ID

14492

Descripción

A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands; ODM derived from: https://clinicaltrials.gov/show/NCT00657774

Link

https://clinicaltrials.gov/show/NCT00657774

Palabras clave

Versiones (1)
  1. 18/4/16 18/4/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

18 de abril de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00657774

Inglés

Eligibility Asthma NCT00657774

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00657774
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-65 at the screening visit;
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
history of asthma for at least 6 months prior to screening visit
Descripción

history of asthma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0040223
well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to screening visit
Descripción

short acting beta agonist

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001927
female subjects that are not pregnant or lactating
Descripción

pregnancy or lactation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
otherwise healthy as determined by the investigator.
Descripción

healthy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708335
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
life-threatening asthma within the past year or visit to emergency room for asthma in the past 3 months prior to the screening visit;
Descripción

life-threatening asthma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0040223
UMLS CUI [2]
C0583237
significant,nonreversible pulmonary disease (e.g. chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis)
Descripción

pulmonary disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024115
use of any steroid medications, topical or inhaled steroids within 4 weeks or systemic (oral or injectable) steroids within 3 months of dosing
Descripción

steroid

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038317
an upper or lower respiratory tract infection within the last 4 weeks pior to screening visit or acute illness or infection within 6 weeks prior to dosing
Descripción

respiratory tract infection comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0009488
any significant disease or major disorder that may jeopardize subject safety
Descripción

comorbidity limiting study protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
history of tabacco use within 6 months prior to dosing and/or smoking history > 10 pack-years
Descripción

smoking history

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
UMLS CUI [1,3]
C0040223
female subjects on hormone replacement therapy or using birth control involving hormones in the past 6 months
Descripción

hormone replacement therapy hormonal contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C2985296
additional inclusion and exclusion criteria will evaluated by the investigator.
Descripción

criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242801
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Similar models

Eligibility Asthma NCT00657774

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00657774
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age 18-65 at the screening visit;
boolean
C0001779 (UMLS CUI [1])
history of asthma
Item
history of asthma for at least 6 months prior to screening visit
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
short acting beta agonist
Item
well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to screening visit
boolean
C0001927 (UMLS CUI [1])
pregnancy or lactation
Item
female subjects that are not pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
healthy
Item
otherwise healthy as determined by the investigator.
boolean
C1708335 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
life-threatening asthma
Item
life-threatening asthma within the past year or visit to emergency room for asthma in the past 3 months prior to the screening visit;
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0583237 (UMLS CUI [2])
pulmonary disease
Item
significant,nonreversible pulmonary disease (e.g. chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis)
boolean
C0024115 (UMLS CUI [1])
steroid
Item
use of any steroid medications, topical or inhaled steroids within 4 weeks or systemic (oral or injectable) steroids within 3 months of dosing
boolean
C0038317 (UMLS CUI [1])
respiratory tract infection comorbidity
Item
an upper or lower respiratory tract infection within the last 4 weeks pior to screening visit or acute illness or infection within 6 weeks prior to dosing
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
comorbidity limiting study protocol
Item
any significant disease or major disorder that may jeopardize subject safety
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
smoking history
Item
history of tabacco use within 6 months prior to dosing and/or smoking history > 10 pack-years
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
hormone replacement therapy hormonal contraception
Item
female subjects on hormone replacement therapy or using birth control involving hormones in the past 6 months
boolean
C0282402 (UMLS CUI [1])
C2985296 (UMLS CUI [2])
criteria
Item
additional inclusion and exclusion criteria will evaluated by the investigator.
boolean
C0242801 (UMLS CUI [1])
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