ID

13561

Descrição

A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241 AM3); ODM derived from: https://clinicaltrials.gov/show/NCT01471340

Link

https://clinicaltrials.gov/show/NCT01471340

Palavras-chave

Versões (1)
  1. 15/02/2016 15/02/2016 -
Transferido a

15 de fevereiro de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Asthma NCT01471340

Inglês

Eligibility Asthma NCT01471340

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01471340
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
persistent asthma for at least 1-year
Descrição

persistent asthma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3266628
must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ics) with or without a long-acting beta agonist (laba) or other adjunctive asthma therapy or be using a leukotriene receptor antagonist (ltra), xanthine or short acting beta agonist (saba) as a monotherapy.
Descrição

asthma therapy; corticosteroid

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C3536709
must be able to discontinue current asthma medication
Descrição

medication asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096
must have a history of at least one asthma exacerbation in previous 4 to 52 weeks
Descrição

asthma exacerbation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0349790
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
unstable asthma
Descrição

Unstable status asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0004096
taking high dose ics with or without other adjunctive therapy who have an asthma control questionnaire 6 (acq6) total score ≥ 1.5
Descrição

corticosteroid; Adjuvant therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0677850
taking ltra, xanthine or saba monotherapy with an acq-6 total score < 1.5 (controlled)
Descrição

xanthine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3541955
chronic obstructive pulmonary disease (copd), cystic fibrosis (cf), or other significant, non-asthmatic, lung disease
Descrição

comorbidity Lung diseases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0024115
clinically significant abnormality, illness or disorder of any body or organ system
Descrição

comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
significant underlying cardiovascular condition which may contraindicate use of a beta-agonist.
Descrição

comorbidity Cardiovascular Diseases; medication contraindication beta agonist

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0007222
UMLS CUI [2,1]
C3699431
UMLS CUI [2,2]
C0001644
history of smoking greater than 10-pack years
Descrição

smoking status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519386
had an asthma exacerbation within 4 weeks of the baseline visit
Descrição

asthma exacerbation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0349790
had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the randomization visit
Descrição

asthma exacerbation hospitalization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0019993
known or suspected hypersensitivity or intolerance to corticosteroids, beta-2 agonists, or any of the (inactive ingredients) excipients present in the medications used in this study
Descrição

hypersensitivity corticosteroids

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001617
require the use of chronic systemic steroids, omalizumab, or other monoclonal or polyclonal antibodies
Descrição

antibodies; systemic steroids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003241
UMLS CUI [2]
C2825233
requires the use of beta-blockers
Descrição

beta-blockers

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304516
history of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring noninvasive ventilatory support
Descrição

severe asthma; intubation; hypercapnia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2]
C0021925
UMLS CUI [3]
C0020440
lactating, pregnant, or plans to become pregnant during the course of the trial
Descrição

pregnancy; lactating

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Voltar ao início da página

Similar models

Eligibility Asthma NCT01471340

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01471340
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
persistent asthma
Item
persistent asthma for at least 1-year
boolean
C3266628 (UMLS CUI [1])
asthma therapy; corticosteroid
Item
must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ics) with or without a long-acting beta agonist (laba) or other adjunctive asthma therapy or be using a leukotriene receptor antagonist (ltra), xanthine or short acting beta agonist (saba) as a monotherapy.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C3536709 (UMLS CUI [2])
medication asthma
Item
must be able to discontinue current asthma medication
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
asthma exacerbation
Item
must have a history of at least one asthma exacerbation in previous 4 to 52 weeks
boolean
C0349790 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Unstable status asthma
Item
unstable asthma
boolean
C0443343 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
corticosteroid; Adjuvant therapy
Item
taking high dose ics with or without other adjunctive therapy who have an asthma control questionnaire 6 (acq6) total score ≥ 1.5
boolean
C0001617 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
xanthine
Item
taking ltra, xanthine or saba monotherapy with an acq-6 total score < 1.5 (controlled)
boolean
C3541955 (UMLS CUI [1])
comorbidity Lung diseases
Item
chronic obstructive pulmonary disease (copd), cystic fibrosis (cf), or other significant, non-asthmatic, lung disease
boolean
C0009488 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
comorbidity
Item
clinically significant abnormality, illness or disorder of any body or organ system
boolean
C0009488 (UMLS CUI [1])
comorbidity Cardiovascular Diseases; medication contraindication beta agonist
Item
significant underlying cardiovascular condition which may contraindicate use of a beta-agonist.
boolean
C0009488 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
C3699431 (UMLS CUI [2,1])
C0001644 (UMLS CUI [2,2])
smoking status
Item
history of smoking greater than 10-pack years
boolean
C1519386 (UMLS CUI [1])
asthma exacerbation
Item
had an asthma exacerbation within 4 weeks of the baseline visit
boolean
C0349790 (UMLS CUI [1])
asthma exacerbation hospitalization
Item
had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the randomization visit
boolean
C0349790 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
hypersensitivity corticosteroids
Item
known or suspected hypersensitivity or intolerance to corticosteroids, beta-2 agonists, or any of the (inactive ingredients) excipients present in the medications used in this study
boolean
C0020517 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
antibodies; systemic steroids
Item
require the use of chronic systemic steroids, omalizumab, or other monoclonal or polyclonal antibodies
boolean
C0003241 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
beta-blockers
Item
requires the use of beta-blockers
boolean
C0304516 (UMLS CUI [1])
severe asthma; intubation; hypercapnia
Item
history of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring noninvasive ventilatory support
boolean
C0581126 (UMLS CUI [1])
C0021925 (UMLS CUI [2])
C0020440 (UMLS CUI [3])
pregnancy; lactating
Item
lactating, pregnant, or plans to become pregnant during the course of the trial
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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