Informações:
Falhas:
ID
13529
Descrição
Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115); ODM derived from: https://clinicaltrials.gov/show/NCT01026870
Link
https://clinicaltrials.gov/show/NCT01026870
Palavras-chave
Versões (1)
- 13/02/2016 13/02/2016 -
Transferido a
13 de fevereiro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Asthma NCT01026870
Eligibility Asthma NCT01026870
- StudyEvent: Eligibility
Similar models
Eligibility Asthma NCT01026870
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
adolescent; persistent asthma
Item
an adult or adolescent subject with a diagnosis of persistent asthma of >=6 months duration may be selected for this study.
boolean
C0205653 (UMLS CUI [1])
C3266628 (UMLS CUI [2])
C3266628 (UMLS CUI [2])
Therapy change
Item
both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk.
boolean
C3665894 (UMLS CUI [1])
inhaled corticosteroids; Adrenergic beta-2 Receptor Agonists; regimen
Item
subject must have been using a low daily maintenance dose of inhaled corticosteroids (ics), with or without added long-acting β2-agonist (laba), for >=12 weeks prior to screening, and must have been on a stable regimen (daily dose unchanged) for at least the last 2 weeks of that period.
boolean
C3248292 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
C0040808 (UMLS CUI [3])
C2936789 (UMLS CUI [2])
C0040808 (UMLS CUI [3])
prebronchodilator fev1
Item
at screening, the subject must have a prebronchodilator fev1 between 60% and 90% of the predicted value when restricted medications have been withheld.
boolean
C1276012 (UMLS CUI [1])
fev1
Item
to be randomized, the subjects must be symptomatic with fev1 at baseline must be between 50% and 85% of predicted.
boolean
C0802965 (UMLS CUI [1])
Airway Management; Airway Obstruction; Hospitalization
Item
a subject must not have been admitted to the hospital for management of airway obstruction within the last 3 months prior to screening, and must not have experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication, as judged by the clinical investigator at any time from screening to baseline/randomization.
boolean
C0150126 (UMLS CUI [1])
C0001883 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
C0001883 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
peak expiratory flow
Item
in addition, a subject must not have demonstrated a decrease in absolute fev1 of >20% at any time from screening to baseline, or a decrease in am peak expiratory flow (pef) below the pef stability limit on any 2 consecutive days prior to baseline/randomization.
boolean
C0030735 (UMLS CUI [1])