Informações:
Falhas:
ID
12758
Descrição
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00130351
Link
https://clinicaltrials.gov/show/NCT00130351
Palavras-chave
Versões (1)
- 21/12/2015 21/12/2015 -
Transferido a
21 de dezembro de 2015
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Asthma NCT00130351
Eligibility Asthma NCT00130351
- StudyEvent: Eligibility
Similar models
Eligibility Asthma NCT00130351
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
compliance
Item
patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary
boolean
C1321605 (UMLS CUI [1])
asthma
Item
patients who have a current diagnosis of asthma
boolean
C0004096 (UMLS CUI [1])
Forced expiratory volume in 1 second finding; Bronchodilator Agents
Item
patients who have a documented forced expiratory volume at 1 second (fev1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a >12% increase in fev1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at visit 1. the administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry.
boolean
C0429706 (UMLS CUI [1])
C0006280 (UMLS CUI [2])
C0006280 (UMLS CUI [2])
Study Subject Participation Status
Item
patients who were enrolled in study cfor258f2304 or cfor258f2306, or who have any experience using the certihaler® device.
boolean
C2348568 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
qtc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ecg) that in the opinion of the investigator would present a safety hazard for continuation in the study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
hypersensitivity sympathomimetic amines
Item
patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies
boolean
C0020517 (UMLS CUI [1,1])
C0002509 (UMLS CUI [1,2])
C0002509 (UMLS CUI [1,2])
Study Subject Participation Status
Item
other protocol-defined inclusion and exclusion criteria apply
boolean
C2348568 (UMLS CUI [1])