ID

43023

Description

Assessment of Lung Inflammation in Patients With Atopic Asthma Using Positron Emission Tomography; ODM derived from: https://clinicaltrials.gov/show/NCT00001759

Link

https://clinicaltrials.gov/show/NCT00001759

Keywords

Versions (2)
  1. 1/10/16 1/10/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT00001759

English

Eligibility Asthma NCT00001759

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00001759
Criteria
Description

Criteria

negative pregnancy test within two days of the scan and willingness to adhere to reliable birth control until the completion of the protocol.
Description

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0032961
subjects must be able to give informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects in the negative control group must have no history of asthma or other lung disease.
Description

asthma or other lung disease

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0024115
control subjects must have negative prick skin tests to the allergens used.
Description

control subjects - allergy testing

Data type

boolean

Alias
UMLS CUI [1]
C0199747
UMLS CUI [2]
C0430561
asthmatic subjects must have asthma as defined in this study.
Description

Asthma by study definition

Data type

boolean

Alias
UMLS CUI [1]
C0004096
asthmatic subjects must have positive prick skin tests to one or more allergens used.
Description

asthma subjects - allergy testing

Data type

boolean

Alias
UMLS CUI [1]
C0199747
UMLS CUI [2]
C0430561
subjects must have access to a primary medical care provider outside of the nih.
Description

primary medical care provider

Data type

boolean

subjects must weigh less than 136 kg.
Description

body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
no breast feeding.
Description

breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
no smoking in the last 3 years, or greater than 6 months of smoking in the past ten years.
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
no antihistamines one week prior to the skin test on the first visit.
Description

antihistamines

Data type

boolean

Alias
UMLS CUI [1]
C0019590
no history of coronary artery disease.
Description

coronary artery disease

Data type

boolean

Alias
UMLS CUI [1]
C1956346
no evidence of lung disease other than asthma; no evidence of autoimmune or inflammatory disease which could affect lung function such as lupus erythematosus (except for the control subjects with wegener's granulomatosis).
Description

Lung, autoimmune and inflammatory disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0004364
UMLS CUI [3]
C1290884
no evidence of either acute (e.g., bacterial or viral pneumonia) or chronic (e.g., bronchiectasis) lung infection.
Description

lung infection

Data type

boolean

Alias
UMLS CUI [1]
C0876973
no diabetes, or history of glucose intolerance (e.g., gestational diabetes).
Description

diabetes, glucose intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0271650
no allergy to methacholine.
Description

allergy to methacholine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0600370
no beta-adrenergic blocking medication.
Description

beta-adrenergic antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0001645
control subjects must not have a history of asthma, atopic rhinitis or atopic dermatitis.
Description

control subjects - asthma, atopic rhinitis or atopic dermatitis

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0002103
UMLS CUI [3]
C0011615
control subjects must not have any response to inhaled methacholine with a fall in fev1 in excess of 20% to less than or equal to 25 mg/ml.
Description

control subjects - metacholine response, fev1

Data type

boolean

Alias
UMLS CUI [1]
C0600370
UMLS CUI [2]
C0748133
asthmatic subjects must not have chronic bronchitis or a diagnosis of chronic obstructive lung disease (copd).
Description

asthmatic subjects - chronic bronchitis or copd

Data type

boolean

Alias
UMLS CUI [1]
C0008677
UMLS CUI [2]
C0024117
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Similar models

Eligibility Asthma NCT00001759

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00001759
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
pregnancy test
Item
negative pregnancy test within two days of the scan and willingness to adhere to reliable birth control until the completion of the protocol.
boolean
C0032976 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
informed consent
Item
subjects must be able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
asthma or other lung disease
Item
subjects in the negative control group must have no history of asthma or other lung disease.
boolean
C0004096 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
control subjects - allergy testing
Item
control subjects must have negative prick skin tests to the allergens used.
boolean
C0199747 (UMLS CUI [1])
C0430561 (UMLS CUI [2])
Asthma by study definition
Item
asthmatic subjects must have asthma as defined in this study.
boolean
C0004096 (UMLS CUI [1])
asthma subjects - allergy testing
Item
asthmatic subjects must have positive prick skin tests to one or more allergens used.
boolean
C0199747 (UMLS CUI [1])
C0430561 (UMLS CUI [2])
primary medical care provider
Item
subjects must have access to a primary medical care provider outside of the nih.
boolean
body weight
Item
subjects must weigh less than 136 kg.
boolean
C0005910 (UMLS CUI [1])
breast feeding
Item
no breast feeding.
boolean
C0006147 (UMLS CUI [1])
smoking history
Item
no smoking in the last 3 years, or greater than 6 months of smoking in the past ten years.
boolean
C1519384 (UMLS CUI [1])
antihistamines
Item
no antihistamines one week prior to the skin test on the first visit.
boolean
C0019590 (UMLS CUI [1])
coronary artery disease
Item
no history of coronary artery disease.
boolean
C1956346 (UMLS CUI [1])
Lung, autoimmune and inflammatory disease
Item
no evidence of lung disease other than asthma; no evidence of autoimmune or inflammatory disease which could affect lung function such as lupus erythematosus (except for the control subjects with wegener's granulomatosis).
boolean
C0024115 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C1290884 (UMLS CUI [3])
lung infection
Item
no evidence of either acute (e.g., bacterial or viral pneumonia) or chronic (e.g., bronchiectasis) lung infection.
boolean
C0876973 (UMLS CUI [1])
diabetes, glucose intolerance
Item
no diabetes, or history of glucose intolerance (e.g., gestational diabetes).
boolean
C0011849 (UMLS CUI [1])
C0271650 (UMLS CUI [2])
allergy to methacholine
Item
no allergy to methacholine.
boolean
C0020517 (UMLS CUI [1,1])
C0600370 (UMLS CUI [1,2])
beta-adrenergic antagonists
Item
no beta-adrenergic blocking medication.
boolean
C0001645 (UMLS CUI [1])
control subjects - asthma, atopic rhinitis or atopic dermatitis
Item
control subjects must not have a history of asthma, atopic rhinitis or atopic dermatitis.
boolean
C0004096 (UMLS CUI [1])
C0002103 (UMLS CUI [2])
C0011615 (UMLS CUI [3])
control subjects - metacholine response, fev1
Item
control subjects must not have any response to inhaled methacholine with a fall in fev1 in excess of 20% to less than or equal to 25 mg/ml.
boolean
C0600370 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
asthmatic subjects - chronic bronchitis or copd
Item
asthmatic subjects must not have chronic bronchitis or a diagnosis of chronic obstructive lung disease (copd).
boolean
C0008677 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
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