ID

14205

Descripción

A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02031640

Link

https://clinicaltrials.gov/show/NCT02031640

Palabras clave

Versiones (1)
  1. 4/4/16 4/4/16 -
Subido en

4 de abril de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Asthma DRKS00005827 NCT02031640

Inglés

Eligibility Asthma NCT02031640

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02031640
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
severity of disease: the patient has persistent asthma, with a forced expiratory volume in 1 second (fev1) 40 percent - 85 percent of the value predicted for age, height, sex, and race as per the national health and nutrition examination survey (nhanes iii) (hankinson et al 1999) reference values at screening visit.
Descripción

Severe persistent asthma | FEV1 | Third National Health and Nutrition Examination Survey

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960048
UMLS CUI [2,1]
C0748133
UMLS CUI [2,2]
C0001779
UMLS CUI [3]
C0005890
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0034510
UMLS CUI [6]
C2825743
current asthma therapy: the patient must be on a stable dose of an inhaled corticosteroid (ics) of at least 440 mcg/day of fluticasone propionate or equivalent for a minimum of 4 weeks before screening visit, or any inhaled corticosteroid/long-acting beta2-agonist (ics/laba) combination for a minimum of 4 weeks before the prescreening visit.
Descripción

Therapeutic procedure | Asthma | inhaled steroids | Fluticasone propionate | Adrenergic beta-2 Receptor Agonists

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C2065041
UMLS CUI [3]
C0117996
UMLS CUI [4]
C2936789
reversibility of disease: the patient has demonstrated at least 12% reversibility of fev1 and at least 200 ml increase from baseline fev1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (hfa) mdi (90 mcg ex-actuator) or equivalent at the screening visit
Descripción

Age | disease reversibility | FEV1 | Albuterol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0679253
UMLS CUI [3]
C0748133
UMLS CUI [4]
C0001927
if female, the patient is currently not pregnant, breast feeding, or attempting to become pregnant. if of childbearing potential, has a negative serum pregnancy test and is willing to commit to using a consistent and acceptable method of birth control.
Descripción

Not pregnant (finding) | Not Lactating | Pregnancy, Planned | Childbearing Potential | Serum pregnancy test negative | Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232973
UMLS CUI [2]
C2826207
UMLS CUI [3]
C0032992
UMLS CUI [4]
C3831118
UMLS CUI [5]
C0430061
UMLS CUI [6]
C0700589
other criteria apply, please contact the investigator for more information
Descripción

Inclusion criteria | Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
Descripción

Severe asthma | Life Threatening | Intubation | Respiratory arrest | Hypoxia | Seizures

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0581126
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0021925
UMLS CUI [3]
C0162297
UMLS CUI [4,1]
C0242184
UMLS CUI [4,2]
C0036572
the patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient's last study-related visit (for eligible patients only, if applicable). eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. any patient becoming pregnant during the study will be withdrawn from the study.
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0700589
the patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
Descripción

Hypersensitivity | Adrenal Cortex Hormones | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001617
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
the patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year).
Descripción

Current Smoker | smoking cigarettes: ____ pack-years history

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3241966
UMLS CUI [2]
C2230126
the patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before the screening visit, or has had any hospitalization for asthma within 2 months before the screening visit.
Descripción

Exacerbation of asthma | Adrenal Cortex Hormones | Hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0001617
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0004096
the patient has historical or current evidence of a clinically significant disease. significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
Descripción

Disease | Study Subject Participation Status | Limited

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
other criteria apply, please contact the investigator for more information
Descripción

Exclusion Criteria | Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Asthma NCT02031640

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02031640
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Severe persistent asthma | FEV1 | Third National Health and Nutrition Examination Survey
Item
severity of disease: the patient has persistent asthma, with a forced expiratory volume in 1 second (fev1) 40 percent - 85 percent of the value predicted for age, height, sex, and race as per the national health and nutrition examination survey (nhanes iii) (hankinson et al 1999) reference values at screening visit.
boolean
C1960048 (UMLS CUI [1])
C0748133 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0005890 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0034510 (UMLS CUI [5])
C2825743 (UMLS CUI [6])
Therapeutic procedure | Asthma | inhaled steroids | Fluticasone propionate | Adrenergic beta-2 Receptor Agonists
Item
current asthma therapy: the patient must be on a stable dose of an inhaled corticosteroid (ics) of at least 440 mcg/day of fluticasone propionate or equivalent for a minimum of 4 weeks before screening visit, or any inhaled corticosteroid/long-acting beta2-agonist (ics/laba) combination for a minimum of 4 weeks before the prescreening visit.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3])
C2936789 (UMLS CUI [4])
Age | disease reversibility | FEV1 | Albuterol
Item
reversibility of disease: the patient has demonstrated at least 12% reversibility of fev1 and at least 200 ml increase from baseline fev1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (hfa) mdi (90 mcg ex-actuator) or equivalent at the screening visit
boolean
C0001779 (UMLS CUI [1])
C0679253 (UMLS CUI [2])
C0748133 (UMLS CUI [3])
C0001927 (UMLS CUI [4])
Not pregnant (finding) | Not Lactating | Pregnancy, Planned | Childbearing Potential | Serum pregnancy test negative | Contraceptive methods
Item
if female, the patient is currently not pregnant, breast feeding, or attempting to become pregnant. if of childbearing potential, has a negative serum pregnancy test and is willing to commit to using a consistent and acceptable method of birth control.
boolean
C0232973 (UMLS CUI [1])
C2826207 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4])
C0430061 (UMLS CUI [5])
C0700589 (UMLS CUI [6])
Inclusion criteria | Other
Item
other criteria apply, please contact the investigator for more information
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Severe asthma | Life Threatening | Intubation | Respiratory arrest | Hypoxia | Seizures
Item
the patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
boolean
C0581126 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0021925 (UMLS CUI [2])
C0162297 (UMLS CUI [3])
C0242184 (UMLS CUI [4,1])
C0036572 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods
Item
the patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient's last study-related visit (for eligible patients only, if applicable). eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. any patient becoming pregnant during the study will be withdrawn from the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Hypersensitivity | Adrenal Cortex Hormones | Investigational New Drugs
Item
the patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
boolean
C0020517 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Current Smoker | smoking cigarettes: ____ pack-years history
Item
the patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year).
boolean
C3241966 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
Exacerbation of asthma | Adrenal Cortex Hormones | Hospitalization
Item
the patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before the screening visit, or has had any hospitalization for asthma within 2 months before the screening visit.
boolean
C0349790 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Disease | Study Subject Participation Status | Limited
Item
the patient has historical or current evidence of a clinically significant disease. significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Exclusion Criteria | Other
Item
other criteria apply, please contact the investigator for more information
boolean
C0680251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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