ID

14225

Beschreibung

Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02054130

Link

https://clinicaltrials.gov/show/NCT02054130

Stichworte

Versionen (1)
  1. 05.04.16 05.04.16 -
Hochgeladen am

5. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Asthma NCT02054130

Englisch

Eligibility Asthma NCT02054130

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02054130
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 through 75
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
bmi between 18-40 kg/m2 and weight greater than or equal 40 kg
Beschreibung

Body mass index | Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
documented physician-diagnosed asthma - subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose ics plus laba -if on asthma controller medications in addition to ics plus laba, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ics, lama, cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -subjects must have a documented history of at least 2 asthma exacerbation events or at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit.
Beschreibung

Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists | Leukotriene Antagonists | Theophylline | Anticholinergic Agents | Chromones | Prednisone Oral Product | Exacerbation of asthma | Exacerbation of severe persistent asthma | Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C2065041
UMLS CUI [3]
C2936789
UMLS CUI [4]
C0595726
UMLS CUI [5]
C0039771
UMLS CUI [6]
C0242896
UMLS CUI [7]
C0008594
UMLS CUI [8]
C3216040
UMLS CUI [9]
C0349790
UMLS CUI [10]
C3508930
UMLS CUI [11]
C0019993
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma.
Beschreibung

Vocal Cord Dysfunction | Reactive airways dysfunction syndrome | Hyperventilation | Panic Attacks | Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0859897
UMLS CUI [2]
C1299633
UMLS CUI [3]
C0020578
UMLS CUI [4]
C0086769
UMLS CUI [5]
C0004096
current smokers or subjects with a smoking history of ≥ 10 pack years
Beschreibung

Current Smoker | smoking cigarettes: ____ pack-years history

Datentyp

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C2230126
former smokers with < 10 pack years must have stopped for at least 1 year to be eligible.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C2230126
UMLS CUI [2]
C0425310
any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, churg-strauss syndrome).
Beschreibung

Disease | Study Subject Participation Status | Limited | Chronic Obstructive Airway Disease | Cystic Fibrosis | Pulmonary Fibrosis | Bronchiectasis | Aspergillosis, Allergic Bronchopulmonary | Churg-Strauss Syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0010674
UMLS CUI [4]
C0034069
UMLS CUI [5]
C0006267
UMLS CUI [6]
C0004031
UMLS CUI [7]
C0008728
evidence of active liver disease.
Beschreibung

Liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
history of cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -known history of active tuberculosis (tb)
Beschreibung

Malignant Neoplasms | Basal cell carcinoma | Cervix carcinoma | In situ | Tuberculosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3,1]
C0302592
UMLS CUI [3,2]
C0444498
UMLS CUI [4]
C0041296
history of anaphylaxis to any biologic therapy
Beschreibung

Anaphylaxis | Biological Response Modifier Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0005527
positive medical history for hepatitis b or c
Beschreibung

Hepatitis B positive | Hepatitis C positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
subject with hiv or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
Beschreibung

HIV | Anti-Retroviral Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0599685
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Ähnliche Modelle

Eligibility Asthma NCT02054130

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02054130
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 through 75
boolean
C0001779 (UMLS CUI [1])
Body mass index | Body Weight
Item
bmi between 18-40 kg/m2 and weight greater than or equal 40 kg
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Asthma | inhaled steroids | Adrenergic beta-2 Receptor Agonists | Leukotriene Antagonists | Theophylline | Anticholinergic Agents | Chromones | Prednisone Oral Product | Exacerbation of asthma | Exacerbation of severe persistent asthma | Hospitalization
Item
documented physician-diagnosed asthma - subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose ics plus laba -if on asthma controller medications in addition to ics plus laba, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ics, lama, cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -subjects must have a documented history of at least 2 asthma exacerbation events or at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit.
boolean
C0004096 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C2936789 (UMLS CUI [3])
C0595726 (UMLS CUI [4])
C0039771 (UMLS CUI [5])
C0242896 (UMLS CUI [6])
C0008594 (UMLS CUI [7])
C3216040 (UMLS CUI [8])
C0349790 (UMLS CUI [9])
C3508930 (UMLS CUI [10])
C0019993 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
Vocal Cord Dysfunction | Reactive airways dysfunction syndrome | Hyperventilation | Panic Attacks | Asthma
Item
diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma.
boolean
C0859897 (UMLS CUI [1])
C1299633 (UMLS CUI [2])
C0020578 (UMLS CUI [3])
C0086769 (UMLS CUI [4])
C0004096 (UMLS CUI [5])
Current Smoker | smoking cigarettes: ____ pack-years history
Item
current smokers or subjects with a smoking history of ≥ 10 pack years
boolean
C3241966 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Former smoker | smoking cigarettes: ____ pack-years history | Stopped smoking
Item
former smokers with < 10 pack years must have stopped for at least 1 year to be eligible.
boolean
C0337671 (UMLS CUI [1,1])
C2230126 (UMLS CUI [1,2])
C0425310 (UMLS CUI [2])
Disease | Study Subject Participation Status | Limited | Chronic Obstructive Airway Disease | Cystic Fibrosis | Pulmonary Fibrosis | Bronchiectasis | Aspergillosis, Allergic Bronchopulmonary | Churg-Strauss Syndrome
Item
any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, churg-strauss syndrome).
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0024117 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0034069 (UMLS CUI [4])
C0006267 (UMLS CUI [5])
C0004031 (UMLS CUI [6])
C0008728 (UMLS CUI [7])
Liver disease
Item
evidence of active liver disease.
boolean
C0023895 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma | Cervix carcinoma | In situ | Tuberculosis
Item
history of cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -known history of active tuberculosis (tb)
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0302592 (UMLS CUI [3,1])
C0444498 (UMLS CUI [3,2])
C0041296 (UMLS CUI [4])
Anaphylaxis | Biological Response Modifier Therapy
Item
history of anaphylaxis to any biologic therapy
boolean
C0002792 (UMLS CUI [1,1])
C0005527 (UMLS CUI [1,2])
Hepatitis B positive | Hepatitis C positive
Item
positive medical history for hepatitis b or c
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
HIV | Anti-Retroviral Agents
Item
subject with hiv or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
boolean
C0019682 (UMLS CUI [1])
C0599685 (UMLS CUI [2])
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