ID

14144

Description

Bronchodilator Properties and Safety in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01951222

Link

https://clinicaltrials.gov/show/NCT01951222

Keywords

Versions (1)
  1. 3/31/16 3/31/16 -
Uploaded on

March 31, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT01951222

English

Eligibility Asthma NCT01951222

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01951222
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18 to 65 years-old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
18 ≤ bmi <30 kg/m².
Description

bmi

Data type

boolean

Alias
UMLS CUI [1]
C1305855
clinical history consistent asthma, in the judgement of the investigator.
Description

Asthma | Stable status

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
asthma controlled or partly controlled according to gina 2012 criteria:
Description

Persistent asthma, well controlled

Data type

boolean

Alias
UMLS CUI [1]
C3661869
asthma treated by ics and laba (fixed-dose combination or free combination) at stable dose for at least 3 months.
Description

Therapeutic procedure | Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C2065041
UMLS CUI [3]
C2936789
able to replace the usual ics and laba therapy by ics at the usual dose regimen and salbutamol as needed.
Description

Inhaled steroids | Salbutamol

Data type

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C0001927
able to stop salbutamol at least 6 hours before a study visit.
Description

Ability | stop medication | salbutamol

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0850893
UMLS CUI [1,3]
C0001927
able to perform at least 3 acceptable and reproducible fev1 and fvc measurements according to ers/ats 2005 recommendations.
Description

Ability | FEV1 | FVC

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0748133
UMLS CUI [2]
C1287681
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, copd, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
Description

Respiration Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0035204
UMLS CUI [2]
C0032285
UMLS CUI [3]
C0032326
UMLS CUI [4]
C0004144
UMLS CUI [5]
C0006267
UMLS CUI [6]
C0008677
UMLS CUI [7]
C0024117
UMLS CUI [8]
C0034067
UMLS CUI [9]
C2973725
UMLS CUI [10]
C0034069
upper or lower respiratory tract infection within 4 weeks.
Description

Upper Respiratory Infections | Lower respiratory tract infection

Data type

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
Description

Exacerbation of asthma | Adrenal Cortex Hormones | Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0019993
current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
Description

Current smoker | Former smoker | smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C0337671
UMLS CUI [3]
C2230126
intolerance to salbutamol.
Description

Intolerance | Salbutamol

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0001927
intolerance to tiotropium (or any other atropine-derived compound).
Description

Intolerance | tiotropium | Atropine Derivatives

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0213771
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0004260
intolerance to one of the ingredients of the study product
Description

Intolerance | Pharmaceutical Preparations | Clinical Research

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1550600
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0008972
severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, gastrointestinal obstruction, moderate to severe prostatic hypertrophy, bladder neck obstruction.
Description

Liver diseases | Moderate or Severe Renal Disease | Epilepsy | Angle Closure Glaucoma | Gastrointestinal obstruction | Prostatic Hypertrophy | Bladder neck obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C3829820
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0017605
UMLS CUI [5]
C0236124
UMLS CUI [6]
C1739363
UMLS CUI [7]
C0005694
any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
Description

Disease | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C2348568
clinically relevant physical examination abnormality.
Description

Physical Examination | Abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1704258
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Similar models

Eligibility Asthma NCT01951222

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01951222
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 18 to 65 years-old.
boolean
C0001779 (UMLS CUI [1])
bmi
Item
18 ≤ bmi <30 kg/m².
boolean
C1305855 (UMLS CUI [1])
Asthma | Stable status
Item
clinical history consistent asthma, in the judgement of the investigator.
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Persistent asthma, well controlled
Item
asthma controlled or partly controlled according to gina 2012 criteria:
boolean
C3661869 (UMLS CUI [1])
Therapeutic procedure | Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists
Item
asthma treated by ics and laba (fixed-dose combination or free combination) at stable dose for at least 3 months.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
Inhaled steroids | Salbutamol
Item
able to replace the usual ics and laba therapy by ics at the usual dose regimen and salbutamol as needed.
boolean
C2065041 (UMLS CUI [1])
C0001927 (UMLS CUI [2])
Ability | stop medication | salbutamol
Item
able to stop salbutamol at least 6 hours before a study visit.
boolean
C0085732 (UMLS CUI [1,1])
C0850893 (UMLS CUI [1,2])
C0001927 (UMLS CUI [1,3])
Ability | FEV1 | FVC
Item
able to perform at least 3 acceptable and reproducible fev1 and fvc measurements according to ers/ats 2005 recommendations.
boolean
C0085732 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
C1287681 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Respiration Disorders
Item
clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, copd, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
boolean
C0035204 (UMLS CUI [1])
C0032285 (UMLS CUI [2])
C0032326 (UMLS CUI [3])
C0004144 (UMLS CUI [4])
C0006267 (UMLS CUI [5])
C0008677 (UMLS CUI [6])
C0024117 (UMLS CUI [7])
C0034067 (UMLS CUI [8])
C2973725 (UMLS CUI [9])
C0034069 (UMLS CUI [10])
Upper Respiratory Infections | Lower respiratory tract infection
Item
upper or lower respiratory tract infection within 4 weeks.
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
Exacerbation of asthma | Adrenal Cortex Hormones | Hospitalization
Item
exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
boolean
C0349790 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
Current smoker | Former smoker | smoking cigarettes: ____ pack-years history
Item
current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
boolean
C3241966 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
C2230126 (UMLS CUI [3])
Intolerance | Salbutamol
Item
intolerance to salbutamol.
boolean
C1744706 (UMLS CUI [1,1])
C0001927 (UMLS CUI [1,2])
Intolerance | tiotropium | Atropine Derivatives
Item
intolerance to tiotropium (or any other atropine-derived compound).
boolean
C1744706 (UMLS CUI [1,1])
C0213771 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0004260 (UMLS CUI [2,2])
Intolerance | Pharmaceutical Preparations | Clinical Research
Item
intolerance to one of the ingredients of the study product
boolean
C1744706 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
Liver diseases | Moderate or Severe Renal Disease | Epilepsy | Angle Closure Glaucoma | Gastrointestinal obstruction | Prostatic Hypertrophy | Bladder neck obstruction
Item
severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, gastrointestinal obstruction, moderate to severe prostatic hypertrophy, bladder neck obstruction.
boolean
C0023895 (UMLS CUI [1])
C3829820 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0017605 (UMLS CUI [4])
C0236124 (UMLS CUI [5])
C1739363 (UMLS CUI [6])
C0005694 (UMLS CUI [7])
Disease | Study Subject Participation Status
Item
any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
boolean
C0012634 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Physical Examination | Abnormality
Item
clinically relevant physical examination abnormality.
boolean
C0031809 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
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