ID

14544

Beskrivning

Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00746330

Länk

https://clinicaltrials.gov/show/NCT00746330

Nyckelord

Versioner (1)
  1. 2016-04-20 2016-04-20 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

20 april 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00746330

Engelsk

Eligibility Asthma NCT00746330

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00746330
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
5 to 11 years of age of either sex and of any race
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
a diagnosis (according to the global initiative for asthma [gina] guidelines) of persistent asthma for a period of at least 6 months prior to screening and must have been on a stable asthma regimen (daily dose unchanged) for at least 4 weeks prior to screening
Beskrivning

persistent asthma and stable asthma regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3266628
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0004096
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0040223
β2-agonist reversibility, defined as an increase in absolute fev1 of ≥12% within 30 minutes after administration of 200μg of salbutamol without the use of a spacer or its equivalent in accordance with ats/ers standards
Beskrivning

fev1 reversibility

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0449261
UMLS CUI [2]
C0001927
a child must have an fev1 of ≥ 60% and ≤ 90% of polgar predicted when all restricted medications have been withheld for the appropriate intervals
Beskrivning

fev1

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer.
Beskrivning

investigational drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0040223
history of malignancy of any organ system within past 5 years.
Beskrivning

history of malignancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0040223
pre-dose change (increase or decrease) in absolute fev1 of 15% at visit 2, compared with value at screening.
Beskrivning

pre-bronchodilator fev1

Datatyp

boolean

Alias
UMLS CUI [1]
C3172227
hospitalized or had an emergency room treatment for an acute asthma exacerbation in the 1 month prior to visit 1, or who had a clinical deterioration of asthma between visits 1 and 2 that resulted in emergency treatment, hospitalization, or treatment with excluded asthma medication.
Beskrivning

asthma exacerbation or deterioration with

Datatyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0019993
UMLS CUI [3]
C0583237
UMLS CUI [4,1]
C0868945
UMLS CUI [4,2]
C0004096
significant medication condition or situation.
Beskrivning

significant medication condition or situation

Datatyp

boolean

qtc > 440 msec (boys) or > 450 msec (girls) on electrocardiogram(ecg) assessment at screening.
Beskrivning

qtc

Datatyp

boolean

Alias
UMLS CUI [1]
C0489625
upper or lower respiratory tract infection within 4 weeks prior to screening.
Beskrivning

upper or lower respiratory tract infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
UMLS CUI [3]
C0040223
chronic conditions affecting the respiratory tract or chronic lung diseases.
Beskrivning

chronic conditions affecting the respiratory tract or chronic lung diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0035237
UMLS CUI [2]
C0746102
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Similar models

Eligibility Asthma NCT00746330

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00746330
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
5 to 11 years of age of either sex and of any race
boolean
C0001779 (UMLS CUI [1])
persistent asthma and stable asthma regimen
Item
a diagnosis (according to the global initiative for asthma [gina] guidelines) of persistent asthma for a period of at least 6 months prior to screening and must have been on a stable asthma regimen (daily dose unchanged) for at least 4 weeks prior to screening
boolean
C3266628 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0040223 (UMLS CUI [2,4])
fev1 reversibility
Item
β2-agonist reversibility, defined as an increase in absolute fev1 of ≥12% within 30 minutes after administration of 200μg of salbutamol without the use of a spacer or its equivalent in accordance with ats/ers standards
boolean
C0748133 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
C0001927 (UMLS CUI [2])
fev1
Item
a child must have an fev1 of ≥ 60% and ≤ 90% of polgar predicted when all restricted medications have been withheld for the appropriate intervals
boolean
C0748133 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
investigational drugs
Item
use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer.
boolean
C0013230 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
history of malignancy
Item
history of malignancy of any organ system within past 5 years.
boolean
C0006826 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
pre-bronchodilator fev1
Item
pre-dose change (increase or decrease) in absolute fev1 of 15% at visit 2, compared with value at screening.
boolean
C3172227 (UMLS CUI [1])
asthma exacerbation or deterioration with
Item
hospitalized or had an emergency room treatment for an acute asthma exacerbation in the 1 month prior to visit 1, or who had a clinical deterioration of asthma between visits 1 and 2 that resulted in emergency treatment, hospitalization, or treatment with excluded asthma medication.
boolean
C0349790 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0583237 (UMLS CUI [3])
C0868945 (UMLS CUI [4,1])
C0004096 (UMLS CUI [4,2])
significant medication condition or situation
Item
significant medication condition or situation.
boolean
qtc
Item
qtc > 440 msec (boys) or > 450 msec (girls) on electrocardiogram(ecg) assessment at screening.
boolean
C0489625 (UMLS CUI [1])
upper or lower respiratory tract infection
Item
upper or lower respiratory tract infection within 4 weeks prior to screening.
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
chronic conditions affecting the respiratory tract or chronic lung diseases
Item
chronic conditions affecting the respiratory tract or chronic lung diseases.
boolean
C0008679 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0035237 (UMLS CUI [1,3])
C0746102 (UMLS CUI [2])
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