ID

14138

Beskrivning

Trial to Evaluate the Effect of Statins on Asthma Control of Patients With Chronic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00126048

Länk

https://clinicaltrials.gov/show/NCT00126048

Nyckelord

Versioner (1)
  1. 2016-03-31 2016-03-31 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

31 mars 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00126048

Engelsk

Eligibility Asthma NCT00126048

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00126048
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of asthma: this will be established symptomatically by episodic wheezing, chest tightness and/or dyspnoea and objectively confirmed by methacholine airway hyperresponsiveness or by evidence of variable airflow obstruction with an increase in fev1 of > 12% following nebulised salbutamol (2.5mg) or diurnal peak flow variability of > 20% for 3 days in a week (with a minimum change of 60 l) during the run-in period of the study (bts).
Beskrivning

asthma diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C3526951
UMLS CUI [3]
C1303173
age range of 18-70 years
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
duration of asthma > 1 year and on stable medication for 4 weeks
Beskrivning

asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0040223
receiving regular inhaled steroid treatment (≤ 1000mcg beclomethasone equivalent daily) and no other medication for their asthma other than a short-acting bronchodilator.
Beskrivning

inhaled steroid treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0556393
UMLS CUI [2]
C0006280
symptomatic, defined as an asthma control questionnaire score of 1 (range 0-6) prior to randomisation or use of inhaled beta2-agonist on 5 or more days in the week before randomisation or fev1 reversibility >12% or diurnal peak flow variability of >20% during the run-in period of the study for at least 3 days of a week.
Beskrivning

symptomatic asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C2936789
UMLS CUI [3,1]
C0849974
UMLS CUI [3,2]
C0449261
stable asthma medication for at least 4 weeks prior to randomisation
Beskrivning

stable asthma medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0040223
written informed consent
Beskrivning

written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to demonstrate correct use of peak flow meter after instruction
Beskrivning

peak flow meter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0180915
current smokers or ex-smokers of < 1 year or ex-smokers who have smoked > 5 pack years.
Beskrivning

smoker

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0040223
patients with unstable asthma, defined as the presence of 1 or more of the following events in the month prior to randomisation: *emergency/'out of hours' visits of patients to the gp; *gp visit to patient at home; *a & e hospital attendance; *hospital admission.
Beskrivning

unstable asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C0553618
UMLS CUI [3]
C0184666
patients in whom cardiovascular risk requires statin therapy
Beskrivning

cardiovascular risk

Datatyp

boolean

Alias
UMLS CUI [1]
C0360714
UMLS CUI [2]
C0850624
any known sensitivity or adverse reaction to statin, or previous evidence of myopathy or myositis plus creatinine kinase and liver function tests > x2 upper limit of normal range.
Beskrivning

sensitivity or adverse reaction to statin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0360714
UMLS CUI [2]
C0026848
UMLS CUI [3]
C0201973
UMLS CUI [4]
C0232741
non-atopic asthma (specific ige skin test negative to common allergens) [skin test wheal </= 3mm over negative control saline]
Beskrivning

non atopic asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0340064
patients who show specific ige sensitivity or are skin test positive to grass pollen allergen will not be recruited from mid may to the end of july (grass allergen season in the united kingdom [uk]).
Beskrivning

ige sensitivity or are skin test positive to grass pollen allergen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0020846
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0440307
pregnancy/lactation. patients who require medications known to interact with statins, such as azole antifungal agents, erythromycin, clarithromycin, cyclosporine, gemfibrozil, verapamil and amiodarone.
Beskrivning

pregnancy or lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0360714
UMLS CUI [3,2]
C0687133
inability to fully comprehend the patient information sheet.
Beskrivning

inability to fully comprehend the patient information sheet.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Asthma NCT00126048

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00126048
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
asthma diagnosis
Item
diagnosis of asthma: this will be established symptomatically by episodic wheezing, chest tightness and/or dyspnoea and objectively confirmed by methacholine airway hyperresponsiveness or by evidence of variable airflow obstruction with an increase in fev1 of > 12% following nebulised salbutamol (2.5mg) or diurnal peak flow variability of > 20% for 3 days in a week (with a minimum change of 60 l) during the run-in period of the study (bts).
boolean
C0004096 (UMLS CUI [1])
C3526951 (UMLS CUI [2])
C1303173 (UMLS CUI [3])
age
Item
age range of 18-70 years
boolean
C0001779 (UMLS CUI [1])
asthma
Item
duration of asthma > 1 year and on stable medication for 4 weeks
boolean
C0004096 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
inhaled steroid treatment
Item
receiving regular inhaled steroid treatment (≤ 1000mcg beclomethasone equivalent daily) and no other medication for their asthma other than a short-acting bronchodilator.
boolean
C0001617 (UMLS CUI [1,1])
C0556393 (UMLS CUI [1,2])
C0006280 (UMLS CUI [2])
symptomatic asthma
Item
symptomatic, defined as an asthma control questionnaire score of 1 (range 0-6) prior to randomisation or use of inhaled beta2-agonist on 5 or more days in the week before randomisation or fev1 reversibility >12% or diurnal peak flow variability of >20% during the run-in period of the study for at least 3 days of a week.
boolean
C0004096 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
C0849974 (UMLS CUI [3,1])
C0449261 (UMLS CUI [3,2])
stable asthma medication
Item
stable asthma medication for at least 4 weeks prior to randomisation
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
peak flow meter
Item
inability to demonstrate correct use of peak flow meter after instruction
boolean
C1321605 (UMLS CUI [1,1])
C0180915 (UMLS CUI [1,2])
smoker
Item
current smokers or ex-smokers of < 1 year or ex-smokers who have smoked > 5 pack years.
boolean
C0543414 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
unstable asthma
Item
patients with unstable asthma, defined as the presence of 1 or more of the following events in the month prior to randomisation: *emergency/'out of hours' visits of patients to the gp; *gp visit to patient at home; *a & e hospital attendance; *hospital admission.
boolean
C0443343 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0553618 (UMLS CUI [2])
C0184666 (UMLS CUI [3])
cardiovascular risk
Item
patients in whom cardiovascular risk requires statin therapy
boolean
C0360714 (UMLS CUI [1])
C0850624 (UMLS CUI [2])
sensitivity or adverse reaction to statin
Item
any known sensitivity or adverse reaction to statin, or previous evidence of myopathy or myositis plus creatinine kinase and liver function tests > x2 upper limit of normal range.
boolean
C0020517 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
C0026848 (UMLS CUI [2])
C0201973 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
non atopic asthma
Item
non-atopic asthma (specific ige skin test negative to common allergens) [skin test wheal </= 3mm over negative control saline]
boolean
C0340064 (UMLS CUI [1])
ige sensitivity or are skin test positive to grass pollen allergen
Item
patients who show specific ige sensitivity or are skin test positive to grass pollen allergen will not be recruited from mid may to the end of july (grass allergen season in the united kingdom [uk]).
boolean
C0020517 (UMLS CUI [1,1])
C0020846 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0440307 (UMLS CUI [2,2])
pregnancy or lactation
Item
pregnancy/lactation. patients who require medications known to interact with statins, such as azole antifungal agents, erythromycin, clarithromycin, cyclosporine, gemfibrozil, verapamil and amiodarone.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0360714 (UMLS CUI [3,1])
C0687133 (UMLS CUI [3,2])
inability to fully comprehend the patient information sheet.
Item
inability to fully comprehend the patient information sheet.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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