ID

44603

Beschreibung

Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00320034

Link

https://clinicaltrials.gov/show/NCT00320034

Stichworte

Versionen (2)
  1. 07.04.16 07.04.16 -
  2. 27.09.21 27.09.21 -
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CC BY-NC 3.0

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27. September 2021

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Eligibility Asthma NCT00320034

Englisch

Eligibility Asthma NCT00320034

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00320034
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55.
Beschreibung

male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55.

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0700589
stable, mild atopic asthma with forced expiratory volume in one second (fev1.0) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta-agonists as needed.
Beschreibung

stable, mild atopic asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0748133
UMLS CUI [3]
C2936789
no recent or significant history of cigarette smoking (no cigarettes within six months prior to entry into the study; less than 10 pack-years cumulative history of cigarette smoking).
Beschreibung

smoking history

Datentyp

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
peak decrease in fev1 in both early (0-2 hour) and late (3-7 hour) allergen-provoked response of > 15% compared with the baseline (pre-allergen challenge) spirometric determination.
Beschreibung

fev1

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
signed written informed consent to participate in the protocol; ability to return to the outpatient clinic for repeated clinic visits.
Beschreibung

written informed consent and compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
no history of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a six week period preceding entry into the screening phase of the study.
Beschreibung

asthma exacerbation or acute intercurrent respiratory illness

Datentyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0035204
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular or other body system disorder.
Beschreibung

comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
history of an acute exacerbation, or of a respiratory tract infection at any time during the past 6 weeks.
Beschreibung

asthma exacerbation or respiratory tract infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0458827
baseline ast or alt (indicators of liver damage) greater than twice the upper limit of the normal range for the local laboratory.
Beschreibung

ast, alt

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
history of allergy or hypersensitivity to short-acting beta-agonists.
Beschreibung

hypersensitivity to short-acting beta-agonists

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001644
inability to discontinue asthma medications for the duration of the study or receipt of oral or inhaled corticosteroids or leukotriene receptor antagonist in the three weeks prior to entry into the screening phase of the study.
Beschreibung

compliance or receipt of steroids or leukotriene receptor antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0595726
recent (within the past 2 months) or planned (within the study period) lung volume reduction surgery.
Beschreibung

lung volume reduction surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0524689
psychosis, alcoholism, active substance abuse, or any personality disorder which would make compliance with this protocol problematic.
Beschreibung

comorbidity limiting study protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
pregnant or nursing females.
Beschreibung

pregnancy or breast feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any other medical or social condition which, in the opinion of the investigator, could confound the interpretation of the data derived from this study.
Beschreibung

comorbidity limiting interpretation of the data

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Ähnliche Modelle

Eligibility Asthma NCT00320034

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00320034
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55.
Item
male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55.
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
stable, mild atopic asthma
Item
stable, mild atopic asthma with forced expiratory volume in one second (fev1.0) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta-agonists as needed.
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
smoking history
Item
no recent or significant history of cigarette smoking (no cigarettes within six months prior to entry into the study; less than 10 pack-years cumulative history of cigarette smoking).
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
fev1
Item
peak decrease in fev1 in both early (0-2 hour) and late (3-7 hour) allergen-provoked response of > 15% compared with the baseline (pre-allergen challenge) spirometric determination.
boolean
C0748133 (UMLS CUI [1])
written informed consent and compliance
Item
signed written informed consent to participate in the protocol; ability to return to the outpatient clinic for repeated clinic visits.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
asthma exacerbation or acute intercurrent respiratory illness
Item
no history of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a six week period preceding entry into the screening phase of the study.
boolean
C0349790 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular or other body system disorder.
boolean
C0009488 (UMLS CUI [1])
asthma exacerbation or respiratory tract infection
Item
history of an acute exacerbation, or of a respiratory tract infection at any time during the past 6 weeks.
boolean
C0349790 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0458827 (UMLS CUI [2,2])
ast, alt
Item
baseline ast or alt (indicators of liver damage) greater than twice the upper limit of the normal range for the local laboratory.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
hypersensitivity to short-acting beta-agonists
Item
history of allergy or hypersensitivity to short-acting beta-agonists.
boolean
C0020517 (UMLS CUI [1,1])
C0001644 (UMLS CUI [1,2])
compliance or receipt of steroids or leukotriene receptor antagonists
Item
inability to discontinue asthma medications for the duration of the study or receipt of oral or inhaled corticosteroids or leukotriene receptor antagonist in the three weeks prior to entry into the screening phase of the study.
boolean
C1321605 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0595726 (UMLS CUI [3])
lung volume reduction surgery
Item
recent (within the past 2 months) or planned (within the study period) lung volume reduction surgery.
boolean
C0524689 (UMLS CUI [1])
comorbidity limiting study protocol
Item
psychosis, alcoholism, active substance abuse, or any personality disorder which would make compliance with this protocol problematic.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
pregnancy or breast feeding
Item
pregnant or nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
comorbidity limiting interpretation of the data
Item
any other medical or social condition which, in the opinion of the investigator, could confound the interpretation of the data derived from this study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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