ID

14364

Description

Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS; ODM derived from: https://clinicaltrials.gov/show/NCT00486343

Link

https://clinicaltrials.gov/show/NCT00486343

Keywords

Versions (1)
  1. 4/12/16 4/12/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 12, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00486343

English

Eligibility Asthma NCT00486343

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00486343
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female 12-70 years of age (inclusive).
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of asthma for at least 6 months.
Description

asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040223
3. morning fev1 of 40-80% normal.
Description

morning fev1

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0332170
4. demonstrated reversible airflow restriction.
Description

reversible airflow restriction

Data type

boolean

Alias
UMLS CUI [1,1]
C1527303
UMLS CUI [1,2]
C0205343
5. non-smokers.
Description

non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
6. on moderate doses of ics with inadequate asthma control.
Description

ics

Data type

boolean

Alias
UMLS CUI [1]
C3248292
7. signed icf
Description

signed icf

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. diagnosis of copd.
Description

copd

Data type

boolean

Alias
UMLS CUI [1]
C0024117
2. uncontrolled systemic illness.
Description

uncontrolled systemic illness

Data type

boolean

Alias
UMLS CUI [1]
C0009488
3. hypersensitivity to any component of zyflo cr
Description

hypersensitivity to any component of zyflo cr

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1951657
4. any patient with an unscheduled visit to an er or hospital for asthma exacerbation within past 3 months.
Description

asthma exacerbation with an unscheduled visit to an er or hospital

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0040223
UMLS CUI [3]
C0583237
UMLS CUI [4]
C0019993
5. history of hepatitis or active liver disease.
Description

hepatitis or acute liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0023895
6. alt greater than 3xuln.
Description

ALT

Data type

boolean

Alias
UMLS CUI [1]
C0201836
7. history of hiv infection
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019682
8. recent history of drug or alcohol abuse.
Description

history of drug or alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
9. oral corticosteroids within one month, cromolyn sodium or nedocromil within 14 days, theophylline, laba, zyflo, or leukotriene modifiers, warfarin or propranolol, inhaled anti-cholinergics, or combination laba/ics.
Description

oral corticosteroids within one month, cromolyn sodium or nedocromil within 14 days, theophylline, laba, zyflo, or leukotriene modifiers, warfarin or propranolol, inhaled anti-cholinergics, or combination laba/ics

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0012694
UMLS CUI [3]
C0068483
UMLS CUI [4]
C0039771
UMLS CUI [5]
C2936789
UMLS CUI [6]
C0595726
UMLS CUI [7]
C0724508
UMLS CUI [8]
C0043031
UMLS CUI [9]
C0033497
UMLS CUI [10]
C0354764
10. omalizumab within 3 months.
Description

omalizumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0966225
UMLS CUI [1,2]
C1514463
11. pregnant female.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
12. participation with 30 days in investigational study.
Description

participation with 30 days in investigational study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Asthma NCT00486343

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00486343
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. male or female 12-70 years of age (inclusive).
boolean
C0001779 (UMLS CUI [1])
asthma
Item
2. diagnosis of asthma for at least 6 months.
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
morning fev1
Item
3. morning fev1 of 40-80% normal.
boolean
C0748133 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
reversible airflow restriction
Item
4. demonstrated reversible airflow restriction.
boolean
C1527303 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
non-smoker
Item
5. non-smokers.
boolean
C0337672 (UMLS CUI [1])
ics
Item
6. on moderate doses of ics with inadequate asthma control.
boolean
C3248292 (UMLS CUI [1])
signed icf
Item
7. signed icf
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
copd
Item
1. diagnosis of copd.
boolean
C0024117 (UMLS CUI [1])
uncontrolled systemic illness
Item
2. uncontrolled systemic illness.
boolean
C0009488 (UMLS CUI [1])
hypersensitivity to any component of zyflo cr
Item
3. hypersensitivity to any component of zyflo cr
boolean
C0020517 (UMLS CUI [1,1])
C1951657 (UMLS CUI [1,2])
asthma exacerbation with an unscheduled visit to an er or hospital
Item
4. any patient with an unscheduled visit to an er or hospital for asthma exacerbation within past 3 months.
boolean
C0349790 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0583237 (UMLS CUI [3])
C0019993 (UMLS CUI [4])
hepatitis or acute liver disease
Item
5. history of hepatitis or active liver disease.
boolean
C0019158 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
ALT
Item
6. alt greater than 3xuln.
boolean
C0201836 (UMLS CUI [1])
HIV
Item
7. history of hiv infection
boolean
C0019682 (UMLS CUI [1])
history of drug or alcohol abuse
Item
8. recent history of drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
oral corticosteroids within one month, cromolyn sodium or nedocromil within 14 days, theophylline, laba, zyflo, or leukotriene modifiers, warfarin or propranolol, inhaled anti-cholinergics, or combination laba/ics
Item
9. oral corticosteroids within one month, cromolyn sodium or nedocromil within 14 days, theophylline, laba, zyflo, or leukotriene modifiers, warfarin or propranolol, inhaled anti-cholinergics, or combination laba/ics.
boolean
C0001617 (UMLS CUI [1])
C0012694 (UMLS CUI [2])
C0068483 (UMLS CUI [3])
C0039771 (UMLS CUI [4])
C2936789 (UMLS CUI [5])
C0595726 (UMLS CUI [6])
C0724508 (UMLS CUI [7])
C0043031 (UMLS CUI [8])
C0033497 (UMLS CUI [9])
C0354764 (UMLS CUI [10])
omalizumab
Item
10. omalizumab within 3 months.
boolean
C0966225 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
pregnancy
Item
11. pregnant female.
boolean
C0032961 (UMLS CUI [1])
participation with 30 days in investigational study
Item
12. participation with 30 days in investigational study.
boolean
C2348568 (UMLS CUI [1])
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