ID

43945

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01928368

Trefwoorden

Versies (2)
  1. 31-03-16 31-03-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Asthma NCT01928368

Engels

Eligibility Asthma NCT01928368

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01928368
Criteria
Beschrijving

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.
Beschrijving

Non-smoker

Datatype

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).
Beschrijving

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

Datatype

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)
Beschrijving

Mild allergic asthma | Body mass index

Datatype

boolean

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

Mild allergic asthma | Stable status

Datatype

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.
Beschrijving

Therapeutic procedure | Asthma | Adrenergic beta-2 Receptor Agonists

Datatype

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.
Beschrijving

FEV1 | pre-bronchodilator

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
(all subjects)
Beschrijving

ID.7

Datatype

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.
Beschrijving

Disease | Study Subject Participation Status | Limited

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Blood Donation | Blood Loss | Immunoprecipitation

Datatype

boolean

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

Other criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0205394
Terug naar het begin van de pagina

Similar models

Eligibility Asthma NCT01928368

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01928368
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial