ID

14343

Description

New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00394121

Link

https://clinicaltrials.gov/show/NCT00394121

Keywords

Versions (1)
  1. 4/11/16 4/11/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00394121

English

Eligibility Asthma NCT00394121

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00394121
Inclusion Criteria
Description

Inclusion Criteria

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

history of asthma

Data type

boolean

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

inhaled corticosteriod

Data type

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0748133
documented reversibility of 15% within 6 months of screening visit or at screening visit (15% increase from pre-fev-1 levels following albuterol inhalation).
Description

reversibility

Data type

boolean

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

asthma symptoms

Data type

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.
Description

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.

Data type

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.
Description

healthy

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

life-threatening asthma

Data type

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.
Description

history of systemic corticosteroid medication

Data type

boolean

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

omalizumab

Data type

boolean

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

leukotriene receptor antagonist

Data type

boolean

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

comorbidity

Data type

boolean

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

respiratory infection

Data type

boolean

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

pulmonary disease

Data type

boolean

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

hiv

Data type

boolean

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

smoking history

Data type

boolean

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

smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
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Similar models

Eligibility Asthma NCT00394121

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00394121
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
inhaled corticosteriod
Item
documented use of inhaled corticosteriod 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
C2065041 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2])
reversibility
Item
documented reversibility of 15% within 6 months of screening visit or at screening visit (15% increase from pre-fev-1 levels following albuterol inhalation).
boolean
C3548479 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
asthma symptoms
Item
symptoms of asthma during run-in.
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
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.
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])
history of systemic corticosteroid medication
Item
history of systemic corticosteroid medication within 3 months before screening visit.
boolean
C4039704 (UMLS CUI [1])
omalizumab
Item
history of omalizumab use within the 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 the past week.
boolean
C3542962 (UMLS CUI [1])
comorbidity
Item
current evidence of 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])
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])
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