ID

14095

Beskrivning

Targeted Small Airways Therapy in Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01894048

Länk

https://clinicaltrials.gov/show/NCT01894048

Nyckelord

Versioner (1)
  1. 2016-03-29 2016-03-29 -
Uppladdad den

29 mars 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Asthma NCT01894048

Engelsk

Eligibility Asthma NCT01894048

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01894048
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female volunteers aged 18-65, with persistent asthma
Beskrivning

Age | Gender | Persistent asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0079399
UMLS CUI [1,3]
C3266628
asthma control questionnaire score >1.0 (at end of run-in)
Beskrivning

Score | Asthma control questionnaire

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C2919686
fev1 >60 percent predicted
Beskrivning

FEV1

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
r5>130% predicted and r5-r20>0.03kpa/l/s
Beskrivning

Total airway resistance | Airway Resistance | Small airways

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232024
UMLS CUI [1,2]
C0001884
UMLS CUI [1,3]
C1862763
ability to perform spirometry, impulse oscillometry, bronchial challenge and all domiciliary measurements
Beskrivning

Ability | Spirometry | impulse oscillometry | Bronchial Provocation Tests | Domiciliary Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0037981
UMLS CUI [1,3]
C3517156
UMLS CUI [1,4]
C0006265
UMLS CUI [1,5]
C0242485
UMLS CUI [1,6]
C0338047
ability to give informed consent
Beskrivning

Ability | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0021430
asthmatic patients receiving treatment at step 2, 3, or 4 of british thoracic society asthma guidelines
Beskrivning

Asthma | Therapeutic procedure | treatment guideline

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0935576
ability to withhold long-acting beta-agonists for the duration of the study
Beskrivning

Ability | Withholding Treatment | Adrenergic beta-Agonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0871549
UMLS CUI [1,3]
C0001644
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients already receiving extra-fine particle inhaled corticosteroids (qvar, fostair, alvesco)
Beskrivning

inhaled steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0731268
UMLS CUI [2]
C1174745
pregnancy or lactation
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known or suspected sensitivity to the investigational medicinal product
Beskrivning

Hypersensitivity | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
inability to comply with protocol
Beskrivning

Compliance behavior | Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol
Beskrivning

Compliance behavior | Limited | Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
an asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement
Beskrivning

Exacerbation of asthma | systemic steroids | Lower respiratory tract infection | Antibiotics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0332121
UMLS CUI [1,3]
C2825233
UMLS CUI [2,1]
C0149725
UMLS CUI [2,2]
C0003232
participation in previous trial within 30 days
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Asthma NCT01894048

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01894048
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender | Persistent asthma
Item
male and female volunteers aged 18-65, with persistent asthma
boolean
C0001779 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C3266628 (UMLS CUI [1,3])
Score | Asthma control questionnaire
Item
asthma control questionnaire score >1.0 (at end of run-in)
boolean
C0449820 (UMLS CUI [1,1])
C2919686 (UMLS CUI [1,2])
FEV1
Item
fev1 >60 percent predicted
boolean
C0748133 (UMLS CUI [1])
Total airway resistance | Airway Resistance | Small airways
Item
r5>130% predicted and r5-r20>0.03kpa/l/s
boolean
C0232024 (UMLS CUI [1,1])
C0001884 (UMLS CUI [1,2])
C1862763 (UMLS CUI [1,3])
Ability | Spirometry | impulse oscillometry | Bronchial Provocation Tests | Domiciliary Measurement
Item
ability to perform spirometry, impulse oscillometry, bronchial challenge and all domiciliary measurements
boolean
C0085732 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
C3517156 (UMLS CUI [1,3])
C0006265 (UMLS CUI [1,4])
C0242485 (UMLS CUI [1,5])
C0338047 (UMLS CUI [1,6])
Ability | Informed Consent
Item
ability to give informed consent
boolean
C0085732 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Asthma | Therapeutic procedure | treatment guideline
Item
asthmatic patients receiving treatment at step 2, 3, or 4 of british thoracic society asthma guidelines
boolean
C0004096 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0935576 (UMLS CUI [1,3])
Ability | Withholding Treatment | Adrenergic beta-Agonists
Item
ability to withhold long-acting beta-agonists for the duration of the study
boolean
C0085732 (UMLS CUI [1,1])
C0871549 (UMLS CUI [1,2])
C0001644 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
inhaled steroids
Item
patients already receiving extra-fine particle inhaled corticosteroids (qvar, fostair, alvesco)
boolean
C2065041 (UMLS CUI [1,1])
C0731268 (UMLS CUI [1,2])
C1174745 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity | Investigational New Drugs
Item
known or suspected sensitivity to the investigational medicinal product
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Compliance behavior | Limited
Item
inability to comply with protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Compliance behavior | Limited | Comorbidity
Item
any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Exacerbation of asthma | systemic steroids | Lower respiratory tract infection | Antibiotics
Item
an asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement
boolean
C0349790 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C0149725 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
Study Subject Participation Status
Item
participation in previous trial within 30 days
boolean
C2348568 (UMLS CUI [1])
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