ID

14491

Description

A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00649025

Link

https://clinicaltrials.gov/show/NCT00649025

Keywords

Versions (1)
  1. 4/18/16 4/18/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 18, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00649025

English

Eligibility Asthma NCT00649025

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00649025
Criteria
Description

Criteria

≥ age 12 years at the screening visit.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
history of asthma for 12 months prior to the screening visit.
Description

history of asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
documented use of an inhaled corticosteroid for at least 4 weeks prior to the screening visit.
Description

inhaled corticosteroid

Data type

boolean

Alias
UMLS CUI [1,1]
C0586793
UMLS CUI [1,2]
C0040223
steroid-requiring patient
Description

steroid requiring

Data type

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C1514873
patients must demonstrate (1) an fev1 of 40% to 80% (inclusive) of predicted normal values at both the screening and baseline visits and (2) documented reversibility within 12 months of the screening visit, defined as a ≥ 15%
Description

fev1 and fev1 reversibility

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2,1]
C0748133
UMLS CUI [2,2]
C0449261
main exclusion criteria:
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
life-threatening asthma within the past year or during the 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 (oral or injectable) corticosteroid medication within 3 months before the screening visit.
Description

systemic steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0040223
an upper or lower respiratory infection within 4 weeks prior to the screening visit or during the run-in period.
Description

respiratory infection

Data type

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).
Description

pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
a smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
Description

smoking history

Data type

boolean

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

current smoking history

Data type

boolean

Alias
UMLS CUI [1]
C1519384
previous exposure to flutiform
Description

previous exposure to flutiform

Data type

boolean

Alias
UMLS CUI [1,1]
C3849509
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332157
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Similar models

Eligibility Asthma NCT00649025

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00649025
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
age
Item
≥ age 12 years at the screening visit.
boolean
C0001779 (UMLS CUI [1])
history of asthma
Item
history of asthma for 12 months prior to the screening visit.
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
inhaled corticosteroid
Item
documented use of an inhaled corticosteroid for at least 4 weeks prior to the screening visit.
boolean
C0586793 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
steroid requiring
Item
steroid-requiring patient
boolean
C0038317 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
fev1 and fev1 reversibility
Item
patients must demonstrate (1) an fev1 of 40% to 80% (inclusive) of predicted normal values at both the screening and baseline visits and (2) documented reversibility within 12 months of the screening visit, defined as a ≥ 15%
boolean
C0748133 (UMLS CUI [1])
C0748133 (UMLS CUI [2,1])
C0449261 (UMLS CUI [2,2])
exclusion criteria
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
life-threatening asthma
Item
life-threatening asthma within the past year or during the run-in period.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
systemic steroids
Item
history of systemic (oral or injectable) corticosteroid medication within 3 months before the screening visit.
boolean
C2825233 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
respiratory infection
Item
an upper or lower respiratory infection within 4 weeks prior to the screening visit or during the 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])
smoking history
Item
a smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
boolean
C1519384 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
current smoking history
Item
current smoking history within 12 months prior to the screening visit.
boolean
C1519384 (UMLS CUI [1])
previous exposure to flutiform
Item
previous exposure to flutiform
boolean
C3849509 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
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