ID

14381

Beschrijving

Inhaler Adherence in Poorly Controlled Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02307669

Link

https://clinicaltrials.gov/show/NCT02307669

Trefwoorden

Versies (1)
  1. 12-04-16 12-04-16 -
Geüploaded op

12 april 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Asthma NCT02307669

Engels

Eligibility Asthma NCT02307669

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02307669
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be willing to give voluntary informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
must have a clinical diagnosis of asthma-
Beschrijving

Asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0004096
must have a bronchodilator fev1 > 40% and <80% in the past 1 year
Beschrijving

FEV1 Bronchodilator Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0006280
current unstable asthma i.e. act score is less than 19 at enrolment.
Beschrijving

Unstable status Asthma | Asthma control test score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C2733224
two or more courses of oral corticosteroids in the prior year, or a hospitalization or ed attendance with an asthma exacerbation in the last year
Beschrijving

Adrenal Cortex Hormones | Hospitalization | Emergency room admission Exacerbation of asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0019993
UMLS CUI [3,1]
C0583237
UMLS CUI [3,2]
C0349790
age 18 years or older at time of consent.
Beschrijving

Age | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
capable of understanding and complying with the requirements of the protocol, including ability to attend for all required visits.
Beschrijving

Compliance behavior Comprehension

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0162340
able and willing to take inhaled medication via a diskus.
Beschrijving

Ability Take Inhalation preparations Diskus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1515187
UMLS CUI [1,3]
C0354922
UMLS CUI [1,4]
C1553480
in the opinion of the investigator suitable for use of a salmeterol/fluticasone diskus inhaler or already using a salmeterol/fluticasone inhaler.
Beschrijving

Use of salmeterol Inhaler | Use of fluticasone Inhaler | Diskus

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0073992
UMLS CUI [1,3]
C0021461
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0082607
UMLS CUI [2,3]
C0021461
UMLS CUI [3]
C1553480
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
have used any investigational product or device within 3 months of the enrolment visit.
Beschrijving

Use of Investigational product | Use of Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1517586
UMLS CUI [1,3]
C1514468
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C2346570
have known previous sensitivity to seretide.
Beschrijving

Hypersensitivity Seretide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1130494
have a known significant (in the opinion of the investigator) concurrent medical disease that might mean that the participant cannot complete the year long observation study.
Beschrijving

Comorbidity Study Subject Participation Status Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
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Similar models

Eligibility Asthma NCT02307669

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02307669
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
must be willing to give voluntary informed consent
boolean
C0021430 (UMLS CUI [1])
Asthma
Item
must have a clinical diagnosis of asthma-
boolean
C0004096 (UMLS CUI [1])
FEV1 Bronchodilator Agents
Item
must have a bronchodilator fev1 > 40% and <80% in the past 1 year
boolean
C0748133 (UMLS CUI [1,1])
C0006280 (UMLS CUI [1,2])
Unstable status Asthma | Asthma control test score
Item
current unstable asthma i.e. act score is less than 19 at enrolment.
boolean
C0443343 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C2733224 (UMLS CUI [2])
Adrenal Cortex Hormones | Hospitalization | Emergency room admission Exacerbation of asthma
Item
two or more courses of oral corticosteroids in the prior year, or a hospitalization or ed attendance with an asthma exacerbation in the last year
boolean
C0001617 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0583237 (UMLS CUI [3,1])
C0349790 (UMLS CUI [3,2])
Age | Informed Consent
Item
age 18 years or older at time of consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Compliance behavior Comprehension
Item
capable of understanding and complying with the requirements of the protocol, including ability to attend for all required visits.
boolean
C1321605 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
Ability Take Inhalation preparations Diskus
Item
able and willing to take inhaled medication via a diskus.
boolean
C0085732 (UMLS CUI [1,1])
C1515187 (UMLS CUI [1,2])
C0354922 (UMLS CUI [1,3])
C1553480 (UMLS CUI [1,4])
Use of salmeterol Inhaler | Use of fluticasone Inhaler | Diskus
Item
in the opinion of the investigator suitable for use of a salmeterol/fluticasone diskus inhaler or already using a salmeterol/fluticasone inhaler.
boolean
C1524063 (UMLS CUI [1,1])
C0073992 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0082607 (UMLS CUI [2,2])
C0021461 (UMLS CUI [2,3])
C1553480 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Use of Investigational product | Use of Investigational Medical Device
Item
have used any investigational product or device within 3 months of the enrolment visit.
boolean
C1524063 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C1514468 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C2346570 (UMLS CUI [2,2])
Hypersensitivity Seretide
Item
have known previous sensitivity to seretide.
boolean
C0020517 (UMLS CUI [1,1])
C1130494 (UMLS CUI [1,2])
Comorbidity Study Subject Participation Status Limited
Item
have a known significant (in the opinion of the investigator) concurrent medical disease that might mean that the participant cannot complete the year long observation study.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
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