ID

14544

Description

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

Link

https://clinicaltrials.gov/show/NCT00746330

Keywords

  1. 4/20/16 4/20/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 20, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Asthma NCT00746330

Eligibility Asthma NCT00746330

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00746330
Inclusion Criteria
Description

Inclusion Criteria

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

age

Data type

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
Description

persistent asthma and stable asthma regimen

Data type

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
Description

fev1 reversibility

Data type

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
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
Exclusion Criteria
Description

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.
Description

investigational drugs

Data type

boolean

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

history of malignancy

Data type

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.
Description

pre-bronchodilator fev1

Data type

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.
Description

asthma exacerbation or deterioration with

Data type

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.
Description

significant medication condition or situation

Data type

boolean

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

qtc

Data type

boolean

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

upper or lower respiratory tract infection

Data type

boolean

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

chronic conditions affecting the respiratory tract or chronic lung diseases

Data type

boolean

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

Similar models

Eligibility Asthma NCT00746330

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00746330
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial