ID

43603

Beskrivning

A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00658749

Länk

https://clinicaltrials.gov/show/NCT00658749

Nyckelord

Versioner (2)
  1. 2016-04-18 2016-04-18 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

20 september 2021

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00658749

Engelsk

Eligibility Asthma NCT00658749

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00658749
Criteria
Beskrivning

Criteria

good general health (with or without allergic rhinitis and/or controlled asthma)
Beskrivning

good health

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0205170
non-smoker for at least 2 years
Beskrivning

non-smoker

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0337672
UMLS CUI [1,2]
C0040223
normal lung function (dlco)
Beskrivning

dlco

Datatyp

boolean

Alias
UMLS CUI [1]
C1516251
able to provide informed consent and to understand and comply with the requirements of the study
Beskrivning

informed consent and to understand and comply with the requirements of the study

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
exclusion criteria*:
Beskrivning

exclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
clinically significant medical history or condition which precludes participation
Beskrivning

comorbidity limiting study protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
clinically significant ecg abnormality
Beskrivning

ecg abnormality

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
clinically significant vs or pe abnormality
Beskrivning

vs or pe abnormality

Datatyp

boolean

clinically significant screening lab abnormality
Beskrivning

abnormal laboratory value

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2826293
abnormal lung function (fev1 <80% predicted)
Beskrivning

fev1

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
respiratory infection within 14 days of randomization
Beskrivning

respiratory infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
hbv, hcv, or hiv
Beskrivning

hbv or hcv or hiv

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019682
breastfeeding or pregnant female
Beskrivning

pregnancy or lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of alcohol abuse or illicit drug use within past 24 months
Beskrivning

history of alcohol abuse or illicit drug use

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
use of any tobacco or nicotine-containing product within past 6 months
Beskrivning

smoking history

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
UMLS CUI [1,3]
C0040223
use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol
Beskrivning

herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C1504473
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0304227
use of any investigational drug within past 30 days
Beskrivning

investigational drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0040223
use of any investigational monoclonal antibody or recombinant protein within past 90 days
Beskrivning

monoclonal antibody or recombinant protein

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0034861
UMLS CUI [2,2]
C0013230
donation of plasma within past 7 days
Beskrivning

donation of plasma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0005794
donation or loss of whole blood within past 56 days
Beskrivning

blood donation or loss of blood

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C3163616
UMLS CUI [3]
C0040223
simplified list of i/e criteria; unabridged list available upon request.
Beskrivning

criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0242801
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Similar models

Eligibility Asthma NCT00658749

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00658749
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
good health
Item
good general health (with or without allergic rhinitis and/or controlled asthma)
boolean
C0018759 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
non-smoker
Item
non-smoker for at least 2 years
boolean
C0337672 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
dlco
Item
normal lung function (dlco)
boolean
C1516251 (UMLS CUI [1])
informed consent and to understand and comply with the requirements of the study
Item
able to provide informed consent and to understand and comply with the requirements of the study
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
exclusion criteria
Item
exclusion criteria*:
boolean
C0680251 (UMLS CUI [1])
comorbidity limiting study protocol
Item
clinically significant medical history or condition which precludes participation
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
ecg abnormality
Item
clinically significant ecg abnormality
boolean
C0522055 (UMLS CUI [1])
vs or pe abnormality
Item
clinically significant vs or pe abnormality
boolean
abnormal laboratory value
Item
clinically significant screening lab abnormality
boolean
C1254595 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
fev1
Item
abnormal lung function (fev1 <80% predicted)
boolean
C0748133 (UMLS CUI [1])
respiratory infection
Item
respiratory infection within 14 days of randomization
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
hbv or hcv or hiv
Item
hbv, hcv, or hiv
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
pregnancy or lactation
Item
breastfeeding or pregnant female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
history of alcohol abuse or illicit drug use
Item
history of alcohol abuse or illicit drug use within past 24 months
boolean
C0038586 (UMLS CUI [1])
smoking history
Item
use of any tobacco or nicotine-containing product within past 6 months
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol
Item
use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol
boolean
C1504473 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0304227 (UMLS CUI [3])
investigational drug
Item
use of any investigational drug within past 30 days
boolean
C0013230 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
monoclonal antibody or recombinant protein
Item
use of any investigational monoclonal antibody or recombinant protein within past 90 days
boolean
C0003250 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0034861 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
donation of plasma
Item
donation of plasma within past 7 days
boolean
C0032105 (UMLS CUI [1,1])
C0005794 (UMLS CUI [1,2])
blood donation or loss of blood
Item
donation or loss of whole blood within past 56 days
boolean
C0005794 (UMLS CUI [1])
C3163616 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
criteria
Item
simplified list of i/e criteria; unabridged list available upon request.
boolean
C0242801 (UMLS CUI [1])
Tillbaka till toppen 

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