ID

43945

Beskrivning

A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.; ODM derived from: https://clinicaltrials.gov/show/NCT01928368

Länk

https://clinicaltrials.gov/show/NCT01928368

Nyckelord

Versioner (2)
  1. 2016-03-31 2016-03-31 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Asthma NCT01928368

Engelsk

Eligibility Asthma NCT01928368

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01928368
Criteria
Beskrivning

Criteria

is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years.
Beskrivning

Non-smoker

Datatyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0037390
UMLS CUI [3]
C0008038
UMLS CUI [4]
C0678446
UMLS CUI [5]
C0677453
UMLS CUI [6]
C0240766
UMLS CUI [7]
C0358855
UMLS CUI [8]
C2230126
females must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; or history of hysterectomy; or history of bilateral salpingectomy; or history of bilateral oophorectomy).
Beskrivning

Female | Postmenopausal state | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0086287
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0232970
UMLS CUI [3]
C0020699
UMLS CUI [4]
C2243030
UMLS CUI [5]
C0278321
body mass index (bmi) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (subjects with mild atopic asthma only)
Beskrivning

Mild allergic asthma | Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C4040757
UMLS CUI [2]
C1305855
documented history of mild, stable atopic asthma within 2 years of screening.
Beskrivning

Mild allergic asthma | Stable status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4040757
UMLS CUI [1,2]
C0205360
has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma.
Beskrivning

Therapeutic procedure | Asthma | Adrenergic beta-2 Receptor Agonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C2936789
pre-bronchodilator forced expiratory volume in 1 second (fev1) > 70 percent predicted at screening.
Beskrivning

FEV1 | pre-bronchodilator

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
(all subjects)
Beskrivning

ID.7

Datatyp

boolean

history or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Beskrivning

Disease | Study Subject Participation Status | Limited

Datatyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0439801
subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (ppd) or quantiferon test at screening. subjects with a documented negative ppd or quantiferon test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
Beskrivning

Exposure to tuberculosis | positive purified protein derivative (ppd) | Quantiferon test

Datatyp

boolean

Alias
UMLS CUI [1]
C0149796
UMLS CUI [2]
C0199176
UMLS CUI [3]
C0032739
UMLS CUI [4,1]
C1875713
UMLS CUI [4,2]
C0392366
has donated or lost ≥ 500 ml of blood or plasma within 8 weeks of administration of the first dose of ip.
Beskrivning

Blood Donation | Blood Loss | Immunoprecipitation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C3163616
UMLS CUI [3]
C0021069
other criteria may apply.
Beskrivning

Other criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0205394
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Similar models

Eligibility Asthma NCT01928368

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01928368
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Non-smoker
Item
is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years.
boolean
C0337672 (UMLS CUI [1])
C0037390 (UMLS CUI [2])
C0008038 (UMLS CUI [3])
C0678446 (UMLS CUI [4])
C0677453 (UMLS CUI [5])
C0240766 (UMLS CUI [6])
C0358855 (UMLS CUI [7])
C2230126 (UMLS CUI [8])
Female | Postmenopausal state | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy
Item
females must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; or history of hysterectomy; or history of bilateral salpingectomy; or history of bilateral oophorectomy).
boolean
C0086287 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C0020699 (UMLS CUI [3])
C2243030 (UMLS CUI [4])
C0278321 (UMLS CUI [5])
Mild allergic asthma | Body mass index
Item
body mass index (bmi) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (subjects with mild atopic asthma only)
boolean
C4040757 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Mild allergic asthma | Stable status
Item
documented history of mild, stable atopic asthma within 2 years of screening.
boolean
C4040757 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Therapeutic procedure | Asthma | Adrenergic beta-2 Receptor Agonists
Item
has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2])
FEV1 | pre-bronchodilator
Item
pre-bronchodilator forced expiratory volume in 1 second (fev1) > 70 percent predicted at screening.
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
(all subjects)
boolean
Disease | Study Subject Participation Status | Limited
Item
history or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
boolean
C0012634 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Exposure to tuberculosis | positive purified protein derivative (ppd) | Quantiferon test
Item
subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (ppd) or quantiferon test at screening. subjects with a documented negative ppd or quantiferon test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
boolean
C0149796 (UMLS CUI [1])
C0199176 (UMLS CUI [2])
C0032739 (UMLS CUI [3])
C1875713 (UMLS CUI [4,1])
C0392366 (UMLS CUI [4,2])
Blood Donation | Blood Loss | Immunoprecipitation
Item
has donated or lost ≥ 500 ml of blood or plasma within 8 weeks of administration of the first dose of ip.
boolean
C0005794 (UMLS CUI [1])
C3163616 (UMLS CUI [2])
C0021069 (UMLS CUI [3])
Other criteria
Item
other criteria may apply.
boolean
C0205394 (UMLS CUI [1])
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