ID

13561

Description

A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241 AM3); ODM derived from: https://clinicaltrials.gov/show/NCT01471340

Link

https://clinicaltrials.gov/show/NCT01471340

Keywords

Versions (1)
  1. 2/15/16 2/15/16 -
Uploaded on

February 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT01471340

English

Eligibility Asthma NCT01471340

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01471340
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
persistent asthma for at least 1-year
Description

persistent asthma

Data type

boolean

Alias
UMLS CUI [1]
C3266628
must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ics) with or without a long-acting beta agonist (laba) or other adjunctive asthma therapy or be using a leukotriene receptor antagonist (ltra), xanthine or short acting beta agonist (saba) as a monotherapy.
Description

asthma therapy; corticosteroid

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C3536709
must be able to discontinue current asthma medication
Description

medication asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0004096
must have a history of at least one asthma exacerbation in previous 4 to 52 weeks
Description

asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0349790
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unstable asthma
Description

Unstable status asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0004096
taking high dose ics with or without other adjunctive therapy who have an asthma control questionnaire 6 (acq6) total score ≥ 1.5
Description

corticosteroid; Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0677850
taking ltra, xanthine or saba monotherapy with an acq-6 total score < 1.5 (controlled)
Description

xanthine

Data type

boolean

Alias
UMLS CUI [1]
C3541955
chronic obstructive pulmonary disease (copd), cystic fibrosis (cf), or other significant, non-asthmatic, lung disease
Description

comorbidity Lung diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0024115
clinically significant abnormality, illness or disorder of any body or organ system
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
significant underlying cardiovascular condition which may contraindicate use of a beta-agonist.
Description

comorbidity Cardiovascular Diseases; medication contraindication beta agonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0007222
UMLS CUI [2,1]
C3699431
UMLS CUI [2,2]
C0001644
history of smoking greater than 10-pack years
Description

smoking status

Data type

boolean

Alias
UMLS CUI [1]
C1519386
had an asthma exacerbation within 4 weeks of the baseline visit
Description

asthma exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0349790
had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the randomization visit
Description

asthma exacerbation hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0019993
known or suspected hypersensitivity or intolerance to corticosteroids, beta-2 agonists, or any of the (inactive ingredients) excipients present in the medications used in this study
Description

hypersensitivity corticosteroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001617
require the use of chronic systemic steroids, omalizumab, or other monoclonal or polyclonal antibodies
Description

antibodies; systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C0003241
UMLS CUI [2]
C2825233
requires the use of beta-blockers
Description

beta-blockers

Data type

boolean

Alias
UMLS CUI [1]
C0304516
history of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring noninvasive ventilatory support
Description

severe asthma; intubation; hypercapnia

Data type

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2]
C0021925
UMLS CUI [3]
C0020440
lactating, pregnant, or plans to become pregnant during the course of the trial
Description

pregnancy; lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Asthma NCT01471340

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01471340
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
persistent asthma
Item
persistent asthma for at least 1-year
boolean
C3266628 (UMLS CUI [1])
asthma therapy; corticosteroid
Item
must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ics) with or without a long-acting beta agonist (laba) or other adjunctive asthma therapy or be using a leukotriene receptor antagonist (ltra), xanthine or short acting beta agonist (saba) as a monotherapy.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C3536709 (UMLS CUI [2])
medication asthma
Item
must be able to discontinue current asthma medication
boolean
C0013227 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
asthma exacerbation
Item
must have a history of at least one asthma exacerbation in previous 4 to 52 weeks
boolean
C0349790 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Unstable status asthma
Item
unstable asthma
boolean
C0443343 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
corticosteroid; Adjuvant therapy
Item
taking high dose ics with or without other adjunctive therapy who have an asthma control questionnaire 6 (acq6) total score ≥ 1.5
boolean
C0001617 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
xanthine
Item
taking ltra, xanthine or saba monotherapy with an acq-6 total score < 1.5 (controlled)
boolean
C3541955 (UMLS CUI [1])
comorbidity Lung diseases
Item
chronic obstructive pulmonary disease (copd), cystic fibrosis (cf), or other significant, non-asthmatic, lung disease
boolean
C0009488 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
comorbidity
Item
clinically significant abnormality, illness or disorder of any body or organ system
boolean
C0009488 (UMLS CUI [1])
comorbidity Cardiovascular Diseases; medication contraindication beta agonist
Item
significant underlying cardiovascular condition which may contraindicate use of a beta-agonist.
boolean
C0009488 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
C3699431 (UMLS CUI [2,1])
C0001644 (UMLS CUI [2,2])
smoking status
Item
history of smoking greater than 10-pack years
boolean
C1519386 (UMLS CUI [1])
asthma exacerbation
Item
had an asthma exacerbation within 4 weeks of the baseline visit
boolean
C0349790 (UMLS CUI [1])
asthma exacerbation hospitalization
Item
had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the randomization visit
boolean
C0349790 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
hypersensitivity corticosteroids
Item
known or suspected hypersensitivity or intolerance to corticosteroids, beta-2 agonists, or any of the (inactive ingredients) excipients present in the medications used in this study
boolean
C0020517 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
antibodies; systemic steroids
Item
require the use of chronic systemic steroids, omalizumab, or other monoclonal or polyclonal antibodies
boolean
C0003241 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
beta-blockers
Item
requires the use of beta-blockers
boolean
C0304516 (UMLS CUI [1])
severe asthma; intubation; hypercapnia
Item
history of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring noninvasive ventilatory support
boolean
C0581126 (UMLS CUI [1])
C0021925 (UMLS CUI [2])
C0020440 (UMLS CUI [3])
pregnancy; lactating
Item
lactating, pregnant, or plans to become pregnant during the course of the trial
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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