ID

14341

Beskrivning

New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00393952

Länk

https://clinicaltrials.gov/show/NCT00393952

Nyckelord

Versioner (1)
  1. 2016-04-11 2016-04-11 -
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CC BY-NC 3.0

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11 april 2016

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00393952

Engelsk

Eligibility Asthma NCT00393952

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00393952
Criteria
Beskrivning

Criteria

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of asthma for at least 12 months.
Beskrivning

history of asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0040223
documented use of inhaled corticosteroid for at least 4 weeks prior to screening visit demonstrate fev-1 of 40-80% of predicted normal values at screening and baseline visit.
Beskrivning

inhaled corticosteroid

Datatyp

boolean

Alias
UMLS CUI [1]
C0586793
UMLS CUI [2]
C0040223
UMLS CUI [3]
C0748133
documented reversibility of 15% within 12 months of screening visit or at screening visit (15% increase from pre-fev-1 levels following albuterol inhalation or nebulized albuterol administration).
Beskrivning

reversibility of fev1

Datatyp

boolean

Alias
UMLS CUI [1]
C3548479
UMLS CUI [2,1]
C0748133
UMLS CUI [2,2]
C0001927
symptoms of asthma during run-in.
Beskrivning

asthma symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1457887
females of childbearing potential must have a negative urine pregnancy test at screening and baseline visits. females are eligible only if they are not pregnant or lactating, and are either sterile or using acceptable methods of contraception
Beskrivning

childbearing potential

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0430056
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
UMLS CUI [5]
C0700589
must otherwise be healthy.
Beskrivning

healthy

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
provide written informed consent. wishes of minors must be respected.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
life-threatening asthma within past year or during run-in period.
Beskrivning

life-threatening asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0040223
history of systemic corticosteroid medication within 3 months before screening visit.
Beskrivning

systemic corticosteroid

Datatyp

boolean

Alias
UMLS CUI [1]
C4039704
history of omalizumab use within past 6 months.
Beskrivning

omalizumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0966225
UMLS CUI [1,2]
C0040223
history of leukotriene receptor antagonist use, e.g. montelukast, within past week.
Beskrivning

leukotriene receptor antagonist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3542962
UMLS CUI [1,2]
C0040223
current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
upper or lower respiratory infection within 4 weeks prior to screening visit or during run-in period
Beskrivning

respiratory infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [copd], cystic fibrosis, bronchiectasis).
Beskrivning

pulmonary disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0024115
known human immunodeficiency virus (hiv)-positive status.
Beskrivning

hiv

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
smoking history equivalent to "10 pack years".
Beskrivning

smoking history

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
current smoking history within 12 months prior to screening visit.
Beskrivning

smoking history

Datatyp

boolean

Alias
UMLS CUI [1]
C1519384
current evidence or history of alcohol and/or substance abuse within 12 months prior to screening visit.
Beskrivning

history of alcohol and/or substance abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
patients who are confined in institution.
Beskrivning

confined in institution

Datatyp

boolean

Alias
UMLS CUI [1]
C0009847
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Similar models

Eligibility Asthma NCT00393952

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00393952
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
history of asthma
Item
history of asthma for at least 12 months.
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
inhaled corticosteroid
Item
documented use of inhaled corticosteroid for at least 4 weeks prior to screening visit demonstrate fev-1 of 40-80% of predicted normal values at screening and baseline visit.
boolean
C0586793 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0748133 (UMLS CUI [3])
reversibility of fev1
Item
documented reversibility of 15% within 12 months of screening visit or at screening visit (15% increase from pre-fev-1 levels following albuterol inhalation or nebulized albuterol administration).
boolean
C3548479 (UMLS CUI [1])
C0748133 (UMLS CUI [2,1])
C0001927 (UMLS CUI [2,2])
asthma symptoms
Item
symptoms of asthma during run-in.
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
childbearing potential
Item
females of childbearing potential must have a negative urine pregnancy test at screening and baseline visits. females are eligible only if they are not pregnant or lactating, and are either sterile or using acceptable methods of contraception
boolean
C3831118 (UMLS CUI [1])
C0430056 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
healthy
Item
must otherwise be healthy.
boolean
C1708335 (UMLS CUI [1])
informed consent
Item
provide written informed consent. wishes of minors must be respected.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
life-threatening asthma
Item
life-threatening asthma within past year or during run-in period.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
systemic corticosteroid
Item
history of systemic corticosteroid medication within 3 months before screening visit.
boolean
C4039704 (UMLS CUI [1])
omalizumab
Item
history of omalizumab use within past 6 months.
boolean
C0966225 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
leukotriene receptor antagonist
Item
history of leukotriene receptor antagonist use, e.g. montelukast, within past week.
boolean
C3542962 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
comorbidity
Item
current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
boolean
C0009488 (UMLS CUI [1])
respiratory infection
Item
upper or lower respiratory infection within 4 weeks prior to screening visit or during run-in period
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
pulmonary disease
Item
significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [copd], cystic fibrosis, bronchiectasis).
boolean
C0024115 (UMLS CUI [1])
hiv
Item
known human immunodeficiency virus (hiv)-positive status.
boolean
C0019682 (UMLS CUI [1])
smoking history
Item
smoking history equivalent to "10 pack years".
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
smoking history
Item
current smoking history within 12 months prior to screening visit.
boolean
C1519384 (UMLS CUI [1])
history of alcohol and/or substance abuse
Item
current evidence or history of alcohol and/or substance abuse within 12 months prior to screening visit.
boolean
C0038586 (UMLS CUI [1])
confined in institution
Item
patients who are confined in institution.
boolean
C0009847 (UMLS CUI [1])
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