ID

43925

Beschreibung

Study of Efficacy and Safety of Brodalumab Compared With Placebo in Inadequately Controlled Asthma Subjects With High Bronchodilator Reversibility; ODM derived from: https://clinicaltrials.gov/show/NCT01902290

Link

https://clinicaltrials.gov/show/NCT01902290

Stichworte

Versionen (2)
  1. 29.03.16 29.03.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Asthma NCT01902290

Englisch

Eligibility Asthma NCT01902290

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01902290
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of asthma, and presently has reversibility over pre-bronchodilator fev1 of
Beschreibung

Asthma | Reversibility | pre bronchodilator | FEV1

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0449261
UMLS CUI [1,3]
C2599602
UMLS CUI [1,4]
C0748133
≥ 20 percent at screening
Beschreibung

FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
percent of predicted fev1 ≥ 40% and ≤ 80% at screening
Beschreibung

Percent predicted FEV1

Datentyp

boolean

Alias
UMLS CUI [1]
C0730561
ics ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
Beschreibung

Inhaled steroids | fluticasone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0082607
ongoing asthma symptoms with acq composite score at screening and baseline ≥ 1.5 points
Beschreibung

Score | Asthma control questionnaire | Asthma | Symptoms | Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C2919686
UMLS CUI [1,3]
C0004096
UMLS CUI [1,4]
C1457887
UMLS CUI [1,5]
C0549178
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
Beschreibung

Chronic Obstructive Airway Disease | Other chronic pulmonary disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2,1]
C0810290
UMLS CUI [2,2]
C0004096
history of allergic bronchopulmonary aspergillosis
Beschreibung

Aspergillosis, Allergic Bronchopulmonary

Datentyp

boolean

Alias
UMLS CUI [1]
C0004031
respiratory infection within 4 weeks of screening or 1 week of baseline visit
Beschreibung

Respiratory Tract Infections

Datentyp

boolean

Alias
UMLS CUI [1]
C0035243
subject has known history of crohn's disease subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
Beschreibung

Crohn Disease | Comorbidity | Laboratory abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0010346
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1853129
subject has previously used any anti-il17 biologic therapy
Beschreibung

Interleukin-17 | Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0384648
UMLS CUI [1,2]
C0087111
subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
Beschreibung

Female | Unwilling | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0700589
subject has severe depression measured by personal health questionnaire depression scale (phq-8) or suicidal ideation/behavior as measured by and columbia suicide severity rating scale (e-cssrs)
Beschreibung

Severe depression | Suicidal behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0588008
UMLS CUI [1,2]
C0679604
UMLS CUI [2,1]
C1760428
UMLS CUI [2,2]
C3888485
subject has a history or evidence of psychiatric disorder or substance abuse considered by the investigator to pose a risk to subject safety
Beschreibung

Mental disorders | Substance abuse problem

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0740858
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C1113679
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Ähnliche Modelle

Eligibility Asthma NCT01902290

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01902290
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Asthma | Reversibility | pre bronchodilator | FEV1
Item
diagnosis of asthma, and presently has reversibility over pre-bronchodilator fev1 of
boolean
C0004096 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
C2599602 (UMLS CUI [1,3])
C0748133 (UMLS CUI [1,4])
FEV1
Item
≥ 20 percent at screening
boolean
C0748133 (UMLS CUI [1])
Percent predicted FEV1
Item
percent of predicted fev1 ≥ 40% and ≤ 80% at screening
boolean
C0730561 (UMLS CUI [1])
Inhaled steroids | fluticasone
Item
ics ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
boolean
C2065041 (UMLS CUI [1,1])
C0082607 (UMLS CUI [1,2])
Score | Asthma control questionnaire | Asthma | Symptoms | Continuous
Item
ongoing asthma symptoms with acq composite score at screening and baseline ≥ 1.5 points
boolean
C0449820 (UMLS CUI [1,1])
C2919686 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
Chronic Obstructive Airway Disease | Other chronic pulmonary disease
Item
history of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
boolean
C0024117 (UMLS CUI [1])
C0810290 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Aspergillosis, Allergic Bronchopulmonary
Item
history of allergic bronchopulmonary aspergillosis
boolean
C0004031 (UMLS CUI [1])
Respiratory Tract Infections
Item
respiratory infection within 4 weeks of screening or 1 week of baseline visit
boolean
C0035243 (UMLS CUI [1])
Crohn Disease | Comorbidity | Laboratory abnormalities
Item
subject has known history of crohn's disease subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
boolean
C0010346 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C1853129 (UMLS CUI [2,2])
Interleukin-17 | Therapeutic procedure
Item
subject has previously used any anti-il17 biologic therapy
boolean
C0384648 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Female | Unwilling | Contraceptive methods
Item
female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
boolean
C0086287 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Severe depression | Suicidal behavior
Item
subject has severe depression measured by personal health questionnaire depression scale (phq-8) or suicidal ideation/behavior as measured by and columbia suicide severity rating scale (e-cssrs)
boolean
C0588008 (UMLS CUI [1,1])
C0679604 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2,1])
C3888485 (UMLS CUI [2,2])
Mental disorders | Substance abuse problem
Item
subject has a history or evidence of psychiatric disorder or substance abuse considered by the investigator to pose a risk to subject safety
boolean
C0004936 (UMLS CUI [1])
C0740858 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
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