Information:
Error:
ID
14527
Description
Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00385593
Link
https://clinicaltrials.gov/show/NCT00385593
Keywords
Versions (1)
- 4/19/16 4/19/16 -
Uploaded on
April 19, 2016
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Asthma, Bronchial NCT00385593
Eligibility Asthma, Bronchial NCT00385593
- StudyEvent: Eligibility
Similar models
Eligibility Asthma, Bronchial NCT00385593
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Asthma
Item
minimum of 3 months history of asthma, diagnosed according to the american thoracic society (ats) definition (9).
boolean
C0004096 (UMLS CUI [1])
Glucocorticoids Inhalation | Budesonide
Item
prescribed inhaled gcs at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to visit 1.
boolean
C0017710 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C0054201 (UMLS CUI [2])
C0205535 (UMLS CUI [1,2])
C0054201 (UMLS CUI [2])
Glucocorticoids Inhalation | Adrenergic beta-2 Receptor Agonists
Item
either daily maintenance treatment with both inhaled gcs and laba or daily treatment with inhaled gcs alone (i.e. without laba)
boolean
C0017710 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
C0205535 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
Asthma control suboptimal
Item
a history of suboptimal asthma control the month prior to enrolment as judged by the investigator
boolean
C0004096 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C2984009 (UMLS CUI [1,3])
C0243148 (UMLS CUI [1,2])
C2984009 (UMLS CUI [1,3])
Inhalation Pharmaceutical Preparations | Symptom relieving factors
Item
use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment
boolean
C0205535 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0436323 (UMLS CUI [2])
C0013227 (UMLS CUI [1,2])
C0436323 (UMLS CUI [2])
Prior Therapy Symbicort Inhaler
Item
previous treatment with symbicort single inhaler;
boolean
C1514463 (UMLS CUI [1,1])
C1121854 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,3])
C1121854 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,3])
Adrenergic beta-Antagonists | Eye Drops | Glucocorticoids Oral
Item
use of any b-blocking agent, including eye-drops and oral gcs as maintenance treatment.
boolean
C0001645 (UMLS CUI [1])
C0015399 (UMLS CUI [2])
C0017710 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0015399 (UMLS CUI [2])
C0017710 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
Hypersensitivity Study Therapeutic procedure | Hypersensitivity Pharmaceutical Excipient
Item
known or suspected hypersensitivity to study therapy or excipients.
boolean
C0020517 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
C2603343 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
smoking cigarettes: ____ pack-years history
Item
a history of smoking ≥ 10 pack years.
boolean
C2230126 (UMLS CUI [1])
Exacerbation of asthma | Therapy change Asthma
Item
asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at visit 1.
boolean
C0349790 (UMLS CUI [1])
C3665894 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C3665894 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])