011AA
C2347852
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Patient is able to comply with the study visit schedule and willing and able to complete the assessments specified in the protocol.
Description

Patient is able to comply with the study visit schedule and willing and able to complete the assessments specified in the protocol.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1554962
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
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)
Description

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)

Data type

boolean

Alias
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0552536
LOINC Version 232
MTHU002637
UMLS CUI 2011AA
C0205217
HL7 V3 2006_05
U
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C1527304
SNOMED CT 2011_0131
421668005
MedDRA 14.1
10001718
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C2699424
UMLS CUI 2011AA
CL426883
UMLS CUI 2011AA
C0017817
SNOMED CT 2011_0131
55477000
LOINC Version 232
MTHU006265
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C2347852
UMLS CUI 2011AA
CL426883
UMLS CUI 2011AA
C0038734
SNOMED CT 2011_0131
115582009
LOINC Version 232
MTHU024714
UMLS CUI 2011AA
C0332256
UMLS CUI 2011AA
C0699252
SNOMED CT 2011_0131
77731008
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0699252
SNOMED CT 2011_0131
77731008
New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.
Description

New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.

Data type

boolean

Alias
UMLS CUI 2011AA
C1718097
LOINC Version 232
MTHU020983
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
CL426883
UMLS CUI 2011AA
C0038734
SNOMED CT 2011_0131
115582009
LOINC Version 232
MTHU024714
UMLS CUI 2011AA
C0332256
UMLS CUI 2011AA
C0699252
SNOMED CT 2011_0131
77731008
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C2347804
Patient with a known relevant substance abuse, including alcohol or drug abuse.
Description

Patient with a known relevant substance abuse, including alcohol or drug abuse.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0036864
SNOMED CT 2011_0131
363903009
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0205173
SNOMED CT 2011_0131
1305003
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
CL424926
UMLS CUI 2011AA
C0024559
SNOMED CT 2011_0131
399141000
MedDRA 14.1
10065591
ICD-9-CM Version 2011
63.70
UMLS CUI 2011AA
C0677582
Patient with a documented persistent colonization with B. cepacia (defined as >1 positive culture within the past year).
Description

Patient with a documented persistent colonization with B. cepacia (defined as >1 positive culture within the past year).

Data type

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0205322
UMLS CUI 2011AA
C2747813
MedDRA 14.1
10069718
UMLS CUI 2011AA
C0085469
SNOMED CT 2011_0131
113669008
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C2242979
SNOMED CT 2011_0131
61594008
Start of a new concomitant or chronic medication for CF within 4 weeks of screening.
Description

Start of a new concomitant or chronic medication for CF within 4 weeks of screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205314
SNOMED CT 2011_0131
7147002
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0010674
SNOMED CT 2011_0131
190905008
MedDRA 14.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C1409616
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0205257
SNOMED CT 2011_0131
255599008
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
CL428482
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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).
Description

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).

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0010674
SNOMED CT 2011_0131
190905008
MedDRA 14.1
10011762
LOINC Version 232
MTHU021607
ICD-10-CM Version 2010
E84
ICD-9-CM Version 2011
277.0
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C1113679
UMLS CUI 2011AA
C1331008
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0018939
SNOMED CT 2011_0131
191124002
MedDRA 14.1
10061590
ICD-10-CM Version 2010
D75.9
ICD-9-CM Version 2011
289.9
UMLS CUI 2011AA
C1869009
MedDRA 14.1
20000005
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
Participation in another study with an investigational drug within one month or 6 halflives(whichever is greater) preceding the screening visit.
Description

Participation in another study with an investigational drug within one month or 6 halflives(whichever is greater) preceding the screening visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C0018517
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0599987
SNOMED CT 2011_0131
224528001
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0021622
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008

Similar models

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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