ID

14448

Description

Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids (ICS) With or Without Other Controllers; ODM derived from: https://clinicaltrials.gov/show/NCT02449473

Link

https://clinicaltrials.gov/show/NCT02449473

Keywords

Versions (1)
  1. 4/15/16 4/15/16 -
Uploaded on

April 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT02449473

English

Eligibility Asthma NCT02449473

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02449473
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 to 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
Description

Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
3. documented treatment with an asthma controller regimen requiring treatment with ics (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1)
Description

Asthma Treatment Protocols | inhaled steroids | Fluticasone propionate Dry Powder Inhaler

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040808
UMLS CUI [2]
C2065041
UMLS CUI [3,1]
C0117996
UMLS CUI [3,2]
C1967611
4. additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1.
Description

Additional medication therapy required Asthma control

Data type

boolean

Alias
UMLS CUI [1,1]
C3494715
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0243148
5. at enrolment (v1) the subject must have a predicted normal value (pnv) for the morning pre-bronchodilator (bd) fev1>50% and more than 1l.
Description

pre bronchodilator FEV1 Morning

Data type

boolean

Alias
UMLS CUI [1,1]
C2599602
UMLS CUI [1,2]
C0748133
UMLS CUI [1,3]
C0332170
6. post-bd reversibility in fev1 of ≥12% and ≥200 ml at enrolment (v1).
Description

post bronchodilator Forced Expiratory Volume in 1 Second Reversibility

Data type

boolean

Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C3830088
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of interstitial lung disease, chronic obstructive pulmonary disease (copd), or other clinically significant lung disease other than asthma.
Description

Lung Diseases, Interstitial | Chronic Obstructive Airway Disease | Other Lung diseases | Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C0024117
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C0024115
UMLS CUI [4]
C0004096
2. history of anaphylaxis following any biologic therapy.
Description

Anaphylaxis Following Biological Response Modifier Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0005527
3. hepatitis b, c or hiv
Description

Hepatitis B | Hepatitis C | HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019682
4. pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. history of cancer
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
6. current tobacco smoking or a history of tobacco smoking for ≥10 pack-years.
Description

Current Smoker | Smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C2230126
7. previous receipt of tralokinumab
Description

Received tralokinumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1514756
UMLS CUI [1,2]
C3658667
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Similar models

Eligibility Asthma NCT02449473

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02449473
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
Asthma
Item
2. documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
boolean
C0004096 (UMLS CUI [1])
Asthma Treatment Protocols | inhaled steroids | Fluticasone propionate Dry Powder Inhaler
Item
3. documented treatment with an asthma controller regimen requiring treatment with ics (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1)
boolean
C0004096 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3,1])
C1967611 (UMLS CUI [3,2])
Additional medication therapy required Asthma control
Item
4. additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1.
boolean
C3494715 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,3])
pre bronchodilator FEV1 Morning
Item
5. at enrolment (v1) the subject must have a predicted normal value (pnv) for the morning pre-bronchodilator (bd) fev1>50% and more than 1l.
boolean
C2599602 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
post bronchodilator Forced Expiratory Volume in 1 Second Reversibility
Item
6. post-bd reversibility in fev1 of ≥12% and ≥200 ml at enrolment (v1).
boolean
C2599594 (UMLS CUI [1,1])
C3830088 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Lung Diseases, Interstitial | Chronic Obstructive Airway Disease | Other Lung diseases | Asthma
Item
1. history of interstitial lung disease, chronic obstructive pulmonary disease (copd), or other clinically significant lung disease other than asthma.
boolean
C0206062 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C0205394 (UMLS CUI [3,1])
C0024115 (UMLS CUI [3,2])
C0004096 (UMLS CUI [4])
Anaphylaxis Following Biological Response Modifier Therapy
Item
2. history of anaphylaxis following any biologic therapy.
boolean
C0002792 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0005527 (UMLS CUI [1,3])
Hepatitis B | Hepatitis C | HIV
Item
3. hepatitis b, c or hiv
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
4. pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms
Item
5. history of cancer
boolean
C0006826 (UMLS CUI [1])
Current Smoker | Smoking cigarettes: ____ pack-years history
Item
6. current tobacco smoking or a history of tobacco smoking for ≥10 pack-years.
boolean
C3241966 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Received tralokinumab
Item
7. previous receipt of tralokinumab
boolean
C1514756 (UMLS CUI [1,1])
C3658667 (UMLS CUI [1,2])
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