ID

14070

Description

Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00829179

Link

https://clinicaltrials.gov/show/NCT00829179

Keywords

Versions (1)
  1. 3/24/16 3/24/16 -
Uploaded on

March 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Allergic Asthma NCT00829179

English

Eligibility Allergic Asthma NCT00829179

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must be at least 18 years of age,
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
must have an fev1 of > 70 percent of predicted,
Description

FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
must have evidence of bronchial hyperreactivity to methacholine as defined by a methacholine provocation causing a 20% or greater fall in fev1 (pc20) < 8 mg/ml
Description

Bronchial hyperreactivity | Methacholine | FEV1

Data type

boolean

Alias
UMLS CUI [1,1]
C0085129
UMLS CUI [1,2]
C0600370
UMLS CUI [1,3]
C0748133
use of inhaled steroid is permitted; however, no change in inhaled steroid dosage will be permitted over the duration of study
Description

Inhaled steroid | Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0586793
UMLS CUI [1,2]
C0178602
must have a normal platelet count,
Description

Platelet count normal

Data type

boolean

Alias
UMLS CUI [1]
C0427564
must be willing to and competent to sign the consent form
Description

Informed consent | Competence

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0086035
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects that do not have allergic asthma will be excluded.
Description

Allergic asthma

Data type

boolean

Alias
UMLS CUI [1]
C0155877
subjects with er visits or upper respiratory infections within the last six weeks will be excluded.
Description

Emergency room visit | Upper Respiratory Infections

Data type

boolean

Alias
UMLS CUI [1]
C2114437
UMLS CUI [2]
C0041912
subjects with tobacco use within the past year or > 10 pack year history of tobacco use will be excluded.
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C2230126
subjects with serum ige levels of less than 30 or greater than 700 iu/ml will be excluded.
Description

serum IgE measurement

Data type

boolean

Alias
UMLS CUI [1]
C2229760
subjects that require oral steroid use will be excluded.
Description

oral steroid

Data type

boolean

Alias
UMLS CUI [1]
C0574135
subjects who weigh < 30 kg or > 150 kg are excluded, and subjects with baseline ige levels greater than 300 may be excluded, depending on weight
Description

Body weight | serum IgE measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C2229760
pregnant or nursing females will be excluded.
Description

Pregnancy | Breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Allergic Asthma NCT00829179

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subjects must be at least 18 years of age,
boolean
C0001779 (UMLS CUI [1])
FEV1
Item
must have an fev1 of > 70 percent of predicted,
boolean
C0748133 (UMLS CUI [1])
Bronchial hyperreactivity | Methacholine | FEV1
Item
must have evidence of bronchial hyperreactivity to methacholine as defined by a methacholine provocation causing a 20% or greater fall in fev1 (pc20) < 8 mg/ml
boolean
C0085129 (UMLS CUI [1,1])
C0600370 (UMLS CUI [1,2])
C0748133 (UMLS CUI [1,3])
Inhaled steroid | Dosage
Item
use of inhaled steroid is permitted; however, no change in inhaled steroid dosage will be permitted over the duration of study
boolean
C0586793 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Platelet count normal
Item
must have a normal platelet count,
boolean
C0427564 (UMLS CUI [1])
Informed consent | Competence
Item
must be willing to and competent to sign the consent form
boolean
C0021430 (UMLS CUI [1,1])
C0086035 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Allergic asthma
Item
subjects that do not have allergic asthma will be excluded.
boolean
C0155877 (UMLS CUI [1])
Emergency room visit | Upper Respiratory Infections
Item
subjects with er visits or upper respiratory infections within the last six weeks will be excluded.
boolean
C2114437 (UMLS CUI [1])
C0041912 (UMLS CUI [2])
Tobacco use
Item
subjects with tobacco use within the past year or > 10 pack year history of tobacco use will be excluded.
boolean
C0543414 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
serum IgE measurement
Item
subjects with serum ige levels of less than 30 or greater than 700 iu/ml will be excluded.
boolean
C2229760 (UMLS CUI [1])
oral steroid
Item
subjects that require oral steroid use will be excluded.
boolean
C0574135 (UMLS CUI [1])
Body weight | serum IgE measurement
Item
subjects who weigh < 30 kg or > 150 kg are excluded, and subjects with baseline ige levels greater than 300 may be excluded, depending on weight
boolean
C0005910 (UMLS CUI [1,1])
C2229760 (UMLS CUI [1,2])
Pregnancy | Breast feeding
Item
pregnant or nursing females will be excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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