ID

14279

Beschreibung

CYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids; ODM derived from: https://clinicaltrials.gov/show/NCT02087644

Link

https://clinicaltrials.gov/show/NCT02087644

Stichworte

Versionen (1)
  1. 07.04.16 07.04.16 -
Hochgeladen am

7. April 2016

DOI

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Eligibility Asthma NCT02087644

Englisch

Eligibility Asthma NCT02087644

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02087644
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provide written informed consent.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. complete all protocol requirements.
Beschreibung

Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
3. between 18 to 65 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. persistent allergic asthma patients
Beschreibung

Persistent allergic asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155877
UMLS CUI [1,2]
C0205322
5. forced expiratory volume in one second (fev1) ≥60 percent to ≤ 90 percent of predicted value
Beschreibung

FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
6. reversibility of airway obstruction
Beschreibung

Airway Obstruction Reversibility

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001883
UMLS CUI [1,2]
C0449261
7. patients meeting the contraception requirements
Beschreibung

Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
8. at baseline: patients treated with ics and insufficiently controlled
Beschreibung

Therapeutic procedure Inhaled steroids | Poorly controlled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2065041
UMLS CUI [2]
C3853134
9. blood eosinophil count above a certain level
Beschreibung

Eosinophil count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0200638
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. failure to meet at least 80 percent compliance of use of the patient e-diary/ peak expiratory flow (pef) meter (am3 device) at the baseline visit
Beschreibung

Compliance behavior Personal failure Diaries | Compliance behavior Personal failure Peak flow meter (device)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0680095
UMLS CUI [1,3]
C0376660
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0680095
UMLS CUI [2,3]
C0180915
2. treatment or hospitalization for asthma exacerbation within past 2 months
Beschreibung

Therapeutic procedure Exacerbation of asthma | Hospitalization Exacerbation of asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0349790
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0349790
3. current use or use of systemic corticosteroids within past 2 months
Beschreibung

systemic steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C2825233
4. current smokers.
Beschreibung

Current Smoker

Datentyp

boolean

Alias
UMLS CUI [1]
C3241966
5. ex-smokers for less than 1 year, with a tobacco smoking history of >10 pack years
Beschreibung

Former smoker Smoking cigarettes: ____ pack-years history

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C2230126
6. major surgery within 3 months prior to signing the icf or anticipated during study
Beschreibung

major surgery | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0021430
7. presence or history of clinically relevant cardiovascular, renal, pulmonary (e.g. copd), endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.
Beschreibung

Cardiovascular Diseases | Kidney Diseases | Lung diseases | Chronic Obstructive Airway Disease | Endocrine System Diseases | Autoimmune Diseases | Dermatologic disorders | nervous system disorder | Mental disorders | Disorder of eye

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0024117
UMLS CUI [5]
C0014130
UMLS CUI [6]
C0004364
UMLS CUI [7]
C0037274
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0004936
UMLS CUI [10]
C0015397
8. any malignancy within the previous 5 years
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
9. presence of suspicious lymphadenopathy or splenomegaly on physical examination.
Beschreibung

Lymphadenopathy | Splenomegaly | Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0497156
UMLS CUI [2]
C0038002
UMLS CUI [3]
C0031809
10. confirmed or suspected current infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv).
Beschreibung

Communicable Diseases HIV | Communicable Diseases Hepatitis B Virus | Communicable Diseases Hepatitis C virus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0019682
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0019169
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0220847
11. presence of active infectious disease as judged by the investigator
Beschreibung

Communicable Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
12. active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.
Beschreibung

Autoimmune Diseases | Rheumatoid Arthritis | lupus erythematodes | Ulcerative Colitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0866588
UMLS CUI [4]
C0009324
13. pregnancy (based on positive urine test at screening visit) or lactation.
Beschreibung

Pregnancy Urine pregnancy test positive | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430059
UMLS CUI [2]
C0006147
14. female planning to become pregnant during the study period.
Beschreibung

Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032992
15. patients with any history of abuse of alcohol or other recreational drugs.
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
16. ongoing or planned specific immunotherapy (sit) during the whole study period or sit completed within the last 3 years.
Beschreibung

Immunotherapy, specific

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0205369
17. bmi >40
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
18. use of investigational or approved biologics/immune-modulators within the last 6 months.
Beschreibung

Biological Factors | Biological Response Modifiers

Datentyp

boolean

Alias
UMLS CUI [1]
C0005515
UMLS CUI [2]
C0005525
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Ähnliche Modelle

Eligibility Asthma NCT02087644

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02087644
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
1. provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Compliance behavior
Item
2. complete all protocol requirements.
boolean
C1321605 (UMLS CUI [1])
Age
Item
3. between 18 to 65 years of age.
boolean
C0001779 (UMLS CUI [1])
Persistent allergic asthma
Item
4. persistent allergic asthma patients
boolean
C0155877 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
FEV1
Item
5. forced expiratory volume in one second (fev1) ≥60 percent to ≤ 90 percent of predicted value
boolean
C0748133 (UMLS CUI [1])
Airway Obstruction Reversibility
Item
6. reversibility of airway obstruction
boolean
C0001883 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
Contraceptive methods
Item
7. patients meeting the contraception requirements
boolean
C0700589 (UMLS CUI [1])
Therapeutic procedure Inhaled steroids | Poorly controlled
Item
8. at baseline: patients treated with ics and insufficiently controlled
boolean
C0087111 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C3853134 (UMLS CUI [2])
Eosinophil count procedure
Item
9. blood eosinophil count above a certain level
boolean
C0200638 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Compliance behavior Personal failure Diaries | Compliance behavior Personal failure Peak flow meter (device)
Item
1. failure to meet at least 80 percent compliance of use of the patient e-diary/ peak expiratory flow (pef) meter (am3 device) at the baseline visit
boolean
C1321605 (UMLS CUI [1,1])
C0680095 (UMLS CUI [1,2])
C0376660 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0680095 (UMLS CUI [2,2])
C0180915 (UMLS CUI [2,3])
Therapeutic procedure Exacerbation of asthma | Hospitalization Exacerbation of asthma
Item
2. treatment or hospitalization for asthma exacerbation within past 2 months
boolean
C0087111 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0349790 (UMLS CUI [2,2])
systemic steroids
Item
3. current use or use of systemic corticosteroids within past 2 months
boolean
C2825233 (UMLS CUI [1])
Current Smoker
Item
4. current smokers.
boolean
C3241966 (UMLS CUI [1])
Former smoker Smoking cigarettes: ____ pack-years history
Item
5. ex-smokers for less than 1 year, with a tobacco smoking history of >10 pack years
boolean
C0337671 (UMLS CUI [1,1])
C2230126 (UMLS CUI [1,2])
major surgery | Informed Consent
Item
6. major surgery within 3 months prior to signing the icf or anticipated during study
boolean
C0679637 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Cardiovascular Diseases | Kidney Diseases | Lung diseases | Chronic Obstructive Airway Disease | Endocrine System Diseases | Autoimmune Diseases | Dermatologic disorders | nervous system disorder | Mental disorders | Disorder of eye
Item
7. presence or history of clinically relevant cardiovascular, renal, pulmonary (e.g. copd), endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.
boolean
C0007222 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0004364 (UMLS CUI [6])
C0037274 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0004936 (UMLS CUI [9])
C0015397 (UMLS CUI [10])
Malignant Neoplasms
Item
8. any malignancy within the previous 5 years
boolean
C0006826 (UMLS CUI [1])
Lymphadenopathy | Splenomegaly | Physical Examination
Item
9. presence of suspicious lymphadenopathy or splenomegaly on physical examination.
boolean
C0497156 (UMLS CUI [1])
C0038002 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Communicable Diseases HIV | Communicable Diseases Hepatitis B Virus | Communicable Diseases Hepatitis C virus
Item
10. confirmed or suspected current infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv).
boolean
C0009450 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
Communicable Diseases
Item
11. presence of active infectious disease as judged by the investigator
boolean
C0009450 (UMLS CUI [1])
Autoimmune Diseases | Rheumatoid Arthritis | lupus erythematodes | Ulcerative Colitis
Item
12. active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.
boolean
C0004364 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0866588 (UMLS CUI [3])
C0009324 (UMLS CUI [4])
Pregnancy Urine pregnancy test positive | Breast Feeding
Item
13. pregnancy (based on positive urine test at screening visit) or lactation.
boolean
C0032961 (UMLS CUI [1,1])
C0430059 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
Pregnancy, Planned
Item
14. female planning to become pregnant during the study period.
boolean
C0032992 (UMLS CUI [1])
Substance Use Disorders
Item
15. patients with any history of abuse of alcohol or other recreational drugs.
boolean
C0038586 (UMLS CUI [1])
Immunotherapy, specific
Item
16. ongoing or planned specific immunotherapy (sit) during the whole study period or sit completed within the last 3 years.
boolean
C0021083 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Body mass index
Item
17. bmi >40
boolean
C1305855 (UMLS CUI [1])
Biological Factors | Biological Response Modifiers
Item
18. use of investigational or approved biologics/immune-modulators within the last 6 months.
boolean
C0005515 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
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