ID

43963

Descripción

A Study to Evaluate the Effect of AF-219 on Methacholine Hyper-reactivity in Subjects With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01993329

Link

https://clinicaltrials.gov/show/NCT01993329

Palabras clave

  1. 2/4/16 2/4/16 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :


Sin comentarios

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Asthma NCT01993329

Eligibility Asthma NCT01993329

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01993329
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-smokers or former smokers, who stopped smoking 6 months prior to screening. former smokers should not have a smoking history of more than 5 pack years (1 pack of 20 cigarettes per day over 5 years).
Descripción

Non-smoker | Former smoker | Stopped smoking | smoking cigarettes: ____ pack-years history

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0337671
UMLS CUI [2,2]
C0425310
UMLS CUI [2,3]
C2230126
pre-bronchodilator (after abstaining from short acting β2-agonist for ≥8 hrs) forced expiratory volume (fev1) ≥70 percent of the predicted normal value at the screening visit.
Descripción

FEV1 | pre bronchodilator | Adrenergic beta-2 Receptor Agonists

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
UMLS CUI [2]
C2936789
pre-bronchodilator (after abstaining from short acting β2-agonist for ≥8 hrs) forced expiratory volume (fev1) ≥70% of the predicted normal value or if less than 70% must be within +/- 12 % of screening fev1 prior to randomization.
Descripción

FEV1 | pre bronchodilator | Adrenergic beta-2 Receptor Agonists | Trial Screening

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
UMLS CUI [2]
C2936789
UMLS CUI [3]
C1710477
history or diagnosis of asthma for at least 6 months prior to screening according to the global initiative in asthma guidelines (gina, 2012).
Descripción

Asthma | Before screening procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0220908
use of short acting β2-agonist therapy only (≤ 8 puffs per day) for at least 4 weeks prior to screening and prior to randomisation.
Descripción

Adrenergic beta-2 Receptor Agonists | Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2936789
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0220908
UMLS CUI [2]
C0034656
positive response to methacholine challenge (pc20 ≤ 8 mg/ml) at screening.
Descripción

Methacholine challenge | Positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430567
UMLS CUI [1,2]
C1446409
positive response to atp challenge (pc20 ≤ 200 µmol/ml) at screening.
Descripción

Adenosine Triphosphate | Challenge | Positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001480
UMLS CUI [1,2]
C0805586
UMLS CUI [1,3]
C1446409
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
hospitalized or attended the emergency department for an asthma attack in the 12 months prior to screening.
Descripción

Asthma attack | Hospitalization | Emergency room admission

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0347950
UMLS CUI [2]
C0019993
UMLS CUI [3]
C0583237
exacerbation of asthma or lower respiratory tract infection during the 4 weeks before screening.
Descripción

Exacerbation of asthma | Lower respiratory tract infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0149725
upper respiratory tract infection during the 4 weeks before screening or prior to randomization requiring treatment with antibiotics.
Descripción

Treatment required for | Upper Respiratory Infections | Antibiotics

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332121
UMLS CUI [1,2]
C0041912
UMLS CUI [2]
C0003232
inhaled or systemic corticosteroids (oral, intravenous, intramuscular) within 4 weeks prior to screening.
Descripción

Inhaled steroids | systemic steroids | Adrenal Cortex Hormones | Intravenous steroid injection | Intramuscular steroid therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C2825233
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0563322
UMLS CUI [5]
C0585373
short-acting or long-acting antihistamines within 48hrs or 7 days, respectively, prior to screening.
Descripción

Antihistamines

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019590

Similar models

Eligibility Asthma NCT01993329

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01993329
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-smoker | Former smoker | Stopped smoking | smoking cigarettes: ____ pack-years history
Item
non-smokers or former smokers, who stopped smoking 6 months prior to screening. former smokers should not have a smoking history of more than 5 pack years (1 pack of 20 cigarettes per day over 5 years).
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2,1])
C0425310 (UMLS CUI [2,2])
C2230126 (UMLS CUI [2,3])
FEV1 | pre bronchodilator | Adrenergic beta-2 Receptor Agonists
Item
pre-bronchodilator (after abstaining from short acting β2-agonist for ≥8 hrs) forced expiratory volume (fev1) ≥70 percent of the predicted normal value at the screening visit.
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
FEV1 | pre bronchodilator | Adrenergic beta-2 Receptor Agonists | Trial Screening
Item
pre-bronchodilator (after abstaining from short acting β2-agonist for ≥8 hrs) forced expiratory volume (fev1) ≥70% of the predicted normal value or if less than 70% must be within +/- 12 % of screening fev1 prior to randomization.
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
C1710477 (UMLS CUI [3])
Asthma | Before screening procedure
Item
history or diagnosis of asthma for at least 6 months prior to screening according to the global initiative in asthma guidelines (gina, 2012).
boolean
C0004096 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
Adrenergic beta-2 Receptor Agonists | Therapeutic procedure
Item
use of short acting β2-agonist therapy only (≤ 8 puffs per day) for at least 4 weeks prior to screening and prior to randomisation.
boolean
C2936789 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
C0034656 (UMLS CUI [2])
Methacholine challenge | Positive
Item
positive response to methacholine challenge (pc20 ≤ 8 mg/ml) at screening.
boolean
C0430567 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Adenosine Triphosphate | Challenge | Positive
Item
positive response to atp challenge (pc20 ≤ 200 µmol/ml) at screening.
boolean
C0001480 (UMLS CUI [1,1])
C0805586 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Asthma attack | Hospitalization | Emergency room admission
Item
hospitalized or attended the emergency department for an asthma attack in the 12 months prior to screening.
boolean
C0347950 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0583237 (UMLS CUI [3])
Exacerbation of asthma | Lower respiratory tract infection
Item
exacerbation of asthma or lower respiratory tract infection during the 4 weeks before screening.
boolean
C0349790 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
Treatment required for | Upper Respiratory Infections | Antibiotics
Item
upper respiratory tract infection during the 4 weeks before screening or prior to randomization requiring treatment with antibiotics.
boolean
C0332121 (UMLS CUI [1,1])
C0041912 (UMLS CUI [1,2])
C0003232 (UMLS CUI [2])
Inhaled steroids | systemic steroids | Adrenal Cortex Hormones | Intravenous steroid injection | Intramuscular steroid therapy
Item
inhaled or systemic corticosteroids (oral, intravenous, intramuscular) within 4 weeks prior to screening.
boolean
C2065041 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0563322 (UMLS CUI [4])
C0585373 (UMLS CUI [5])
Antihistamines
Item
short-acting or long-acting antihistamines within 48hrs or 7 days, respectively, prior to screening.
boolean
C0019590 (UMLS CUI [1])

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial