ID

14522

Beskrivning

Vitamin D for the Treatment of Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00712205

Länk

https://clinicaltrials.gov/show/NCT00712205

Nyckelord

  1. 2016-04-19 2016-04-19 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

19 april 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Asthma NCT00712205

Eligibility Asthma NCT00712205

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00712205
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
20 outpatients of either sex,
Beskrivning

outpatients

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
ages ≥18 years, with a history of persistent asthma as defined by the american thoracic society (ats) will be eligible for entry into the study.
Beskrivning

age and persistent asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3266628
additionally, patients must have been previously treated with ics for at least 4 weeks at a stable dose equivalent to ≥400 ug/day beclomethasone dipropionate.
Beskrivning

ics treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3248292
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0004906
patients will be required to have a forced expiratory volume in 1 s (fev1) between 40-85% of predicted normal before the use of an inhaled bronchodilator and to demonstrate at least one of the following:
Beskrivning

pre-bronchodilator fev1

Datatyp

boolean

Alias
UMLS CUI [1]
C3172227
an improvement in fev1 ≥ 12% and ≥ 200 ml within 15-30 min after inhalation of salbutamol 200-400 ug;
Beskrivning

post-bronchodilator fev1

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
UMLS CUI [1,3]
C0001927
airway hyperresponsiveness to methacholine causing a 20% decline in fev1 (pc20 fev1) at a concentration of < 16 mg/ml;
Beskrivning

methacholine challenge

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430567
UMLS CUI [1,2]
C0748133
diurnal peak expiratory flow (pef) variability of ≥ 15% during at least 3 of 7 days before randomization.
Beskrivning

pef variability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030735
UMLS CUI [1,2]
C2827666
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with either an exacerbation of asthma or respiratory tract infection within 6 weeks or admission to a hospital for asthma within 6 weeks before the study will be excluded.
Beskrivning

asthma exacerbation or respiratory tract infection or hospitalization for asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0458827
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0004096
UMLS CUI [4]
C0040223
also patients will not be eligible if they had > 3 nights with awakenings due to asthma that required treatment with short-acting betamimetics or had 3 days when they required > or = 12 puffs/d short-acting betamimetics during the 7days before the randomization visits.
Beskrivning

nighttime symptoms and beta-2 agonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1273489
UMLS CUI [1,2]
C0860510
UMLS CUI [2]
C1373132
patients will also excluded if they use medications greater potency than inhaled steroid, e.g.not leukotriene inhibitors or anti-ige (xolair®).
Beskrivning

potency greater than inhaled steroid

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0678792
patients with chronic obstructive pulmonary disease and current or former smokers of >10 pack-years
Beskrivning

copd and smoking history

Datatyp

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C1519384
UMLS CUI [3]
C1277691

Similar models

Eligibility Asthma NCT00712205

  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00712205
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
outpatients
Item
20 outpatients of either sex,
boolean
C0029921 (UMLS CUI [1])
age and persistent asthma
Item
ages ≥18 years, with a history of persistent asthma as defined by the american thoracic society (ats) will be eligible for entry into the study.
boolean
C0001779 (UMLS CUI [1])
C3266628 (UMLS CUI [2])
ics treatment
Item
additionally, patients must have been previously treated with ics for at least 4 weeks at a stable dose equivalent to ≥400 ug/day beclomethasone dipropionate.
boolean
C3248292 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0004906 (UMLS CUI [2])
pre-bronchodilator fev1
Item
patients will be required to have a forced expiratory volume in 1 s (fev1) between 40-85% of predicted normal before the use of an inhaled bronchodilator and to demonstrate at least one of the following:
boolean
C3172227 (UMLS CUI [1])
post-bronchodilator fev1
Item
an improvement in fev1 ≥ 12% and ≥ 200 ml within 15-30 min after inhalation of salbutamol 200-400 ug;
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
C0001927 (UMLS CUI [1,3])
methacholine challenge
Item
airway hyperresponsiveness to methacholine causing a 20% decline in fev1 (pc20 fev1) at a concentration of < 16 mg/ml;
boolean
C0430567 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
pef variability
Item
diurnal peak expiratory flow (pef) variability of ≥ 15% during at least 3 of 7 days before randomization.
boolean
C0030735 (UMLS CUI [1,1])
C2827666 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
asthma exacerbation or respiratory tract infection or hospitalization for asthma
Item
patients with either an exacerbation of asthma or respiratory tract infection within 6 weeks or admission to a hospital for asthma within 6 weeks before the study will be excluded.
boolean
C0349790 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0458827 (UMLS CUI [2,2])
C0019993 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C0040223 (UMLS CUI [4])
nighttime symptoms and beta-2 agonists
Item
also patients will not be eligible if they had > 3 nights with awakenings due to asthma that required treatment with short-acting betamimetics or had 3 days when they required > or = 12 puffs/d short-acting betamimetics during the 7days before the randomization visits.
boolean
C1273489 (UMLS CUI [1,1])
C0860510 (UMLS CUI [1,2])
C1373132 (UMLS CUI [2])
potency greater than inhaled steroid
Item
patients will also excluded if they use medications greater potency than inhaled steroid, e.g.not leukotriene inhibitors or anti-ige (xolair®).
boolean
C2065041 (UMLS CUI [1,1])
C0678792 (UMLS CUI [1,2])
copd and smoking history
Item
patients with chronic obstructive pulmonary disease and current or former smokers of >10 pack-years
boolean
C0024117 (UMLS CUI [1])
C1519384 (UMLS CUI [2])
C1277691 (UMLS CUI [3])

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