ID

14266

Description

Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02075255

Link

https://clinicaltrials.gov/show/NCT02075255

Keywords

Versions (1)
  1. 4/6/16 4/6/16 -
Uploaded on

April 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT02075255

English

Eligibility Asthma NCT02075255

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02075255
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent prior to any study specific procedures
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. female and male aged from 18 to 75 years, inclusively
Description

Age | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
3. history of physician-diagnosed asthma requiring treatment with medium dose ics and a laba
Description

Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C2065041
UMLS CUI [3]
C2936789
4. elevated level of peripheral blood eosinophil
Description

Eosinophilia | peripheral blood

Data type

boolean

Alias
UMLS CUI [1,1]
C0014457
UMLS CUI [1,2]
C0229664
5. documented treatment with high-dose ics and laba for at least 6 months prior to visit 1
Description

Therapeutic procedure | inhaled steroids | High dose | Adrenergic beta-2 Receptor Agonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2065041
UMLS CUI [1,3]
C0444956
UMLS CUI [2]
C2936789
6. chronic oral prednisone or prednisolone therapy for at least 6 continuous months directly preceding visit 1, and on a stable dose for at least one month prior to visit 1
Description

Therapeutic procedure | Prednisone Oral Product | prednisolone Oral Product

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3216040
UMLS CUI [2]
C0358513
7. patients with documented failures of ocs reduction within 6 months prior to visit 1 will not be required to proceed through the dose optimization phase during run-in.
Description

Adrenal Cortex Hormones | Reduced | failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0231175
8. morning pre-bronchodilator (pre-bd) fev1 of <80 percent predicted
Description

FEV1 | pre bronchodilator | Morning

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
UMLS CUI [1,3]
C0332170
9. either documented post bronchodilator (post-bd) reversibility of ≥ 12% and ≥ 200 ml in fev1 or pc20 fev1
Description

FEV1 | post bronchodilator | Reversibility

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
UMLS CUI [1,3]
C0449261
10. at least 1 documented asthma exacerbation in the previous 12 months prior to the date informed consent is obtained
Description

Exacerbation of asthma | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0021430
11. optimized ocs dose reached at least 2 weeks prior to randomization
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
12. additional asthma controller medication must not have been initiated during run-in period
Description

Asthma | Pharmaceutical Preparations | Additional

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1524062
13. at least 70 percent compliance with ocs use
Description

Compliance behavior | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0001617
14. at least 70 percent compliance with usual asthma controller ics-laba
Description

Compliance behavior | inhaled steroids | Adrenergic beta-2 Receptor Agonists

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C2065041
UMLS CUI [3]
C2936789
15. minimum 70 percent (i.e. 10 of 14 days) compliance with asthma daily diary (morning and evening diary)
Description

Compliance behavior | Asthma | Diaries

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0376660
16. no documented asthma exacerbations during the screening/dose optimization period
Description

Exacerbation of asthma

Data type

boolean

Alias
UMLS CUI [1]
C0349790
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.
Description

Lung diseases | Systemic disease | Eosinophilia

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0442893
UMLS CUI [3]
C0014457
2. any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
Description

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

Data type

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
Description

Disease | Affecting | patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
influence the findings of the studies or their interpretations
Description

Disease | Affecting | research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
impede the patient's ability to complete the entire duration of study
Description

Disease | Study Subject Participation Status | Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
3. 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
Description

Upper Respiratory Infections | Lower respiratory tract infection | Antibiotics | Antiviral Agents | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
UMLS CUI [3]
C0003232
UMLS CUI [4]
C0003451
UMLS CUI [5]
C0021430
4. any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in 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
Description

Abnormality | Physical Examination | Vital signs | Hematology finding | Chemistry, Clinical | Urinalysis | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0031809
UMLS CUI [2]
C0518766
UMLS CUI [3]
C0474523
UMLS CUI [4]
C0008000
UMLS CUI [5]
C0042014
UMLS CUI [6]
C2348568
5. history of life-threatening asthma
Description

Asthma | Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
6. asthma control reached at an ocs dose of ≤5mg during run-in/ocs optimization phase
Description

Asthma | control substance | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C1550141
UMLS CUI [3]
C0001617
7. qualifies for 3 consecutive dose reductions at visits 2-4 and continues to meet ocs dose reduction criteria at visit 5
Description

Drug dose | Reduced | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0392756
UMLS CUI [2]
C0001617
8. receipt of oral dexamethasone as the maintenance oral steroid controller for asthma symptoms
Description

Asthma | Symptoms | Oral form dexamethasone | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0360528
UMLS CUI [3]
C0001617
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Similar models

Eligibility Asthma NCT02075255

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02075255
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
1. provision of informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Age | Gender
Item
2. female and male aged from 18 to 75 years, inclusively
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists
Item
3. history of physician-diagnosed asthma requiring treatment with medium dose ics and a laba
boolean
C0004096 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
Eosinophilia | peripheral blood
Item
4. elevated level of peripheral blood eosinophil
boolean
C0014457 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Therapeutic procedure | inhaled steroids | High dose | Adrenergic beta-2 Receptor Agonists
Item
5. documented treatment with high-dose ics and laba for at least 6 months prior to visit 1
boolean
C0087111 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C0444956 (UMLS CUI [1,3])
C2936789 (UMLS CUI [2])
Therapeutic procedure | Prednisone Oral Product | prednisolone Oral Product
Item
6. chronic oral prednisone or prednisolone therapy for at least 6 continuous months directly preceding visit 1, and on a stable dose for at least one month prior to visit 1
boolean
C0087111 (UMLS CUI [1,1])
C3216040 (UMLS CUI [1,2])
C0358513 (UMLS CUI [2])
Adrenal Cortex Hormones | Reduced | failed
Item
7. patients with documented failures of ocs reduction within 6 months prior to visit 1 will not be required to proceed through the dose optimization phase during run-in.
boolean
C0001617 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
FEV1 | pre bronchodilator | Morning
Item
8. morning pre-bronchodilator (pre-bd) fev1 of <80 percent predicted
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
FEV1 | post bronchodilator | Reversibility
Item
9. either documented post bronchodilator (post-bd) reversibility of ≥ 12% and ≥ 200 ml in fev1 or pc20 fev1
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
C0449261 (UMLS CUI [1,3])
Exacerbation of asthma | Informed Consent
Item
10. at least 1 documented asthma exacerbation in the previous 12 months prior to the date informed consent is obtained
boolean
C0349790 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Adrenal Cortex Hormones
Item
11. optimized ocs dose reached at least 2 weeks prior to randomization
boolean
C0001617 (UMLS CUI [1])
Asthma | Pharmaceutical Preparations | Additional
Item
12. additional asthma controller medication must not have been initiated during run-in period
boolean
C0004096 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Compliance behavior | Adrenal Cortex Hormones
Item
13. at least 70 percent compliance with ocs use
boolean
C1321605 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
Compliance behavior | inhaled steroids | Adrenergic beta-2 Receptor Agonists
Item
14. at least 70 percent compliance with usual asthma controller ics-laba
boolean
C1321605 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
Compliance behavior | Asthma | Diaries
Item
15. minimum 70 percent (i.e. 10 of 14 days) compliance with asthma daily diary (morning and evening diary)
boolean
C1321605 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C0376660 (UMLS CUI [2,2])
Exacerbation of asthma
Item
16. no documented asthma exacerbations during the screening/dose optimization period
boolean
C0349790 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lung diseases | Systemic disease | Eosinophilia
Item
1. clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.
boolean
C0024115 (UMLS CUI [1])
C0442893 (UMLS CUI [2])
C0014457 (UMLS CUI [3])
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
2. any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, 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])
Disease | Affecting | patient safety
Item
affect the safety of the patient throughout the study
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
Disease | Affecting | research results
Item
influence the findings of the studies or their interpretations
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Disease | Study Subject Participation Status | Limited
Item
impede the patient's ability to complete the entire duration of study
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Upper Respiratory Infections | Lower respiratory tract infection | Antibiotics | Antiviral Agents | Informed Consent
Item
3. 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
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
C0003232 (UMLS CUI [3])
C0003451 (UMLS CUI [4])
C0021430 (UMLS CUI [5])
Abnormality | Physical Examination | Vital signs | Hematology finding | Chemistry, Clinical | Urinalysis | Study Subject Participation Status
Item
4. any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in 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
C1704258 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
C0474523 (UMLS CUI [3])
C0008000 (UMLS CUI [4])
C0042014 (UMLS CUI [5])
C2348568 (UMLS CUI [6])
Asthma | Life Threatening
Item
5. history of life-threatening asthma
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Asthma | control substance | Adrenal Cortex Hormones
Item
6. asthma control reached at an ocs dose of ≤5mg during run-in/ocs optimization phase
boolean
C0004096 (UMLS CUI [1])
C1550141 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
Drug dose | Reduced | Adrenal Cortex Hormones
Item
7. qualifies for 3 consecutive dose reductions at visits 2-4 and continues to meet ocs dose reduction criteria at visit 5
boolean
C0678766 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2])
Asthma | Symptoms | Oral form dexamethasone | Adrenal Cortex Hormones
Item
8. receipt of oral dexamethasone as the maintenance oral steroid controller for asthma symptoms
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0360528 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
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