ID

13289

Descripción

Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00667407

Link

https://clinicaltrials.gov/show/NCT00667407

Palabras clave

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

31 de enero de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Asthma NCT00667407

Inglés

Eligibility Asthma NCT00667407

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00667407
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
Descripción

gender and age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
subjects must have history of asthma for at least 6 months.
Descripción

asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004096
subjects must present to the emergency department (ed) or clinic with forced expiratory volume in one second (fev1) of 20 to 55% (inclusive) predicted at baseline
Descripción

Pulmonary function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0748133
subjects must have o2 saturation greater than or equal to 90% at room air or with no more than 6 liters/minute supplemental oxygen and no other cause of wheezing or shortness of breath other than asthma as determined by the physician.
Descripción

Symptomatic asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0523807
UMLS CUI [2,1]
C0043144
UMLS CUI [2,2]
C0004096
UMLS CUI [3,1]
C0013404
UMLS CUI [3,2]
C0004096
prior use of a beta-agonist (e.g., primatine mist, albuterol, salmeterol, etc.) within 24 hours of presentation to the ed or clinic.
Descripción

beta-agonist therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001644
smoked ≤ 10 pack-years or non-smoker.
Descripción

smoking status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1277691
be in good health with the exception of asthma and not suffering from any chronic condition which might affect their lung function, such as copd or emphysema.
Descripción

physical status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018759
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0231921
UMLS CUI [3]
C0024117
UMLS CUI [4]
C0034067
near-normal activity level between exacerbations.
Descripción

physical activity level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3694575
subjects who are taking inhaled or systemic corticosteroids must be on a stable dose for at least 21 days prior to study entry.
Descripción

Coricosteroid therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3248292
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1971485
UMLS CUI [2,2]
C0178602
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have received treatment for asthma in an ed, clinic, or urgent care center within 2 weeks prior to study entry.
Descripción

emergency treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013969
UMLS CUI [1,2]
C0004096
based upon history or physical exam in the ed or clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as copd, chf, pneumonia, pulmonary embolism, or angioedema.
Descripción

Pulmonary comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0032285
UMLS CUI [4]
C0034065
UMLS CUI [5]
C0002994
subjects with a history of asthma episodes associated with hypercapnia, respiratory arrest, hypoxic seizures, or requiring intubation within 12 months prior to entry.
Descripción

asthma episodes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020440
UMLS CUI [2]
C0162297
UMLS CUI [3]
C0036572
UMLS CUI [4]
C0021925
hospitalization for asthma within two months prior to entry.
Descripción

hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004096
female subjects who are pregnant or lactating.
Descripción

gynaecological status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects who have a history of a clinically significant psychiatric disorder within the last 3 months, with the exception of mild depression.
Descripción

Mental status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0588006
subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
Descripción

Paticipation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Asthma NCT00667407

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00667407
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
gender and age
Item
male and female subjects must be at least greater than or equal to 18 years of age at the time of consent.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
asthma
Item
subjects must have history of asthma for at least 6 months.
boolean
C0004096 (UMLS CUI [1])
Pulmonary function
Item
subjects must present to the emergency department (ed) or clinic with forced expiratory volume in one second (fev1) of 20 to 55% (inclusive) predicted at baseline
boolean
C0748133 (UMLS CUI [1])
Symptomatic asthma
Item
subjects must have o2 saturation greater than or equal to 90% at room air or with no more than 6 liters/minute supplemental oxygen and no other cause of wheezing or shortness of breath other than asthma as determined by the physician.
boolean
C0523807 (UMLS CUI [1])
C0043144 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0013404 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
beta-agonist therapy
Item
prior use of a beta-agonist (e.g., primatine mist, albuterol, salmeterol, etc.) within 24 hours of presentation to the ed or clinic.
boolean
C0001644 (UMLS CUI [1])
smoking status
Item
smoked ≤ 10 pack-years or non-smoker.
boolean
C1277691 (UMLS CUI [1])
physical status
Item
be in good health with the exception of asthma and not suffering from any chronic condition which might affect their lung function, such as copd or emphysema.
boolean
C0018759 (UMLS CUI [1])
C0008679 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0231921 (UMLS CUI [2,3])
C0024117 (UMLS CUI [3])
C0034067 (UMLS CUI [4])
physical activity level
Item
near-normal activity level between exacerbations.
boolean
C3694575 (UMLS CUI [1])
Coricosteroid therapy
Item
subjects who are taking inhaled or systemic corticosteroids must be on a stable dose for at least 21 days prior to study entry.
boolean
C3248292 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1971485 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
emergency treatment
Item
subjects who have received treatment for asthma in an ed, clinic, or urgent care center within 2 weeks prior to study entry.
boolean
C0013969 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
Pulmonary comorbidity
Item
based upon history or physical exam in the ed or clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as copd, chf, pneumonia, pulmonary embolism, or angioedema.
boolean
C0024117 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0032285 (UMLS CUI [3])
C0034065 (UMLS CUI [4])
C0002994 (UMLS CUI [5])
asthma episodes
Item
subjects with a history of asthma episodes associated with hypercapnia, respiratory arrest, hypoxic seizures, or requiring intubation within 12 months prior to entry.
boolean
C0020440 (UMLS CUI [1])
C0162297 (UMLS CUI [2])
C0036572 (UMLS CUI [3])
C0021925 (UMLS CUI [4])
hospitalization
Item
hospitalization for asthma within two months prior to entry.
boolean
C0019993 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
gynaecological status
Item
female subjects who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental status
Item
subjects who have a history of a clinically significant psychiatric disorder within the last 3 months, with the exception of mild depression.
boolean
C0004936 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0588006 (UMLS CUI [1,3])
Paticipation status
Item
subjects who have participated in an investigational drug study within 30 days of study entry or have previously participated in the current trial.
boolean
C2348568 (UMLS CUI [1])
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