ID

14522

Description

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

Link

https://clinicaltrials.gov/show/NCT00712205

Keywords

Versions (1)
  1. 4/19/16 4/19/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 19, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00712205

English

Eligibility Asthma NCT00712205

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00712205
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
20 outpatients of either sex,
Description

outpatients

Data type

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.
Description

age and persistent asthma

Data type

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.
Description

ics treatment

Data type

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:
Description

pre-bronchodilator fev1

Data type

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;
Description

post-bronchodilator fev1

Data type

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;
Description

methacholine challenge

Data type

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.
Description

pef variability

Data type

boolean

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

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.
Description

asthma exacerbation or respiratory tract infection or hospitalization for asthma

Data type

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.
Description

nighttime symptoms and beta-2 agonists

Data type

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®).
Description

potency greater than inhaled steroid

Data type

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
Description

copd and smoking history

Data type

boolean

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

Eligibility Asthma NCT00712205

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00712205
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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