ID

13382

Descripción

Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00046748

Link

https://clinicaltrials.gov/show/NCT00046748

Palabras clave

Versiones (1)
  1. 10/2/16 10/2/16 -
Subido en

10 de febrero de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Asthma NCT00046748

Inglés

Eligibility Asthma NCT00046748

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00046748
Criteria
Descripción

Criteria

With a positive prick skin test (diameter of wheal > 3 mm) to at least one perennial allergen (e.g. dust mite, animal dander, cockroaches), within the past 5 years or at visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study. a rast test may be performed for patients with a borderline skin prick test result.
Descripción

positive prick skin test to perennial allergen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430561
UMLS CUI [1,2]
C0002092
UMLS CUI [1,3]
C0330103
UMLS CUI [1,4]
C1446409
UMLS CUI [2]
C0034554
With total serum ige level 30 to 700 iu/ml.
Descripción

serum IgE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2229760
Demonstrating 12% increase in fev1 over baseline value within 30 minutes of taking up to 4 puffs salbutamol (albuterol) or nebulized salbutamol up to 5mg (or equivalent of alternative b-2 agonist) documented within the past year, at screening, during the run-in period or at baseline prior to randomization.
Descripción

FEV1 increase taking salbutamol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0001927
With fev1 40-80% of predicted normal value for the patient (demonstrable at least 6 hours after short acting b-2 agonist use or 12 hours after long acting b-2 agonist use) at baseline.
Descripción

FEV1 predicted normal value

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0086715
Who have either experienced at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year.
Descripción

two independent asthma exacerbations or clinical intervention with systematic corticosteroid

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2,1]
C0205373
UMLS CUI [2,2]
C0001617
Been admitted to hospital (including intensive care unit) or received emergency room (including urgent care centers) treatment in the past 12 months for an asthma exacerbation, which in accordance with the gina guidelines met all of the following criteria for a severe exacerbation:
Descripción

hospital admission or emergency room met criteria of severe exacerbation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0349790
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C2065341
UMLS CUI [2,2]
C0349790
UMLS CUI [2,3]
C0205082
1. pef or fev1< 60% of predicted/personal best, or patient is too breathless to provide pef.
Descripción

PEF or FEV1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0521299
UMLS CUI [2]
C0748133
2. no improvement after initial treatment and therefore requiring repeated treatment with inhaled b-2 agonist (high dose, spacer or nebulized).
Descripción

no improvement after initial treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3844714
UMLS CUI [2,1]
C2936790
UMLS CUI [2,2]
C1524062
UMLS CUI [2,3]
C0686904
3. requiring treatment with systemic corticosteroids
Descripción

treatment with systemic corticosteroids

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205373
UMLS CUI [1,2]
C0001617
Receiving high dose inhaled corticosteroid (at least 1000ug beclomethasone dipropionate or equivalent) and a regular inhaled long acting b-2 agonist for at least 3 months prior to screening and prior to at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year or the severe asthma exacerbation requiring the hospitalization/er visit.
Descripción

high dose inhaled corticosteroid

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0001559
UMLS CUI [1,3]
C0444956
Who are receiving an ics dosage > 1000ug beclomethasone dipropionate or equivalent and a regular inhaled long acting b-2 agonist for the last 4 weeks of the run-in period and at randomization (to be maintained throughout the study).
Descripción

ICS or beclomethasone dipropionate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3248292
UMLS CUI [2]
C0004906
Whose asthma medication remains unchanged in the final 4 weeks of the run-in period (to be maintained throughout the study).
Descripción

asthma medication remains unchanged

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0442739
With evidence of poor asthma symptom control at screening (based on patient history) and during the 4 weeks immediately prior to baseline.
Descripción

evidence of poor asthma symptom control

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1318955
UMLS CUI [1,2]
C0542537
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Similar models

Eligibility Asthma NCT00046748

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00046748
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
positive prick skin test to perennial allergen
Item
With a positive prick skin test (diameter of wheal > 3 mm) to at least one perennial allergen (e.g. dust mite, animal dander, cockroaches), within the past 5 years or at visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study. a rast test may be performed for patients with a borderline skin prick test result.
boolean
C0430561 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0330103 (UMLS CUI [1,3])
C1446409 (UMLS CUI [1,4])
C0034554 (UMLS CUI [2])
serum IgE
Item
With total serum ige level 30 to 700 iu/ml.
boolean
C2229760 (UMLS CUI [1])
FEV1 increase taking salbutamol
Item
Demonstrating 12% increase in fev1 over baseline value within 30 minutes of taking up to 4 puffs salbutamol (albuterol) or nebulized salbutamol up to 5mg (or equivalent of alternative b-2 agonist) documented within the past year, at screening, during the run-in period or at baseline prior to randomization.
boolean
C0748133 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0001927 (UMLS CUI [1,3])
FEV1 predicted normal value
Item
With fev1 40-80% of predicted normal value for the patient (demonstrable at least 6 hours after short acting b-2 agonist use or 12 hours after long acting b-2 agonist use) at baseline.
boolean
C0748133 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
two independent asthma exacerbations or clinical intervention with systematic corticosteroid
Item
Who have either experienced at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year.
boolean
C0349790 (UMLS CUI [1])
C0205373 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
hospital admission or emergency room met criteria of severe exacerbation
Item
Been admitted to hospital (including intensive care unit) or received emergency room (including urgent care centers) treatment in the past 12 months for an asthma exacerbation, which in accordance with the gina guidelines met all of the following criteria for a severe exacerbation:
boolean
C0184666 (UMLS CUI [1,1])
C0349790 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C2065341 (UMLS CUI [2,1])
C0349790 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
PEF or FEV1
Item
1. pef or fev1< 60% of predicted/personal best, or patient is too breathless to provide pef.
boolean
C0521299 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
no improvement after initial treatment
Item
2. no improvement after initial treatment and therefore requiring repeated treatment with inhaled b-2 agonist (high dose, spacer or nebulized).
boolean
C3844714 (UMLS CUI [1])
C2936790 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
treatment with systemic corticosteroids
Item
3. requiring treatment with systemic corticosteroids
boolean
C0205373 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
high dose inhaled corticosteroid
Item
Receiving high dose inhaled corticosteroid (at least 1000ug beclomethasone dipropionate or equivalent) and a regular inhaled long acting b-2 agonist for at least 3 months prior to screening and prior to at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year or the severe asthma exacerbation requiring the hospitalization/er visit.
boolean
C0001617 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0444956 (UMLS CUI [1,3])
ICS or beclomethasone dipropionate
Item
Who are receiving an ics dosage > 1000ug beclomethasone dipropionate or equivalent and a regular inhaled long acting b-2 agonist for the last 4 weeks of the run-in period and at randomization (to be maintained throughout the study).
boolean
C3248292 (UMLS CUI [1])
C0004906 (UMLS CUI [2])
asthma medication remains unchanged
Item
Whose asthma medication remains unchanged in the final 4 weeks of the run-in period (to be maintained throughout the study).
boolean
C0087111 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
evidence of poor asthma symptom control
Item
With evidence of poor asthma symptom control at screening (based on patient history) and during the 4 weeks immediately prior to baseline.
boolean
C1318955 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
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