ID

14134

Descripción

Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01928771

Link

https://clinicaltrials.gov/show/NCT01928771

Palabras clave

Versiones (1)
  1. 31/3/16 31/3/16 -
Subido en

31 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Asthma NCT01928771

Inglés

Eligibility Asthma NCT01928771

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01928771
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable european union guidelines.
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
2. female and male aged 12 to 75 years inclusively, at the time of visit 1. for those patients, who are 17 on the day of visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
Descripción

Age | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0205653
UMLS CUI [2]
C0079399
3. history of physician-diagnosed asthma requiring treatment with medium-to-high dose ics (>250μg fluticasone dry powder formulation equivalents total daily dose) and a laba, for at least 12 months prior to visit 1
Descripción

Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C2065041
UMLS CUI [3]
C0082607
UMLS CUI [4]
C2936789
4. documented treatment with ics and laba for at least 3 months prior to visit 1 with or without oral corticosteroids and additional asthma controllers.
Descripción

Therapeutic procedure | inhaled steroids | Adrenergic beta-2 Receptor Agonists | Oral steroids

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2065041
UMLS CUI [2]
C2936789
UMLS CUI [3]
C0001617
for subjects 18 years of age and older, the ics dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
Descripción

Age | inhaled steroids | Fluticasone propionate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2065041
UMLS CUI [3]
C0117996
for subjects ages 12-17, the ics dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.
Descripción

Age | inhaled steroids | Fluticasone propionate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C2065041
UMLS CUI [3]
C0117996
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinically important pulmonary disease other than asthma (e.g. 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 (e.g. allergic bronchopulmonary aspergillosis/mycosis, churg- strauss syndrome, hypereosinophilic syndrome)
Descripción

Pulmonary disease | Systemic disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024115
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]
C0221757
UMLS CUI [11]
C0008780
UMLS CUI [12]
C0442893
UMLS CUI [13]
C2350530
UMLS CUI [14]
C2931854
UMLS CUI [15]
C0008728
UMLS CUI [16]
C1540912
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:
Descripción

Disease | Stable status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0026857
UMLS CUI [8]
C0009450
UMLS CUI [9]
C0014130
UMLS CUI [10]
C0025517
UMLS CUI [11]
C0018939
UMLS CUI [12]
C0004936
UMLS CUI [13]
C0231171
affect the safety of the patient throughout the study
Descripción

Comorbidity | patient safety

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
influence the findings of the studies or their interpretations
Descripción

Compliance behavior | Limited | Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
impede the patient's ability to complete the entire duration of study
Descripción

Comorbidity | Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C2348568
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
Descripción

Upper Respiratory Infections | Lower respiratory tract infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
UMLS CUI [3]
C0003232
UMLS CUI [4]
C0003451
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
Descripción

Abnormal Finding | Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826279
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
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Similar models

Eligibility Asthma NCT01928771

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01928771
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
1. written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable european union guidelines.
boolean
C0021430 (UMLS CUI [1])
Age | Gender
Item
2. female and male aged 12 to 75 years inclusively, at the time of visit 1. for those patients, who are 17 on the day of visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
boolean
C0001779 (UMLS CUI [1,1])
C0205653 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists
Item
3. history of physician-diagnosed asthma requiring treatment with medium-to-high dose ics (>250μg fluticasone dry powder formulation equivalents total daily dose) and a laba, for at least 12 months prior to visit 1
boolean
C0004096 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C0082607 (UMLS CUI [3])
C2936789 (UMLS CUI [4])
Therapeutic procedure | inhaled steroids | Adrenergic beta-2 Receptor Agonists | Oral steroids
Item
4. documented treatment with ics and laba for at least 3 months prior to visit 1 with or without oral corticosteroids and additional asthma controllers.
boolean
C0087111 (UMLS CUI [1,1])
C2065041 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
Age | inhaled steroids | Fluticasone propionate
Item
for subjects 18 years of age and older, the ics dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
boolean
C0001779 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3])
Age | inhaled steroids | Fluticasone propionate
Item
for subjects ages 12-17, the ics dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.
boolean
C0001779 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Pulmonary disease | Systemic disease
Item
1. clinically important pulmonary disease other than asthma (e.g. 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 (e.g. allergic bronchopulmonary aspergillosis/mycosis, churg- strauss syndrome, hypereosinophilic syndrome)
boolean
C0024115 (UMLS CUI [1])
C0876973 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
C0006267 (UMLS CUI [4])
C0034069 (UMLS CUI [5])
C0010674 (UMLS CUI [6])
C0745186 (UMLS CUI [7])
C0028754 (UMLS CUI [8])
C0242379 (UMLS CUI [9])
C0221757 (UMLS CUI [10])
C0008780 (UMLS CUI [11])
C0442893 (UMLS CUI [12])
C2350530 (UMLS CUI [13])
C2931854 (UMLS CUI [14])
C0008728 (UMLS CUI [15])
C1540912 (UMLS CUI [16])
Disease | Stable status
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
C0012634 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
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 (UMLS CUI [13])
Comorbidity | 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
influence the findings of the studies or their interpretations
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Comorbidity | Study Subject Participation Status
Item
impede the patient's ability to complete the entire duration of study
boolean
C0009488 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Upper Respiratory Infections | Lower respiratory tract infection
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])
Abnormal Finding | 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
C2826279 (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])
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