ID

14299

Description

To Study Device Attributes by Investigating Errors Made in Use, Ease of Use and Preference Among Different Inhalers in Subjects With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02195284

Link

https://clinicaltrials.gov/show/NCT02195284

Keywords

Versions (1)
  1. 4/8/16 4/8/16 -
Uploaded on

April 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT02195284

English

Eligibility Asthma NCT02195284

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02195284
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent: subject must give their signed and dated written informed consent to participate; subject understands and is willing, able, and likely to comply with study procedures and restrictions; subject must be able to read, comprehend, and record information in dutch and/or english
Description

Informed Consent | Compliance behavior | Able to read Comprehension Able to write English Language | Dutch Language

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
UMLS CUI [3,1]
C0586740
UMLS CUI [3,2]
C0162340
UMLS CUI [3,3]
C0584993
UMLS CUI [3,4]
C0376245
UMLS CUI [4,1]
C0586740
UMLS CUI [4,2]
C0162340
UMLS CUI [4,3]
C0584993
UMLS CUI [4,4]
C0376241
age: >=18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
gender: male or female subjects.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
asthma diagnosis: a diagnosis of asthma as defined by the national institutes of health. comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
Description

Asthma | Comorbidity | Rheumatoid Arthritis | Musculoskeletal Diseases | Visual Impairment | Depressive disorder | Anxiety | Inhaler

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0009488
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0026857
UMLS CUI [5]
C3665347
UMLS CUI [6]
C0011581
UMLS CUI [7]
C0003467
UMLS CUI [8]
C0021461
asthma treatment: all subjects should be currently receiving treatment for asthma.
Description

Therapeutic procedure Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
must be naive to using ellipta inhaler and at least one other inhaler device.
Description

Inhaler | Inhaler aid device

Data type

boolean

Alias
UMLS CUI [1]
C0021461
UMLS CUI [2]
C0461716
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic obstructive pulmonary disease (copd): subjects with a current diagnosis of copd only.
Description

Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1]
C0024117
contraindications: a history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
Description

Medical contraindication | Lactose Intolerance | Hypersensitivity Magnesium stearate

Data type

boolean

Alias
UMLS CUI [1]
C1301624
UMLS CUI [2]
C0022951
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0126791
subjects who are currently participating in another randomised pharmacological interventional trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
inability to read: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions
Description

Unable to read | Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1]
C0586741
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
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Similar models

Eligibility Asthma NCT02195284

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02195284
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Compliance behavior | Able to read Comprehension Able to write English Language | Dutch Language
Item
informed consent: subject must give their signed and dated written informed consent to participate; subject understands and is willing, able, and likely to comply with study procedures and restrictions; subject must be able to read, comprehend, and record information in dutch and/or english
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C0586740 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C0584993 (UMLS CUI [3,3])
C0376245 (UMLS CUI [3,4])
C0586740 (UMLS CUI [4,1])
C0162340 (UMLS CUI [4,2])
C0584993 (UMLS CUI [4,3])
C0376241 (UMLS CUI [4,4])
Age
Item
age: >=18 years of age
boolean
C0001779 (UMLS CUI [1])
Gender
Item
gender: male or female subjects.
boolean
C0079399 (UMLS CUI [1])
Asthma | Comorbidity | Rheumatoid Arthritis | Musculoskeletal Diseases | Visual Impairment | Depressive disorder | Anxiety | Inhaler
Item
asthma diagnosis: a diagnosis of asthma as defined by the national institutes of health. comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
boolean
C0004096 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0026857 (UMLS CUI [4])
C3665347 (UMLS CUI [5])
C0011581 (UMLS CUI [6])
C0003467 (UMLS CUI [7])
C0021461 (UMLS CUI [8])
Therapeutic procedure Asthma
Item
asthma treatment: all subjects should be currently receiving treatment for asthma.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
Inhaler | Inhaler aid device
Item
must be naive to using ellipta inhaler and at least one other inhaler device.
boolean
C0021461 (UMLS CUI [1])
C0461716 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Chronic Obstructive Airway Disease
Item
chronic obstructive pulmonary disease (copd): subjects with a current diagnosis of copd only.
boolean
C0024117 (UMLS CUI [1])
Medical contraindication | Lactose Intolerance | Hypersensitivity Magnesium stearate
Item
contraindications: a history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
boolean
C1301624 (UMLS CUI [1])
C0022951 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0126791 (UMLS CUI [3,2])
Study Subject Participation Status
Item
subjects who are currently participating in another randomised pharmacological interventional trial.
boolean
C2348568 (UMLS CUI [1])
Unable to read | Compliance behavior Limited
Item
inability to read: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions
boolean
C0586741 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
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