ID

43542

Beschreibung

Effect of Dietary Supplements With Fish Oil on Mannitol-induced Airway Sensitivity & Inflammation in Persons With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00526357

Link

https://clinicaltrials.gov/show/NCT00526357

Stichworte

Versionen (2)
  1. 13.04.16 13.04.16 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

CC BY-NC 3.0

Hochgeladen am

20. September 2021

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00526357

Englisch

Eligibility Asthma NCT00526357

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00526357
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

age and contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0700589
stable, mild atopic asthma with forced expiratory volume in one second (fev1) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta2-agonists as required or for those on steroids, taking < 1000 mcg of inhaled corticosteroid per day.
Beschreibung

mild stable asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0741266
UMLS CUI [1,2]
C2945599
UMLS CUI [2]
C0748133
UMLS CUI [3]
C2936789
UMLS CUI [4]
C0586793
no recent or significant history of cigarette smoking (no smoking 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
signed written informed consent to participate in the study; ability to return to the clinic for repeated visits.
Beschreibung

written informed consent

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 four 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
UMLS CUI [3]
C0040223
subjects who take inhales steroids regularly must demonstrate reproducibility to inhaled mannitol (pd15<1.0 doubling doses) during a 2 week run-in period.
Beschreibung

reproducibility to inhaled mannitol

Datentyp

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2,1]
C0024730
UMLS CUI [2,2]
C0001559
UMLS CUI [3]
C0035149
a pd15 to the mannitol challenge < 315mg
Beschreibung

mannitol challenge

Datentyp

boolean

Alias
UMLS CUI [1]
C3161624
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular, metabolic such as including type ii diabetes or other body system disorder.
Beschreibung

comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
regular consumption of fish consisting more than 1 meal of fish per week or regular fish oil supplements during the trial and for at least 2 weeks prior to the first study visit.
Beschreibung

fish consumption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016163
UMLS CUI [1,2]
C0009830
subjects who have taken oral corticosteroids or a leukotriene receptor antagonist in 4 weeks prior to entry into the study.
Beschreibung

oral corticosteroids or a leukotriene receptor antagonist

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0442027
UMLS CUI [2]
C3542962
UMLS CUI [3]
C0040223
psychosis, alcoholism, active substance abuse, or any personality disorder, which would make compliance with this protocol problematic.
Beschreibung

comorbidity limiting compliance

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 lactation

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 study protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
subjects taking >1000 mcg of inhaled steroids daily in those subjects taking inhaled steroids.
Beschreibung

inhaled steroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C2348070
subjects requiring regular anti-histamines for allergies.
Beschreibung

antihistamines for allergies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019590
UMLS CUI [1,2]
C0020517
subjects who have allergy to fish or any other ingredient in the study products.
Beschreibung

allergy to fish or any other ingredient in the study products

Datentyp

boolean

Alias
UMLS CUI [1]
C0856904
UMLS CUI [2]
C0020517
subjects using anti-coagulants (warfarin, heparin)
Beschreibung

anticoagulants

Datentyp

boolean

Alias
UMLS CUI [1]
C0003280
subjects who have surgery planned over the course of the trial.
Beschreibung

surgery planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
subjects who use medications to lower ldl cholesterol levels
Beschreibung

medications to lower ldl cholesterol levels

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003277
UMLS CUI [1,2]
C0428474
subjects using non-steroidal anti-inflammatory medications (e.g., aspirin, ibuprofen)
Beschreibung

non-steroidal anti-inflammatory medications

Datentyp

boolean

Alias
UMLS CUI [1]
C0003211
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Ähnliche Modelle

Eligibility Asthma NCT00526357

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00526357
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age and contraception
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])
C0700589 (UMLS CUI [2])
mild stable asthma
Item
stable, mild atopic asthma with forced expiratory volume in one second (fev1) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta2-agonists as required or for those on steroids, taking < 1000 mcg of inhaled corticosteroid per day.
boolean
C0741266 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
C0586793 (UMLS CUI [4])
smoking history
Item
no recent or significant history of cigarette smoking (no smoking 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])
written informed consent
Item
signed written informed consent to participate in the study; ability to return to the clinic for repeated 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 four week period preceding entry into the screening phase of the study.
boolean
C0349790 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
reproducibility to inhaled mannitol
Item
subjects who take inhales steroids regularly must demonstrate reproducibility to inhaled mannitol (pd15<1.0 doubling doses) during a 2 week run-in period.
boolean
C2065041 (UMLS CUI [1])
C0024730 (UMLS CUI [2,1])
C0001559 (UMLS CUI [2,2])
C0035149 (UMLS CUI [3])
mannitol challenge
Item
a pd15 to the mannitol challenge < 315mg
boolean
C3161624 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular, metabolic such as including type ii diabetes or other body system disorder.
boolean
C0009488 (UMLS CUI [1])
fish consumption
Item
regular consumption of fish consisting more than 1 meal of fish per week or regular fish oil supplements during the trial and for at least 2 weeks prior to the first study visit.
boolean
C0016163 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
oral corticosteroids or a leukotriene receptor antagonist
Item
subjects who have taken oral corticosteroids or a leukotriene receptor antagonist in 4 weeks prior to entry into the study.
boolean
C0001617 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C3542962 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
comorbidity limiting compliance
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 lactation
Item
pregnant or nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
comorbidity limiting study protocol
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
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
inhaled steroids
Item
subjects taking >1000 mcg of inhaled steroids daily in those subjects taking inhaled steroids.
boolean
C2065041 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
antihistamines for allergies
Item
subjects requiring regular anti-histamines for allergies.
boolean
C0019590 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
allergy to fish or any other ingredient in the study products
Item
subjects who have allergy to fish or any other ingredient in the study products.
boolean
C0856904 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
anticoagulants
Item
subjects using anti-coagulants (warfarin, heparin)
boolean
C0003280 (UMLS CUI [1])
surgery planned
Item
subjects who have surgery planned over the course of the trial.
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
medications to lower ldl cholesterol levels
Item
subjects who use medications to lower ldl cholesterol levels
boolean
C0003277 (UMLS CUI [1,1])
C0428474 (UMLS CUI [1,2])
non-steroidal anti-inflammatory medications
Item
subjects using non-steroidal anti-inflammatory medications (e.g., aspirin, ibuprofen)
boolean
C0003211 (UMLS CUI [1])
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