ID

14216

Descrizione

A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 5-11 Years Old With Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02040766

collegamento

https://clinicaltrials.gov/show/NCT02040766

Keywords

versioni (1)
  1. 04/04/16 04/04/16 -
Caricato su

4 aprile 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Asthma NCT02040766

Inglese

Eligibility Asthma NCT02040766

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02040766
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
asthma diagnosis: the patient has a diagnosis of asthma as defined by the national institute of health (nih). the asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days before screening visit
Descrizione

Asthma | Stable status

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0027468
severity of disease: the patient has persistent asthma, with a forced expiratory volume in 1 second (fev1) 40 percent to 90 percent of the value predicted for age, height, and sex at screening visit (sv)
Descrizione

Severe persistent asthma | FEV1

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1960048
UMLS CUI [2]
C0748133
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0005890
UMLS CUI [5]
C0079399
current asthma therapy: the patient is currently being treated with 1 of the following: 1) a stable daily dosage of an inhaled corticosteroid (ics) in the range of 88-176 mcg/day of fluticasone propionate (or equivalent) for a minimum of 4 weeks (28 days) before screening visit 2) a stable daily dosage of non-corticosteroid therapy 3) a daily dose of ics plus a long-acting beta2-agonist (laba) (at a dose less than or equivalent to fluticasone propionate 100 mcg/salmeterol 50 mcg twice daily)
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C2065041
UMLS CUI [3]
C0117996
UMLS CUI [4]
C0149783
UMLS CUI [5]
C2936789
UMLS CUI [6]
C0073992
reversibility of disease: the patient has demonstrated at least 12% reversibility of fev1 within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (hfa) mdi (90 mcg ex-actuator) or equivalent at screening visit or on retesting.
Descrizione

disease reversibility | FEV1 | Albuterol | HYDROFLUOROALKANE

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0679253
UMLS CUI [2]
C0748133
UMLS CUI [3]
C0001927
UMLS CUI [4]
C1721232
other criteria apply, please contact the investigator for more information
Descrizione

Inclusion criteria | Other

Tipo di dati

boolean

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

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 hypercapnia, respiratory arrest, or hypoxic seizures.
Descrizione

Asthma | Life Threatening | Intubation | Hypercapnia | Respiratory arrest | Hypoxic convulsions

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0021925
UMLS CUI [3]
C0020440
UMLS CUI [4]
C0162297
UMLS CUI [5]
C1843573
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). any patient becoming pregnant during the study will be withdrawn from the study.
Descrizione

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo di dati

boolean

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

Hypersensitivity | Adrenal Cortex Hormones | Investigational New Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001617
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
the patient has used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco, as applicable).
Descrizione

Tobacco use | Cigarette | Cigars | Oral Tobacco | pipe tobacco

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C0677453
UMLS CUI [3]
C0678446
UMLS CUI [4]
C0008038
UMLS CUI [5]
C0678447
the patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before screening visit, or has had any hospitalization for asthma within 2 months before screening visit.
Descrizione

Exacerbation of asthma | Adrenal Cortex Hormones | Hospitalization | Asthma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0001617
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
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.
Descrizione

Disease | Study Subject Participation Status | Limited

Tipo di dati

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
Descrizione

Exclusion Criteria | Other

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205394
Ritorna all'inizio della pagina

Similar models

Eligibility Asthma NCT02040766

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02040766
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Asthma | Stable status
Item
asthma diagnosis: the patient has a diagnosis of asthma as defined by the national institute of health (nih). the asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days before screening visit
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0027468 (UMLS CUI [2])
Severe persistent asthma | FEV1
Item
severity of disease: the patient has persistent asthma, with a forced expiratory volume in 1 second (fev1) 40 percent to 90 percent of the value predicted for age, height, and sex at screening visit (sv)
boolean
C1960048 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0005890 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
Therapeutic procedure | Asthma | inhaled steroids | Fluticasone propionate | Steroid therapy | Adrenergic beta-2 Receptor Agonists | salmeterol
Item
current asthma therapy: the patient is currently being treated with 1 of the following: 1) a stable daily dosage of an inhaled corticosteroid (ics) in the range of 88-176 mcg/day of fluticasone propionate (or equivalent) for a minimum of 4 weeks (28 days) before screening visit 2) a stable daily dosage of non-corticosteroid therapy 3) a daily dose of ics plus a long-acting beta2-agonist (laba) (at a dose less than or equivalent to fluticasone propionate 100 mcg/salmeterol 50 mcg twice daily)
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C0117996 (UMLS CUI [3])
C0149783 (UMLS CUI [4])
C2936789 (UMLS CUI [5])
C0073992 (UMLS CUI [6])
disease reversibility | FEV1 | Albuterol | HYDROFLUOROALKANE
Item
reversibility of disease: the patient has demonstrated at least 12% reversibility of fev1 within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (hfa) mdi (90 mcg ex-actuator) or equivalent at screening visit or on retesting.
boolean
C0679253 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0001927 (UMLS CUI [3])
C1721232 (UMLS CUI [4])
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)
Asthma | Life Threatening | Intubation | Hypercapnia | Respiratory arrest | Hypoxic convulsions
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 hypercapnia, respiratory arrest, or hypoxic seizures.
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0021925 (UMLS CUI [2])
C0020440 (UMLS CUI [3])
C0162297 (UMLS CUI [4])
C1843573 (UMLS CUI [5])
Pregnancy | Breast Feeding | Pregnancy, Planned
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). 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])
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])
Tobacco use | Cigarette | Cigars | Oral Tobacco | pipe tobacco
Item
the patient has used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco, as applicable).
boolean
C0543414 (UMLS CUI [1])
C0677453 (UMLS CUI [2])
C0678446 (UMLS CUI [3])
C0008038 (UMLS CUI [4])
C0678447 (UMLS CUI [5])
Exacerbation of asthma | Adrenal Cortex Hormones | Hospitalization | Asthma
Item
the patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before screening visit, or has had any hospitalization for asthma within 2 months before screening visit.
boolean
C0349790 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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