ID

14438

Descrição

Efficacy and Safety of BI 655066 in Patients With Severe Persistent Asthma.; ODM derived from: https://clinicaltrials.gov/show/NCT02443298

Link

https://clinicaltrials.gov/show/NCT02443298

Palavras-chave

Versões (1)
  1. 15/04/2016 15/04/2016 -
Transferido a

15 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Asthma NCT02443298

Inglês

Eligibility Asthma NCT02443298

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02443298
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pre-bronchodilator clinic measured fev1 of =40% and =85% of predicted normal.
Descrição

pre bronchodilator FEV1

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2599602
UMLS CUI [1,2]
C0748133
2. one year history of asthma diagnosed by a physician, and have fev1 reversibility of = 12% and an absolute change of at least 200 ml after administration of 400 µg salbutamol.
Descrição

Asthma | Forced Expiratory Volume in 1 Second Reversibility | Albuterol

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C3830088
UMLS CUI [3]
C0001927
3. must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
Descrição

inhaled steroids | Asthma control Pharmaceutical Preparations

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0243148
UMLS CUI [2,3]
C0013227
4. must have documented history of two or more severe asthma exacerbations in the last 12 months.
Descrição

Exacerbation of severe persistent asthma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3508930
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a significant disease other than asthma.
Descrição

Disease | Asthma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0004096
2. patients who are not able to produce sputum or sputum samples of sufficient quality.
Descrição

Ability Sputum production Quality | Ability Sputum specimen Quality

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0242104
UMLS CUI [1,3]
C0332306
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0444159
UMLS CUI [2,3]
C0332306
3. patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
Descrição

Exacerbation of asthma Intubation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0021925
4. patients diagnosed with any concurrent respiratory disease.
Descrição

Respiration Disorders Concurrent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0205420
5. recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
Descrição

Myocardial Infarction | Hospitalization Heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0018801
6. patients who have undergone thoracotomy with pulmonary resection.
Descrição

Thoracotomy Lung excision

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0039991
UMLS CUI [1,2]
C0396565
7. patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
Descrição

Bronchial thermoplasty | Therapeutic radiology procedure | Planned procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3854686
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1320712
8. patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
Descrição

Adrenal Cortex Hormones | Prednisone

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0032952
9. pregnant or nursing women.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
Descrição

Childbearing Potential | Sexually active | Unwilling Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0241028
UMLS CUI [3,1]
C0558080
UMLS CUI [3,2]
C0700589
11. clinically relevant acute infections or chronic infections.
Descrição

Acute infectious disease | Chronic infectious disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0275518
UMLS CUI [2]
C0151317
12. have received any live bacterial or live viral vaccination in the last12 weeks.
Descrição

Attenuated Bacteria Vaccine | Attenuated Live Virus Vaccine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1879753
UMLS CUI [2]
C1516086
13. have received bacille calmette-guerin (bcg) vaccination in the last 12 months.
Descrição

BCG Vaccine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004886
14. have received treatment with ustekinumab (stelara®).
Descrição

Therapeutic procedure Ustekinumab Stelara

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1608841
UMLS CUI [1,3]
C2702169
15. have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.
Descrição

Other Biological Products

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0005522
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Similar models

Eligibility Asthma NCT02443298

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02443298
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
pre bronchodilator FEV1
Item
1. pre-bronchodilator clinic measured fev1 of =40% and =85% of predicted normal.
boolean
C2599602 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
Asthma | Forced Expiratory Volume in 1 Second Reversibility | Albuterol
Item
2. one year history of asthma diagnosed by a physician, and have fev1 reversibility of = 12% and an absolute change of at least 200 ml after administration of 400 µg salbutamol.
boolean
C0004096 (UMLS CUI [1])
C3830088 (UMLS CUI [2])
C0001927 (UMLS CUI [3])
inhaled steroids | Asthma control Pharmaceutical Preparations
Item
3. must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
boolean
C2065041 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Exacerbation of severe persistent asthma
Item
4. must have documented history of two or more severe asthma exacerbations in the last 12 months.
boolean
C3508930 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease | Asthma
Item
1. patients with a significant disease other than asthma.
boolean
C0012634 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
Ability Sputum production Quality | Ability Sputum specimen Quality
Item
2. patients who are not able to produce sputum or sputum samples of sufficient quality.
boolean
C0085732 (UMLS CUI [1,1])
C0242104 (UMLS CUI [1,2])
C0332306 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C0444159 (UMLS CUI [2,2])
C0332306 (UMLS CUI [2,3])
Exacerbation of asthma Intubation
Item
3. patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
boolean
C0349790 (UMLS CUI [1,1])
C0021925 (UMLS CUI [1,2])
Respiration Disorders Concurrent
Item
4. patients diagnosed with any concurrent respiratory disease.
boolean
C0035204 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Myocardial Infarction | Hospitalization Heart failure
Item
5. recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
boolean
C0027051 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Thoracotomy Lung excision
Item
6. patients who have undergone thoracotomy with pulmonary resection.
boolean
C0039991 (UMLS CUI [1,1])
C0396565 (UMLS CUI [1,2])
Bronchial thermoplasty | Therapeutic radiology procedure | Planned procedure
Item
7. patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
boolean
C3854686 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1320712 (UMLS CUI [3])
Adrenal Cortex Hormones | Prednisone
Item
8. patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
9. pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential | Sexually active | Unwilling Contraceptive methods
Item
10. women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
boolean
C3831118 (UMLS CUI [1])
C0241028 (UMLS CUI [2])
C0558080 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Acute infectious disease | Chronic infectious disease
Item
11. clinically relevant acute infections or chronic infections.
boolean
C0275518 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Attenuated Bacteria Vaccine | Attenuated Live Virus Vaccine
Item
12. have received any live bacterial or live viral vaccination in the last12 weeks.
boolean
C1879753 (UMLS CUI [1])
C1516086 (UMLS CUI [2])
BCG Vaccine
Item
13. have received bacille calmette-guerin (bcg) vaccination in the last 12 months.
boolean
C0004886 (UMLS CUI [1])
Therapeutic procedure Ustekinumab Stelara
Item
14. have received treatment with ustekinumab (stelara®).
boolean
C0087111 (UMLS CUI [1,1])
C1608841 (UMLS CUI [1,2])
C2702169 (UMLS CUI [1,3])
Other Biological Products
Item
15. have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.
boolean
C0205394 (UMLS CUI [1,1])
C0005522 (UMLS CUI [1,2])
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