ID

14408

Beschrijving

Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02322775

Link

https://clinicaltrials.gov/show/NCT02322775

Trefwoorden

Versies (1)
  1. 13-04-16 13-04-16 -
Geüploaded op

13 april 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Asthma NCT02322775

Engels

Eligibility Asthma NCT02322775

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02322775
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable european union (eu) guidelines.
Beschrijving

Informed Consent | International Guidelines | European Union Guidelines

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1512888
UMLS CUI [2,2]
C0162791
UMLS CUI [3,1]
C0015179
UMLS CUI [3,2]
C0162791
female and male aged 18 to 75 years, inclusively, at the time of visit 1.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
weight of ≥40 kg.
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
evidence of asthma as documented by post-bronchodilator (post-bd) reversibility in fev1 of ≥ 12% demonstrated at visit 2.
Beschrijving

Asthma | Forced Expiratory Volume in 1 Second Reversibility post bronchodilator

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C3830088
UMLS CUI [2,2]
C2599594
documented use of 1 of the following types of asthma therapy at time of informed consent: low- to medium-dose ics (ie, 100 to 500 μg fluticasone dry powder formulation equivalents total daily dose) with or without other controller medications, eg, an ltra and/or theophylline or low-dose ics/laba fixed combination therapy (eg, the lowest regular maintenance dose approved in the local country will meet this criterion)
Beschrijving

Therapeutic procedure Asthma | Informed Consent | inhaled steroids | fluticasone Dry Powder Inhaler | Leukotriene Antagonists | Theophylline | inhaled steroids | Adrenergic beta-2 Receptor Agonists

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C0021430
UMLS CUI [3]
C2065041
UMLS CUI [4]
C1967989
UMLS CUI [5]
C0595726
UMLS CUI [6]
C0039771
UMLS CUI [7]
C2065041
UMLS CUI [8]
C2936789
morning pre-bronchodilator (pre-bd) fev1 of > 50% to ≤ 90% predicted at visit 2.
Beschrijving

FEV1 pre bronchodilator Morning

Datatype

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
UMLS CUI [1,3]
C0332170
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically important pulmonary disease other than asthma (eg, active lung infection, copd, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, churg-strauss syndrome, hypereosinophilic syndrome).
Beschrijving

Lung diseases | Asthma | Infectious disease of lung | Chronic Obstructive Airway Disease | Bronchiectasis | Pulmonary Fibrosis | Cystic Fibrosis | hypoventilation syndrome | Obesity | Malignant neoplasm of lung | alpha 1-Antitrypsin Deficiency | Ciliary Motility Disorders | Systemic disease | Eosinophil count raised (finding) | Aspergillosis, Allergic Bronchopulmonary | Allergic Bronchopulmonary Mycosis | Churg-Strauss Syndrome | Hypereosinophilic syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0876973
UMLS CUI [4]
C0024117
UMLS CUI [5]
C0006267
UMLS CUI [6]
C0034069
UMLS CUI [7]
C0010674
UMLS CUI [8]
C0745186
UMLS CUI [9]
C0028754
UMLS CUI [10]
C0242379
UMLS CUI [11,1]
C0002191
UMLS CUI [11,2]
C0011155
UMLS CUI [12]
C0008780
UMLS CUI [13]
C0442893
UMLS CUI [14]
C2240374
UMLS CUI [15]
C0004031
UMLS CUI [16]
C2931854
UMLS CUI [17]
C0008728
UMLS CUI [18]
C1540912
any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
Beschrijving

Cardiovascular Diseases | Gastrointestinal Diseases | Liver diseases | Kidney Diseases | nervous system disorder | Musculoskeletal Diseases | Communicable Diseases | Endocrine System Diseases | Metabolic Diseases | Hematological Disease | Mental disorders | Physical impairment

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0026857
UMLS CUI [7]
C0009450
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0025517
UMLS CUI [10]
C0018939
UMLS CUI [11]
C0004936
UMLS CUI [12]
C0231171
affect the safety of the patient throughout the study
Beschrijving

Comorbidity Affecting patient safety

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
nfluence the findings of the studies or their interpretations,- impede the patient's ability to complete the entire duration of study.
Beschrijving

Compliance behavior Limited Comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
known history of allergy or reaction to the investigational product formulation.
Beschrijving

Hypersensitivity Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
history of anaphylaxis to any biologic therapy.- history of guillain-barré syndrome.
Beschrijving

anaphylaxis Biological Response Modifier Therapy | Guillain-Barre Syndrome

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0005527
UMLS CUI [2]
C0018378
a helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.- acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
Beschrijving

Helminthiasis | Informed Consent | Therapeutic procedure failed | Upper Respiratory Infections | Lower respiratory tract infection | Antibiotics | Antiviral Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0018889
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0231175
UMLS CUI [4]
C0041912
UMLS CUI [5]
C0149725
UMLS CUI [6]
C0003232
UMLS CUI [7]
C0003451
any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study.
Beschrijving

Abnormal Finding | Physical Examination | Vital signs | Hematology finding | Chemistry, Clinical | Urinalysis | Study Subject Participation Status Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1]
C2826279
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0518766
UMLS CUI [4]
C0474523
UMLS CUI [5]
C0008000
UMLS CUI [6]
C0042014
UMLS CUI [7,1]
C2348568
UMLS CUI [7,2]
C1321605
UMLS CUI [7,3]
C0439801
positive hepatitis b surface antigen, or hepatitis c virus antibody serology, or a positive medical history for hepatitis b or c. patients with a history of hepatitis b vaccination without history of hepatitis b are allowed to enroll.
Beschrijving

Hepatitis B surface antigen positive | Hepatitis C Antibodies Serologic tests | Hepatitis B positive | Hepatitis C positive | History of hepatitis B vaccination | History of hepatitis B

Datatype

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0036743
UMLS CUI [3]
C0856706
UMLS CUI [4]
C1112419
UMLS CUI [5]
C1960633
UMLS CUI [6]
C1997078
a history of known immunodeficiency disorder including a positive human immunodeficiency virus (hiv) test.
Beschrijving

Immunologic Deficiency Syndromes | HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0019699
history of cancer:
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
Beschrijving

Basal cell carcinoma | Squamous cell carcinoma | Carcinoma in situ of uterine cervix | Cancer Remission | curative treatment | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0007117
UMLS CUI [2]
C0007137
UMLS CUI [3]
C0851140
UMLS CUI [4]
C0687702
UMLS CUI [5]
C1273390
UMLS CUI [6]
C0021430
patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained
Beschrijving

Malignant Neoplasms | Patient eligible for clinical trial | Cancer Remission | curative treatment | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1302261
UMLS CUI [3]
C0687702
UMLS CUI [4]
C1273390
UMLS CUI [5]
C0021430
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Similar models

Eligibility Asthma NCT02322775

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02322775
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | International Guidelines | European Union Guidelines
Item
written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable european union (eu) guidelines.
boolean
C0021430 (UMLS CUI [1])
C1512888 (UMLS CUI [2,1])
C0162791 (UMLS CUI [2,2])
C0015179 (UMLS CUI [3,1])
C0162791 (UMLS CUI [3,2])
Age
Item
female and male aged 18 to 75 years, inclusively, at the time of visit 1.
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
weight of ≥40 kg.
boolean
C0005910 (UMLS CUI [1])
Asthma | Forced Expiratory Volume in 1 Second Reversibility post bronchodilator
Item
evidence of asthma as documented by post-bronchodilator (post-bd) reversibility in fev1 of ≥ 12% demonstrated at visit 2.
boolean
C0004096 (UMLS CUI [1])
C3830088 (UMLS CUI [2,1])
C2599594 (UMLS CUI [2,2])
Therapeutic procedure Asthma | Informed Consent | inhaled steroids | fluticasone Dry Powder Inhaler | Leukotriene Antagonists | Theophylline | inhaled steroids | Adrenergic beta-2 Receptor Agonists
Item
documented use of 1 of the following types of asthma therapy at time of informed consent: low- to medium-dose ics (ie, 100 to 500 μg fluticasone dry powder formulation equivalents total daily dose) with or without other controller medications, eg, an ltra and/or theophylline or low-dose ics/laba fixed combination therapy (eg, the lowest regular maintenance dose approved in the local country will meet this criterion)
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C1967989 (UMLS CUI [4])
C0595726 (UMLS CUI [5])
C0039771 (UMLS CUI [6])
C2065041 (UMLS CUI [7])
C2936789 (UMLS CUI [8])
FEV1 pre bronchodilator Morning
Item
morning pre-bronchodilator (pre-bd) fev1 of > 50% to ≤ 90% predicted at visit 2.
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Lung diseases | Asthma | Infectious disease of lung | Chronic Obstructive Airway Disease | Bronchiectasis | Pulmonary Fibrosis | Cystic Fibrosis | hypoventilation syndrome | Obesity | Malignant neoplasm of lung | alpha 1-Antitrypsin Deficiency | Ciliary Motility Disorders | Systemic disease | Eosinophil count raised (finding) | Aspergillosis, Allergic Bronchopulmonary | Allergic Bronchopulmonary Mycosis | Churg-Strauss Syndrome | Hypereosinophilic syndrome
Item
clinically important pulmonary disease other than asthma (eg, active lung infection, copd, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, churg-strauss syndrome, hypereosinophilic syndrome).
boolean
C0024115 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0876973 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0006267 (UMLS CUI [5])
C0034069 (UMLS CUI [6])
C0010674 (UMLS CUI [7])
C0745186 (UMLS CUI [8])
C0028754 (UMLS CUI [9])
C0242379 (UMLS CUI [10])
C0002191 (UMLS CUI [11,1])
C0011155 (UMLS CUI [11,2])
C0008780 (UMLS CUI [12])
C0442893 (UMLS CUI [13])
C2240374 (UMLS CUI [14])
C0004031 (UMLS CUI [15])
C2931854 (UMLS CUI [16])
C0008728 (UMLS CUI [17])
C1540912 (UMLS CUI [18])
Cardiovascular Diseases | Gastrointestinal Diseases | Liver diseases | Kidney Diseases | nervous system disorder | Musculoskeletal Diseases | Communicable Diseases | Endocrine System Diseases | Metabolic Diseases | Hematological Disease | Mental disorders | Physical impairment
Item
any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
boolean
C0007222 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0026857 (UMLS CUI [6])
C0009450 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0231171 (UMLS CUI [12])
Comorbidity Affecting patient safety
Item
affect the safety of the patient throughout the study
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
Compliance behavior Limited Comorbidity
Item
nfluence the findings of the studies or their interpretations,- impede the patient's ability to complete the entire duration of study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs
Item
known history of allergy or reaction to the investigational product formulation.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
anaphylaxis Biological Response Modifier Therapy | Guillain-Barre Syndrome
Item
history of anaphylaxis to any biologic therapy.- history of guillain-barré syndrome.
boolean
C0002792 (UMLS CUI [1,1])
C0005527 (UMLS CUI [1,2])
C0018378 (UMLS CUI [2])
Helminthiasis | Informed Consent | Therapeutic procedure failed | Upper Respiratory Infections | Lower respiratory tract infection | Antibiotics | Antiviral Agents
Item
a helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.- acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
boolean
C0018889 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0041912 (UMLS CUI [4])
C0149725 (UMLS CUI [5])
C0003232 (UMLS CUI [6])
C0003451 (UMLS CUI [7])
Abnormal Finding | Physical Examination | Vital signs | Hematology finding | Chemistry, Clinical | Urinalysis | Study Subject Participation Status Compliance behavior Limited
Item
any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study.
boolean
C2826279 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C0518766 (UMLS CUI [3])
C0474523 (UMLS CUI [4])
C0008000 (UMLS CUI [5])
C0042014 (UMLS CUI [6])
C2348568 (UMLS CUI [7,1])
C1321605 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Hepatitis B surface antigen positive | Hepatitis C Antibodies Serologic tests | Hepatitis B positive | Hepatitis C positive | History of hepatitis B vaccination | History of hepatitis B
Item
positive hepatitis b surface antigen, or hepatitis c virus antibody serology, or a positive medical history for hepatitis b or c. patients with a history of hepatitis b vaccination without history of hepatitis b are allowed to enroll.
boolean
C0149709 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C0856706 (UMLS CUI [3])
C1112419 (UMLS CUI [4])
C1960633 (UMLS CUI [5])
C1997078 (UMLS CUI [6])
Immunologic Deficiency Syndromes | HIV Seropositivity
Item
a history of known immunodeficiency disorder including a positive human immunodeficiency virus (hiv) test.
boolean
C0021051 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Malignant Neoplasms
Item
history of cancer:
boolean
C0006826 (UMLS CUI [1])
Basal cell carcinoma | Squamous cell carcinoma | Carcinoma in situ of uterine cervix | Cancer Remission | curative treatment | Informed Consent
Item
patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
boolean
C0007117 (UMLS CUI [1])
C0007137 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C0687702 (UMLS CUI [4])
C1273390 (UMLS CUI [5])
C0021430 (UMLS CUI [6])
Malignant Neoplasms | Patient eligible for clinical trial | Cancer Remission | curative treatment | Informed Consent
Item
patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained
boolean
C0006826 (UMLS CUI [1])
C1302261 (UMLS CUI [2])
C0687702 (UMLS CUI [3])
C1273390 (UMLS CUI [4])
C0021430 (UMLS CUI [5])
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