ID

14516

Beschreibung

p38 Mitogen−Activated Protein Kinase (MAPK) and Steroid Insensitivity in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00676572

Link

https://clinicaltrials.gov/show/NCT00676572

Stichworte

Versionen (1)
  1. 19.04.16 19.04.16 -
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CC BY-NC 3.0

Hochgeladen am

19. April 2016

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Eligibility Asthma NCT00676572

Englisch

Eligibility Asthma NCT00676572

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00676572
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-60
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
physician diagnosis of asthma
Beschreibung

asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
non-severe asthmatic subjects:
Beschreibung

asthma non-severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
mild to moderately severe asthma.
Beschreibung

mild to moderately severe asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
the groups will be defined as follows, according to their need for treatments (as established in the asthma management gina or bts guidelines):
Beschreibung

asthma treatment groups

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040808
1. mild: intermittent symptoms and need for reliever bronchodilator less than once a day
Beschreibung

mild intermittent asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C1960045
UMLS CUI [2]
C0006280
2. moderate asthma: well-controlled asthma with minimal symptoms while on inhaled corticosteroid therapy not exceeding 2,000 μg beclomethasone equivalent.
Beschreibung

moderate asthma with inhaled steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C1960047
UMLS CUI [2]
C0586793
severe asthmatic subjects:
Beschreibung

severe asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0581126
will have at least 1 major and 2 minor criteria (as below) major characteristics (at least one of the following criteria)
Beschreibung

asthma criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0242801
treatment with continuous or near continuous (>50% of year) oral corticosteroids
Beschreibung

oral corticosteroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0442027
requirement for treatment with high dose inhaled corticosteroids (ics) minor characteristics (at least 2 out of the following)
Beschreibung

high dose inhaled corticosteroids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0444956
1. requirement for daily treatment with a controller medication in addition to ics e.g. laba, theophylline, leukotriene antagonist
Beschreibung

requirement for daily controller medication

Datentyp

boolean

2. asthma symptoms requiring saba on a daily or near daily basis
Beschreibung

short-acting beta-2 agonist

Datentyp

boolean

Alias
UMLS CUI [1]
C1373132
3. persistent airways obstruction (fev1 <80% predicted, diurnal pef variation >20%)
Beschreibung

fev1, pef variability

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2,1]
C0030735
UMLS CUI [2,2]
C2827666
4. one or more emergency care visits for asthma per year
Beschreibung

emergency care visits for asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0583237
UMLS CUI [1,2]
C0004096
5. 3 or more steroid "bursts" per year
Beschreibung

steroid burst

Datentyp

boolean

Alias
UMLS CUI [1]
C0744425
6. prompt deterioration with ≤ 25% reduction in oral or ics
Beschreibung

deterioration with reduction in oral or ics

Datentyp

boolean

Alias
UMLS CUI [1]
C0868945
UMLS CUI [2,1]
C0441610
UMLS CUI [2,2]
C0149783
7. near fatal asthma event in the past
Beschreibung

near fatal asthma event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C1302234
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
current smokers, or less than 3 years since quitting smoking (< 5 pack/years)
Beschreibung

smoking history

Datentyp

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C1277691
less than 4 weeks from an exacerbation
Beschreibung

asthma exacerbation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0040223
on steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin
Beschreibung

steroid-sparing agent or immunosuppressant

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
concomitant anti-ige therapy
Beschreibung

anti-ige therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0051978
on anti-platelet or anti-coagulant drugs
Beschreibung

anti-platelet or anti-coagulant drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0085826
UMLS CUI [2]
C0003280
low platelet count
Beschreibung

platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
pregnancy or breast-feeding
Beschreibung

pregnancy or breast-feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
intubation for asthma within 6 months of entry into this study (if undergoing bronchoscopy)
Beschreibung

intubation for asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021925
UMLS CUI [1,2]
C0004096
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Ähnliche Modelle

Eligibility Asthma NCT00676572

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00676572
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age 18-60
boolean
C0001779 (UMLS CUI [1])
asthma
Item
physician diagnosis of asthma
boolean
C0004096 (UMLS CUI [1])
asthma non-severe
Item
non-severe asthmatic subjects:
boolean
C0004096 (UMLS CUI [1])
mild to moderately severe asthma
Item
mild to moderately severe asthma.
boolean
C0004096 (UMLS CUI [1])
asthma treatment groups
Item
the groups will be defined as follows, according to their need for treatments (as established in the asthma management gina or bts guidelines):
boolean
C0004096 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
mild intermittent asthma
Item
1. mild: intermittent symptoms and need for reliever bronchodilator less than once a day
boolean
C1960045 (UMLS CUI [1])
C0006280 (UMLS CUI [2])
moderate asthma with inhaled steroids
Item
2. moderate asthma: well-controlled asthma with minimal symptoms while on inhaled corticosteroid therapy not exceeding 2,000 μg beclomethasone equivalent.
boolean
C1960047 (UMLS CUI [1])
C0586793 (UMLS CUI [2])
severe asthma
Item
severe asthmatic subjects:
boolean
C0581126 (UMLS CUI [1])
asthma criteria
Item
will have at least 1 major and 2 minor criteria (as below) major characteristics (at least one of the following criteria)
boolean
C0242801 (UMLS CUI [1])
oral corticosteroids
Item
treatment with continuous or near continuous (>50% of year) oral corticosteroids
boolean
C0001617 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
high dose inhaled corticosteroids
Item
requirement for treatment with high dose inhaled corticosteroids (ics) minor characteristics (at least 2 out of the following)
boolean
C2065041 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
requirement for daily controller medication
Item
1. requirement for daily treatment with a controller medication in addition to ics e.g. laba, theophylline, leukotriene antagonist
boolean
short-acting beta-2 agonist
Item
2. asthma symptoms requiring saba on a daily or near daily basis
boolean
C1373132 (UMLS CUI [1])
fev1, pef variability
Item
3. persistent airways obstruction (fev1 <80% predicted, diurnal pef variation >20%)
boolean
C0748133 (UMLS CUI [1])
C0030735 (UMLS CUI [2,1])
C2827666 (UMLS CUI [2,2])
emergency care visits for asthma
Item
4. one or more emergency care visits for asthma per year
boolean
C0583237 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
steroid burst
Item
5. 3 or more steroid "bursts" per year
boolean
C0744425 (UMLS CUI [1])
deterioration with reduction in oral or ics
Item
6. prompt deterioration with ≤ 25% reduction in oral or ics
boolean
C0868945 (UMLS CUI [1])
C0441610 (UMLS CUI [2,1])
C0149783 (UMLS CUI [2,2])
near fatal asthma event
Item
7. near fatal asthma event in the past
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
smoking history
Item
current smokers, or less than 3 years since quitting smoking (< 5 pack/years)
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
asthma exacerbation
Item
less than 4 weeks from an exacerbation
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
steroid-sparing agent or immunosuppressant
Item
on steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin
boolean
C0021081 (UMLS CUI [1])
anti-ige therapy
Item
concomitant anti-ige therapy
boolean
C0051978 (UMLS CUI [1])
anti-platelet or anti-coagulant drugs
Item
on anti-platelet or anti-coagulant drugs
boolean
C0085826 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
platelet count
Item
low platelet count
boolean
C0032181 (UMLS CUI [1])
pregnancy or breast-feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
intubation for asthma
Item
intubation for asthma within 6 months of entry into this study (if undergoing bronchoscopy)
boolean
C0021925 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
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