ID

43074

Description

ODM derived from http://clinicaltrials.gov/show/NCT00640016

Link

http://clinicaltrials.gov/show/NCT00640016

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 8/8/14 8/8/14 - Martin Dugas
  3. 5/22/15 5/22/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
age 18 Years to 80 Years
Description

age 18 Years to 80 Years

Data type

boolean

Alias
SNOMED CT 2011_0131
397669002
UMLS CUI-1
C0001779
Informed consent
Description

Signed and dated written informed consent is obtained prior to any study related procedure taking place.

Data type

boolean

Alias
SNOMED CT 2011_0131
410671006
LOINC Version 232
MTHU021546
HL7 V3 2006_05
WRITTEN
SNOMED CT 2011_0131-2
288556008
UMLS CUI-1
C0021430
Female infertility or Contraceptive methods
Description

Women either infertile (e.g. hysterectomised, sterile or post menopausal with amenorrhoea of least one year duration) or who are practicing an acceptable form of birth control (contraceptive pill or double-barrier contraception)

Data type

boolean

Alias
SNOMED CT 2011_0131
224526002
SNOMED CT 2011_0131-2
8619003
MedDRA 14.1
10021926
SNOMED CT 2011_0131-3
236886002
MedDRA 14.1-2
10021151
SNOMED CT 2011_0131-4
76498008
SNOMED CT 2011_0131-5
14302001
MedDRA 14.1-3
10001928
ICD-10-CM Version 2010
N91.2
ICD-9-CM Version 2011
626.0
SNOMED CT 2011_0131-6
258707000
HL7 V3 2006_05
Y
SNOMED CT 2011_0131-7
146680009
MedDRA 14.1-4
10010808
SNOMED CT 2011_0131-8
59261009
SNOMED CT 2011_0131-9
225370004
SNOMED CT 2011_0131-10
1305003
UMLS CUI-1
C0021361
UMLS CUI-2
C0700589
partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge) for 1 month prior to Visit 1 (screening visit) or longer if requested by the investigator. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study. Women of childbearing potential must have a negative pregnancy test at screening and Visit 2, 5, 7 and 9.
Description

partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge) for 1 month prior to Visit 1 (screening visit) or longer if requested by the investigator. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study. Women of childbearing potential must have a negative pregnancy test at screening and Visit 2, 5, 7 and 9.

Data type

boolean

Alias
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
SNOMED CT 2011_0131-2
260676000
SNOMED CT 2011_0131-3
260676000
SNOMED CT 2011_0131-4
425484006
SNOMED CT 2011_0131-5
20359006
SNOMED CT 2011_0131-6
268460000
MedDRA 14.1
10022745
SNOMED CT 2011_0131-7
169529008
SNOMED CT 2011_0131-8
258706009
HL7 V3 2006_05-2
MO
SNOMED CT 2011_0131-9
288556008
HL7 V3 2006_05-3
ENC
SNOMED CT 2011_0131-10
242762006
SNOMED CT 2011_0131-11
385644000
SNOMED CT 2011_0131-12
224526002
SNOMED CT 2011_0131-13
146680009
MedDRA 14.1-2
10010808
SNOMED CT 2011_0131-14
371881003
SNOMED CT 2011_0131-15
110465008
SNOMED CT 2011_0131-16
19338005
SNOMED CT 2011_0131-17
258706009
HL7 V3 2006_05-4
MO
SNOMED CT 2011_0131-18
237679004
SNOMED CT 2011_0131-19
250425007
MedDRA 14.1-3
10036574
HL7 V3 2006_05-5
ENC
UMLS CUI-1
C0700589
Uncontrolled (refractory) asthma despite optimal treatment
Description

Uncontrolled (refractory) asthma despite optimal treatment

Data type

boolean

Alias
SNOMED CT 2011_0131
19032002
SNOMED CT 2011_0131-2
20646008
SNOMED CT 2011_0131-3
195967001
MedDRA 14.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
SNOMED CT 2011_0131-4
439401001
LOINC Version 232-2
MTHU008876
SNOMED CT 2011_0131-5
65897001
UMLS CUI-1
C0581126
subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 g beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
Description

subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 g beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.

Data type

boolean

Alias
UMLS CUI-1
C3862402
UMLS CUI-2
C0004906
UMLS CUI-3
C3248292
UMLS CUI-4
C0001644
UMLS CUI-5
C0039771
UMLS CUI-6
C0595726
UMLS CUI-7
C0205360
UMLS CUI-8
C0205195
A forced expiratory volume in 1 second (FEV1) acceptable for AHR challenge tests (>= 60% of predicted normal) on the challenge days.
Description

A forced expiratory volume in 1 second (FEV1) acceptable for AHR challenge tests (>= 60% of predicted normal) on the challenge days.

Data type

boolean

Alias
UMLS CUI-1
C0849974
UMLS CUI-2
C2733011
A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.
Description

A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.

Data type

boolean

Alias
UMLS CUI 2015AA
C1714622
Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.
Description

Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.

Data type

boolean

Alias
UMLS CUI 2015AA
C0001779
UMLS CUI 2015AA-2
C0439841
UMLS CUI 2011AA
C0522054
Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.
Description

Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.

Data type

boolean

Alias
UMLS CUI 2015AA
C0438214
Body weight (observable entity)
Description

Body weight of <= 130 kg.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).
Description

No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).

Data type

boolean

Alias
UMLS CUI 2015AA
C2063084
Able to comply with the requirements of the protocol.
Description

Able to comply with the requirements of the protocol.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA-2
C1321605
SNOMED CT 2011_0131-2
405078008
UMLS CUI 2011AA-3
C1709747
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
C0680251
Experienced a severe exacerbation within 28 days preceding Visit 1.
Description

Experienced a severe exacerbation within 28 days preceding Visit 1.

Data type

boolean

Alias
UMLS CUI 2015AA
C0038218
UMLS CUI 2015AA-2
C3828653
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
Description

Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.

Data type

boolean

Alias
UMLS CUI 2015AA
C0018621
UMLS CUI 2015AA-2
C1821205
UMLS CUI 2015AA-3
C3828653
Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.
Description

Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.

Data type

boolean

Alias
UMLS CUI 2015AA
C2348568
Lower respiratory tract infection within six weeks of Visit 1.5.
Description

Lower respiratory tract infection within six weeks of Visit 1.5.

Data type

boolean

Alias
UMLS CUI 2011AA
C0149725
SNOMED CT 2011_0131
50417007
MedDRA 14.1
10024968
UMLS CUI 2011AA-2
C0439230
SNOMED CT 2011_0131-2
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA-3
C1512346
HL7 V3 2006_05-2
ENC
Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
Description

Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).

Data type

boolean

Alias
SNOMED CT 2011_0131
77176002
MedDRA 14.1
10048880
SNOMED CT 2011_0131-2
8517006
MedDRA 14.1-2
10015572
SNOMED CT 2011_0131-3
315609007
SNOMED CT 2011_0131-4
260299005
LOINC Version 232
MTHU024869
SNOMED CT 2011_0131-5
258703001
HL7 V3 2006_05
D
SNOMED CT 2011_0131-6
258707000
HL7 V3 2006_05-2
Y
UMLS CUI-1
C0337664
UMLS CUI-2
C0337671
UMLS CUI-3
C1277691
Blood donation (> 550 mL) in the previous two months.
Description

Blood donation (> 550 mL) in the previous two months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005794
SNOMED CT 2011_0131
25179006
UMLS CUI 2011AA-2
C0205156
SNOMED CT 2011_0131-2
9130008
UMLS CUI 2011AA-3
C0205448
SNOMED CT 2011_0131-3
19338005
UMLS CUI 2011AA-4
C0439231
SNOMED CT 2011_0131-4
258706009
HL7 V3 2006_05
MO
Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.
Description

Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.

Data type

boolean

Alias
SNOMED CT 2011_0131
160592001
SNOMED CT 2011_0131-2
61254005
SNOMED CT 2011_0131-3
18669006
SNOMED CT 2011_0131-4
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
SNOMED CT 2011_0131-5
61010005
SNOMED CT 2011_0131-6
417928002
MedDRA 14.1-2
10000341
UMLS CUI-1
C1705534
UMLS CUI-2
C0001948
Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis.
Description

Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis.

Data type

boolean

Alias
UMLS CUI-1
C0024115
UMLS CUI-2
C0750502
Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.
Description

Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.

Data type

boolean

Alias
SNOMED CT 2011_0131
68405009
HL7 V3 2006_05
ENC
LOINC Version 232
MTHU024501
UMLS CUI-1
C0013227
UMLS CUI-2
C3242263
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
Description

Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI 2015AA
C0184774
hypertension heart disease, psoriasis or stroke
Description

systolic blood pressure > 200 mmHg, or diastolic blood pressure > 100 mmHg, heart disease, psoriasis requiring treatment and subjects who have had a heart attack or stroke within the 3 months preceding Visit 1, or who have a known aneurysm.

Data type

boolean

Alias
UMLS CUI-1
C0020538
UMLS CUI-2
C0033860
UMLS CUI-3
C0038454
Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).
Description

Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).

Data type

boolean

Alias
UMLS CUI 2015AA
C3844688
The subject's primary care physician recommends the subject should not take part in the study.
Description

The subject's primary care physician recommends the subject should not take part in the study.

Data type

boolean

Alias
SNOMED CT 2011_0131
446050000, 59058001
LOINC Version 232
MTHU036724
HL7 V3 2006_05
RMD
SNOMED CT 2011_0131-2
116154003
HL7 V3 2006_05-2
PART
SNOMED CT 2011_0131-3
110465008
UMLS CUI-1
C0017319
UMLS CUI-2
C3242266
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
Description

Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.

Data type

boolean

Alias
UMLS CUI 2015AA
C0020517
UMLS CUI 2015AA-2
C0013227
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age 18 Years to 80 Years
Item
age 18 Years to 80 Years
boolean
397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
Informed consent
Item
Informed consent
boolean
410671006 (SNOMED CT 2011_0131)
MTHU021546 (LOINC Version 232)
WRITTEN (HL7 V3 2006_05)
288556008 (SNOMED CT 2011_0131-2)
C0021430 (UMLS CUI-1)
Female infertility or Contraceptive methods
Item
Female infertility or Contraceptive methods
boolean
224526002 (SNOMED CT 2011_0131)
8619003 (SNOMED CT 2011_0131-2)
10021926 (MedDRA 14.1)
236886002 (SNOMED CT 2011_0131-3)
10021151 (MedDRA 14.1-2)
76498008 (SNOMED CT 2011_0131-4)
14302001 (SNOMED CT 2011_0131-5)
10001928 (MedDRA 14.1-3)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
258707000 (SNOMED CT 2011_0131-6)
Y (HL7 V3 2006_05)
146680009 (SNOMED CT 2011_0131-7)
10010808 (MedDRA 14.1-4)
59261009 (SNOMED CT 2011_0131-8)
225370004 (SNOMED CT 2011_0131-9)
1305003 (SNOMED CT 2011_0131-10)
C0021361 (UMLS CUI-1)
C0700589 (UMLS CUI-2)
Contraceptive methods
Item
partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge) for 1 month prior to Visit 1 (screening visit) or longer if requested by the investigator. Women of childbearing potential must continue to practice birth control during the study and for at least 2 months after completing the study. Women of childbearing potential must have a negative pregnancy test at screening and Visit 2, 5, 7 and 9.
boolean
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
260676000 (SNOMED CT 2011_0131-2)
260676000 (SNOMED CT 2011_0131-3)
425484006 (SNOMED CT 2011_0131-4)
20359006 (SNOMED CT 2011_0131-5)
268460000 (SNOMED CT 2011_0131-6)
10022745 (MedDRA 14.1)
169529008 (SNOMED CT 2011_0131-7)
258706009 (SNOMED CT 2011_0131-8)
MO (HL7 V3 2006_05-2)
288556008 (SNOMED CT 2011_0131-9)
ENC (HL7 V3 2006_05-3)
242762006 (SNOMED CT 2011_0131-10)
385644000 (SNOMED CT 2011_0131-11)
224526002 (SNOMED CT 2011_0131-12)
146680009 (SNOMED CT 2011_0131-13)
10010808 (MedDRA 14.1-2)
371881003 (SNOMED CT 2011_0131-14)
110465008 (SNOMED CT 2011_0131-15)
19338005 (SNOMED CT 2011_0131-16)
258706009 (SNOMED CT 2011_0131-17)
MO (HL7 V3 2006_05-4)
237679004 (SNOMED CT 2011_0131-18)
250425007 (SNOMED CT 2011_0131-19)
10036574 (MedDRA 14.1-3)
ENC (HL7 V3 2006_05-5)
C0700589 (UMLS CUI-1)
Asthma severe
Item
Uncontrolled (refractory) asthma despite optimal treatment
boolean
19032002 (SNOMED CT 2011_0131)
20646008 (SNOMED CT 2011_0131-2)
195967001 (SNOMED CT 2011_0131-3)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
439401001 (SNOMED CT 2011_0131-4)
MTHU008876 (LOINC Version 232-2)
65897001 (SNOMED CT 2011_0131-5)
C0581126 (UMLS CUI-1)
uncontrolled asthma despite therapy
Item
subjects will have Global Initiative for Asthma (GINA 2006) clinical features of uncontrolled asthma despite treatment with a minimum dose of 800 g beclomethasone dipropionate or equivalent inhaled corticosteroid per day plus one or more additional controller i.e. long-acting b-agonist, leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as additional treatment at any dose are acceptable. The dose of inhaled and oral corticosteroids must have been stable within 4 weeks preceding Visit 1 (screening visit) and will be expected to remain stable for the duration of the study. If subjects are on single inhaler combination products at Visit 1 (e.g. fluticasone/salmeterol - Advair/Seretide or Symbicort (budesonide/formoterol) SMART) they must receive the two components as two separate inhaler medications for the purpose of the trial. This will facilitate withholding the long-acting b-agonist component before lung function and challenge testing (see Section 9.5.7). The GINA 2006 [14] levels of asthma control and treatment are described in Appendix 3.
boolean
C3862402 (UMLS CUI-1)
C0004906 (UMLS CUI-2)
C3248292 (UMLS CUI-3)
C0001644 (UMLS CUI-4)
C0039771 (UMLS CUI-5)
C0595726 (UMLS CUI-6)
C0205360 (UMLS CUI-7)
C0205195 (UMLS CUI-8)
FEV1 acceptable for AHR challenge test
Item
A forced expiratory volume in 1 second (FEV1) acceptable for AHR challenge tests (>= 60% of predicted normal) on the challenge days.
boolean
C0849974 (UMLS CUI-1)
C2733011 (UMLS CUI-2)
A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.
Item
A provocative concentration of methacholine causing a 20% fall in FEV1 (PC20) <= 4 mg/mL.
boolean
C1714622 (UMLS CUI 2015AA)
Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.
Item
Aged 18-80 years and are ambulatory and able to travel to the clinic.7. A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities.
boolean
C0001779 (UMLS CUI 2015AA)
C0439841 (UMLS CUI 2015AA-2)
C0522054 (UMLS CUI 2011AA)
Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.
Item
Clinical chemistry, haematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator.
boolean
C0438214 (UMLS CUI 2015AA)
Body weight of <= 130 kg.
Item
Body weight (observable entity)
boolean
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).
Item
No other clinically significant abnormality on history and clinical examination (see also Exclusion Criteria).
boolean
C2063084 (UMLS CUI 2015AA)
Able to comply with the requirements of the protocol.
Item
Able to comply with the requirements of the protocol.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA-2)
405078008 (SNOMED CT 2011_0131-2)
C1709747 (UMLS CUI 2011AA-3)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI 2011AA)
Experienced a severe exacerbation within 28 days preceding Visit 1.
Item
Experienced a severe exacerbation within 28 days preceding Visit 1.
boolean
C0038218 (UMLS CUI 2015AA)
C3828653 (UMLS CUI 2015AA-2)
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
Item
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study.
boolean
C0018621 (UMLS CUI 2015AA)
C1821205 (UMLS CUI 2015AA-2)
C3828653 (UMLS CUI 2015AA-3)
Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.
Item
Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given.
boolean
C2348568 (UMLS CUI 2015AA)
Lower respiratory tract infection within six weeks of Visit 1.5.
Item
Lower respiratory tract infection within six weeks of Visit 1.5.
boolean
C0149725 (UMLS CUI 2011AA)
50417007 (SNOMED CT 2011_0131)
10024968 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA-2)
258705008 (SNOMED CT 2011_0131-2)
WK (HL7 V3 2006_05)
C1512346 (UMLS CUI 2011AA-3)
ENC (HL7 V3 2006_05-2)
Current smokers or ex-smokers with more than 10 pack-years
Item
Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
boolean
77176002 (SNOMED CT 2011_0131)
10048880 (MedDRA 14.1)
8517006 (SNOMED CT 2011_0131-2)
10015572 (MedDRA 14.1-2)
315609007 (SNOMED CT 2011_0131-3)
260299005 (SNOMED CT 2011_0131-4)
MTHU024869 (LOINC Version 232)
258703001 (SNOMED CT 2011_0131-5)
D (HL7 V3 2006_05)
258707000 (SNOMED CT 2011_0131-6)
Y (HL7 V3 2006_05-2)
C0337664 (UMLS CUI-1)
C0337671 (UMLS CUI-2)
C1277691 (UMLS CUI-3)
Blood donation (> 550 mL) in the previous two months.
Item
Blood donation (> 550 mL) in the previous two months.
boolean
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA-2)
9130008 (SNOMED CT 2011_0131-2)
C0205448 (UMLS CUI 2011AA-3)
19338005 (SNOMED CT 2011_0131-3)
C0439231 (UMLS CUI 2011AA-4)
258706009 (SNOMED CT 2011_0131-4)
MO (HL7 V3 2006_05)
substance use
Item
Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse.
boolean
160592001 (SNOMED CT 2011_0131)
61254005 (SNOMED CT 2011_0131-2)
18669006 (SNOMED CT 2011_0131-3)
26416006 (SNOMED CT 2011_0131-4)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
61010005 (SNOMED CT 2011_0131-5)
417928002 (SNOMED CT 2011_0131-6)
10000341 (MedDRA 14.1-2)
C1705534 (UMLS CUI-1)
C0001948 (UMLS CUI-2)
other significant lung disease
Item
Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis.
boolean
C0024115 (UMLS CUI-1)
C0750502 (UMLS CUI-2)
prohibited medications
Item
Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications.
boolean
68405009 (SNOMED CT 2011_0131)
ENC (HL7 V3 2006_05)
MTHU024501 (LOINC Version 232)
C0013227 (UMLS CUI-1)
C3242263 (UMLS CUI-2)
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
Item
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension
boolean
C0184774 (UMLS CUI 2015AA)
hypertension heart disease psoriasis or stroke
Item
hypertension heart disease, psoriasis or stroke
boolean
C0020538 (UMLS CUI-1)
C0033860 (UMLS CUI-2)
C0038454 (UMLS CUI-3)
Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).
Item
Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements).
boolean
C3844688 (UMLS CUI 2015AA)
GP does not recommend participation
Item
The subject's primary care physician recommends the subject should not take part in the study.
boolean
446050000, 59058001 (SNOMED CT 2011_0131)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
116154003 (SNOMED CT 2011_0131-2)
PART (HL7 V3 2006_05-2)
110465008 (SNOMED CT 2011_0131-3)
C0017319 (UMLS CUI-1)
C3242266 (UMLS CUI-2)
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
Item
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs.
boolean
C0020517 (UMLS CUI 2015AA)
C0013227 (UMLS CUI 2015AA-2)
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