ID

14256

Descrizione

A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00207740

collegamento

https://clinicaltrials.gov/show/NCT00207740

Keywords

  1. 05/04/16 05/04/16 -
Titolare del copyright

CC BY-NC 3.0

Caricato su

5 aprile 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00207740

Eligibility Asthma NCT00207740

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00207740
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
physician diagnosis of asthma for greater than or equal to 3 years and a diagnosis of severe persistent asthma forgreater than or equal to 1 year prior to screening
Descrizione

asthma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040223
continuous treatment with high dose inhaled corticosteroids (ics) and long acting beta-agonist for at least 3 months prior to screening
Descrizione

inhaled corticosteroids and LABA

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C2936789
UMLS CUI [3]
C0040223
have evidence of at least 1 of the following in the 5 years prior to screening or during screening, reversible airway obstruction greater than or equal to 12 percentage change in forced expiratory volume in 1 second (fev1) postbronchodilator; diurnal variation in peak expiratory flow rate (pefr) greater than or equal to 30 percentage change) and airway hyperresponsiveness
Descrizione

airway obstruction

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001883
UMLS CUI [2]
C0748133
estimated frequency of symptoms on more than one-third of days for at least 3 months prior to screening (eg, wheezing, breathlessness, chest tightness, cough, nocturnal awakening) despite treatment with high dose ics and long-acting β2-agonist (laba), with or without continuous oral corticosteroids
Descrizione

symptom frequency

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0436350
score of greater than or equal to 2 points on the asthma control questionnaire at screening.
Descrizione

asthma control questionnaire

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2919686
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of chronic obstructive pulmoanry disease (copd), cystic fibrosis, or other significant respiratory disorder
Descrizione

copd, cystic fibrosis or other significant respiratory disorder

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0010674
UMLS CUI [3]
C0035204
worsening of asthma symptoms that required treatment with an addition or increase in oral corticosteroids dose (steroid burst) in the 4-week period prior to the screening visit
Descrizione

worsening of asthma symptoms

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1457868
UMLS CUI [2]
C0001617
life-threatening asthma attack requiring cardiopulmonary support (eg, intubation) in the 6-month period prior to screening
Descrizione

life-threatening asthma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0040223
have ever used alkylating agents (eg, chlorambucil or cyclophosphamide)
Descrizione

alkylating agents

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002073
concomitant diagnosis or any history of congestive heart failure (chf), including medically controlled chf.
Descrizione

congestive heart failure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018802

Similar models

Eligibility Asthma NCT00207740

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00207740
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
asthma
Item
physician diagnosis of asthma for greater than or equal to 3 years and a diagnosis of severe persistent asthma forgreater than or equal to 1 year prior to screening
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
inhaled corticosteroids and LABA
Item
continuous treatment with high dose inhaled corticosteroids (ics) and long acting beta-agonist for at least 3 months prior to screening
boolean
C2065041 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
airway obstruction
Item
have evidence of at least 1 of the following in the 5 years prior to screening or during screening, reversible airway obstruction greater than or equal to 12 percentage change in forced expiratory volume in 1 second (fev1) postbronchodilator; diurnal variation in peak expiratory flow rate (pefr) greater than or equal to 30 percentage change) and airway hyperresponsiveness
boolean
C0001883 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
symptom frequency
Item
estimated frequency of symptoms on more than one-third of days for at least 3 months prior to screening (eg, wheezing, breathlessness, chest tightness, cough, nocturnal awakening) despite treatment with high dose ics and long-acting β2-agonist (laba), with or without continuous oral corticosteroids
boolean
C0436350 (UMLS CUI [1])
asthma control questionnaire
Item
score of greater than or equal to 2 points on the asthma control questionnaire at screening.
boolean
C2919686 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
copd, cystic fibrosis or other significant respiratory disorder
Item
diagnosis of chronic obstructive pulmoanry disease (copd), cystic fibrosis, or other significant respiratory disorder
boolean
C0024117 (UMLS CUI [1])
C0010674 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
worsening of asthma symptoms
Item
worsening of asthma symptoms that required treatment with an addition or increase in oral corticosteroids dose (steroid burst) in the 4-week period prior to the screening visit
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
life-threatening asthma
Item
life-threatening asthma attack requiring cardiopulmonary support (eg, intubation) in the 6-month period prior to screening
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
alkylating agents
Item
have ever used alkylating agents (eg, chlorambucil or cyclophosphamide)
boolean
C0002073 (UMLS CUI [1])
congestive heart failure
Item
concomitant diagnosis or any history of congestive heart failure (chf), including medically controlled chf.
boolean
C0018802 (UMLS CUI [1])

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