ID

14253

Beskrivning

Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Patients With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02062463

Länk

https://clinicaltrials.gov/show/NCT02062463

Nyckelord

Versioner (1)
  1. 5/4/16 5/4/16 -
Uppladdad den

5 de abril de 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Asthma NCT02062463

Engelsk

Eligibility Asthma NCT02062463

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02062463
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent signed and dated by the adult patient before conducting any study related procedures.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0807937
the patient is a man or woman 18 through 75 years of age as of the screening visit.
Beskrivning

Age | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
the patient has a diagnosis of asthma in accordance with global initiative for asthma (gina) criteria as evidenced by a united kingdom (uk) quality outcome framework approved read code (uk diagnostic coding system).
Beskrivning

Asthma

Datatyp

boolean

Alias
UMLS CUI [1]
C0004096
the patient is receiving step 3 or 4 therapy for asthma as defined by the british thoracic society (bts) guidelines (daily doses of bdp-equivalent inhaled corticosteroid (ics) ≥800 mcg to 2000 mcg as part of fixed or free combinations with long-acting beta-agonists (laba).
Beskrivning

Therapeutic procedure | Asthma | Beclomethasone Dipropionate | inhaled steroids | Adrenergic beta-2 Receptor Agonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [2]
C0004906
UMLS CUI [3]
C2065041
UMLS CUI [4]
C2936789
if patient is a female of childbearing potential (postmenarche or less than 2 years post-menopausal or not surgically sterile) the patient must be willing to commit to using a medically accepted method of contraception for the duration of study and 30 days after discontinuing study drug.
Beskrivning

Childbearing Potential | Menarche | Post | Postmenopausal state | Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0025274
UMLS CUI [2,2]
C0687676
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0700589
the patient, as judged by the investigator, must be willing and able to understand risks and benefits of study participation to give informed consent and to comply with all study requirements as specified in this protocol for the entire duration of their study participation.
Beskrivning

Study Subject Participation Status | Informed Consent | Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1321605
the patient is spiromax and turbohaler naïve (no use of a turbohaler device in the last 6 months, minimizing carryover from prior device use).
Beskrivning

Metered Dose Inhaler | Use of

Datatyp

boolean

Alias
UMLS CUI [1]
C0993596
UMLS CUI [2]
C1524063
if female, the patient must have a negative urine pregnancy test. o other criteria apply, please contact the investigator for additional information
Beskrivning

Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0430057
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has any clinically significant uncontrolled medical condition (treated or untreated) that, in the judgment of the investigator, will cause participation in the study to be detrimental to the patient.
Beskrivning

Disease | Study Subject Participation Status | Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
the patient has participated in a teva sponsored clinical study with bf spiromax in the last 6 months.
Beskrivning

Study Subject Participation Status | Budesonide / formoterol

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1276807
the patient is a pregnant, attempting to become pregnant, or breast feeding. (any woman becoming pregnant during the study will be withdrawn from the study.)
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
the patient has used a clinical trial investigational drug within 1 month before the screening visit.
Beskrivning

Investigational New Drugs | Use of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1524063
the patient has an ongoing asthma exacerbation or has received ocs and/or antibiotics for a lower respiratory condition (proxy measure for identifying an asthma exacerbation and/or lower respiratory infection, suggestive of altered inspiratory capabilities) in the 2 weeks preceding visit
Beskrivning

Exacerbation of asthma | Adrenal Cortex Hormones | Antibiotics | Lower respiratory tract infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0001617
UMLS CUI [3,1]
C0003232
UMLS CUI [3,2]
C0149725
the patient is currently receiving any ocs (including long or short courses).
Beskrivning

Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
the patient has a significant chronic lower respiratory tract disease other than asthma eg chronic obstructive pulmonary disease (copd), cystic fibrosis or interstitial lung disease. conditions that are not predominant, such as minor degrees of bronchiectasis, are not a reason for exclusion.
Beskrivning

chronic lower respiratory disease | Chronic Obstructive Airway Disease | Cystic Fibrosis | Lung Diseases, Interstitial | Bronchiectasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0348692
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0010674
UMLS CUI [4]
C0206062
UMLS CUI [5]
C0006267
the patient has a known allergy or severe sensitivity to the constituents of the study drugs (spiromax or turbohaler) eg, to lactose or to milk protein.
Beskrivning

Hypersensitivity | Metered Dose Inhaler | Lactose | Milk Proteins

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0993596
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0022949
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0026138
other criteria apply, please contact the investigator for additional information
Beskrivning

Exclusion Criteria | Other

Datatyp

boolean

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

Eligibility Asthma NCT02062463

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02062463
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
written informed consent signed and dated by the adult patient before conducting any study related procedures.
boolean
C0021430 (UMLS CUI [1,1])
C0807937 (UMLS CUI [1,2])
Age | Gender
Item
the patient is a man or woman 18 through 75 years of age as of the screening visit.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Asthma
Item
the patient has a diagnosis of asthma in accordance with global initiative for asthma (gina) criteria as evidenced by a united kingdom (uk) quality outcome framework approved read code (uk diagnostic coding system).
boolean
C0004096 (UMLS CUI [1])
Therapeutic procedure | Asthma | Beclomethasone Dipropionate | inhaled steroids | Adrenergic beta-2 Receptor Agonists
Item
the patient is receiving step 3 or 4 therapy for asthma as defined by the british thoracic society (bts) guidelines (daily doses of bdp-equivalent inhaled corticosteroid (ics) ≥800 mcg to 2000 mcg as part of fixed or free combinations with long-acting beta-agonists (laba).
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0004906 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C2936789 (UMLS CUI [4])
Childbearing Potential | Menarche | Post | Postmenopausal state | Contraceptive methods
Item
if patient is a female of childbearing potential (postmenarche or less than 2 years post-menopausal or not surgically sterile) the patient must be willing to commit to using a medically accepted method of contraception for the duration of study and 30 days after discontinuing study drug.
boolean
C3831118 (UMLS CUI [1])
C0025274 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Study Subject Participation Status | Informed Consent | Compliance behavior
Item
the patient, as judged by the investigator, must be willing and able to understand risks and benefits of study participation to give informed consent and to comply with all study requirements as specified in this protocol for the entire duration of their study participation.
boolean
C2348568 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Metered Dose Inhaler | Use of
Item
the patient is spiromax and turbohaler naïve (no use of a turbohaler device in the last 6 months, minimizing carryover from prior device use).
boolean
C0993596 (UMLS CUI [1])
C1524063 (UMLS CUI [2])
Urine pregnancy test negative
Item
if female, the patient must have a negative urine pregnancy test. o other criteria apply, please contact the investigator for additional information
boolean
C0430057 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease | Study Subject Participation Status | Limited
Item
the patient has any clinically significant uncontrolled medical condition (treated or untreated) that, in the judgment of the investigator, will cause participation in the study to be detrimental to the patient.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Study Subject Participation Status | Budesonide / formoterol
Item
the patient has participated in a teva sponsored clinical study with bf spiromax in the last 6 months.
boolean
C2348568 (UMLS CUI [1])
C1276807 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
the patient is a pregnant, attempting to become pregnant, or breast feeding. (any woman becoming pregnant during the study will be withdrawn from the study.)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Investigational New Drugs | Use of
Item
the patient has used a clinical trial investigational drug within 1 month before the screening visit.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Exacerbation of asthma | Adrenal Cortex Hormones | Antibiotics | Lower respiratory tract infection
Item
the patient has an ongoing asthma exacerbation or has received ocs and/or antibiotics for a lower respiratory condition (proxy measure for identifying an asthma exacerbation and/or lower respiratory infection, suggestive of altered inspiratory capabilities) in the 2 weeks preceding visit
boolean
C0349790 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0003232 (UMLS CUI [3,1])
C0149725 (UMLS CUI [3,2])
Adrenal Cortex Hormones
Item
the patient is currently receiving any ocs (including long or short courses).
boolean
C0001617 (UMLS CUI [1])
chronic lower respiratory disease | Chronic Obstructive Airway Disease | Cystic Fibrosis | Lung Diseases, Interstitial | Bronchiectasis
Item
the patient has a significant chronic lower respiratory tract disease other than asthma eg chronic obstructive pulmonary disease (copd), cystic fibrosis or interstitial lung disease. conditions that are not predominant, such as minor degrees of bronchiectasis, are not a reason for exclusion.
boolean
C0348692 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0206062 (UMLS CUI [4])
C0006267 (UMLS CUI [5])
Hypersensitivity | Metered Dose Inhaler | Lactose | Milk Proteins
Item
the patient has a known allergy or severe sensitivity to the constituents of the study drugs (spiromax or turbohaler) eg, to lactose or to milk protein.
boolean
C0020517 (UMLS CUI [1,1])
C0993596 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0022949 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0026138 (UMLS CUI [3,2])
Exclusion Criteria | Other
Item
other criteria apply, please contact the investigator for additional information
boolean
C0680251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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