ID

42530

Description

A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02040779

Link

https://clinicaltrials.gov/show/NCT02040779

Keywords

  1. 8/18/21 8/18/21 -
Copyright Holder

Teva Branded Pharmaceutical Products R&D, Inc.

Uploaded on

August 18, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Persistent Asthma NCT02040779

Eligibility Persistent Asthma NCT02040779

Inclusion Criteria
Description

Inclusion Criteria

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

Persistent asthma | FEV 1 value predicted for age, height, sex, and race as per the national health | Nutrition examination survey (nhanes iii) reference hankinson et al 1999).

Data type

boolean

Alias
UMLS CUI [1,1]
C3266628
UMLS CUI [1,2]
C0730561
UMLS CUI [1,3]
C0001779
UMLS CUI [1,4]
C0005890
UMLS CUI [1,5]
C0079399
UMLS CUI [1,6]
C0034510
UMLS CUI [1,7]
C2825743
1) inhaled corticosteroids (icss) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (mdi) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (sabas) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (sv).
Description

Stable daily dose of inhaled corticosteroids fluticasone propionate via metered dose inhaler or equivalent for a minimum of 4 weeks | Stable daily dosage of non-corticosteroid therapy for a minimum of 4 weeks

Data type

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C0117996
UMLS CUI [1,3]
C2348070
UMLS CUI [1,4]
C0993596
UMLS CUI [1,5]
C1524031
UMLS CUI [1,6]
C0449238
UMLS CUI [2,1]
C2065041
UMLS CUI [2,2]
C0117996
UMLS CUI [2,3]
C2348070
UMLS CUI [2,4]
C0993596
UMLS CUI [2,5]
C0205163
UMLS CUI [2,6]
C1524031
UMLS CUI [2,7]
C0449238
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C1705847
UMLS CUI [3,4]
C2348070
UMLS CUI [3,5]
C1524031
UMLS CUI [3,6]
C0449238
reversibility of disease: the patient has demonstrated at least 15% 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 sv or on retesting. - other criteria apply, please contact the investigator for more information
Description

Increase of FEV1 after albuterol/salbutamol hydrofluoroalkane | Other inclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0001927
UMLS CUI [2,1]
C0748133
UMLS CUI [2,2]
C0205217
UMLS CUI [2,3]
C0001927
UMLS CUI [2,4]
C0205163
UMLS CUI [3,1]
C1512693
UMLS CUI [3,2]
C0205394
Exclusion Criteria
Description

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.
Description

History of life-threatening asthma | Intubation | Hypercapnea | Respiratory arrest | Hypoxic seizures

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C0262926
UMLS CUI [2]
C0021925
UMLS CUI [3]
C0020440
UMLS CUI [4]
C0162297
UMLS CUI [5]
C1843573
the patient is a pregnant or lactating female or plans to become pregnant.
Description

Pregnancy | Breast Feeding | Pregnancy planned

Data type

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.
Description

History of corticosteroid hypersensitivity | History of hypersensitivity of any component of an experimental drug | History of hypersensitivity of rescue remedy

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0020517
UMLS CUI [2,4]
C0262926
UMLS CUI [3,1]
C0884980
UMLS CUI [3,2]
C0020517
UMLS CUI [3,3]
C0262926
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). the patient may not have used tobacco products within the past year.
Description

History of a smoking status | Pack years | Absent recent use of tobacco products

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C1277691
UMLS CUI [3,1]
C0543414
UMLS CUI [3,2]
C0332185
UMLS CUI [3,3]
C0332197
the patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before sv, or has had any hospitalization for asthma within 2 months before sv.
Description

Recent asthma exacerbation requiring oral corticosteroids | Any hospitalization due to asthma recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0001617
UMLS CUI [1,5]
C1527415
UMLS CUI [1,6]
C0332185
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0004096
UMLS CUI [2,4]
C0332185
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.
Description

History of a clinically significant disease | Current clinically significant disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0521116
other criteria apply, please contact the investigator for more information
Description

Other exclusion criteria

Data type

boolean

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

Similar models

Eligibility Persistent Asthma NCT02040779

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Persistent asthma | FEV 1 value predicted for age, height, sex, and race as per the national health | Nutrition examination survey (nhanes iii) reference hankinson et al 1999).
Item
severity of disease: the patient has persistent asthma, with an forced expiratory volume in 1 second (fev1) 40%-85% of the value predicted for age, height, sex, and race as per the national health and nutrition examination survey (nhanes iii) reference values at screening visit (sv) (hankinson et al 1999).
boolean
C3266628 (UMLS CUI [1,1])
C0730561 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
C0005890 (UMLS CUI [1,4])
C0079399 (UMLS CUI [1,5])
C0034510 (UMLS CUI [1,6])
C2825743 (UMLS CUI [1,7])
Stable daily dose of inhaled corticosteroids fluticasone propionate via metered dose inhaler or equivalent for a minimum of 4 weeks | Stable daily dosage of non-corticosteroid therapy for a minimum of 4 weeks
Item
1) inhaled corticosteroids (icss) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (mdi) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (sabas) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (sv).
boolean
C2065041 (UMLS CUI [1,1])
C0117996 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0993596 (UMLS CUI [1,4])
C1524031 (UMLS CUI [1,5])
C0449238 (UMLS CUI [1,6])
C2065041 (UMLS CUI [2,1])
C0117996 (UMLS CUI [2,2])
C2348070 (UMLS CUI [2,3])
C0993596 (UMLS CUI [2,4])
C0205163 (UMLS CUI [2,5])
C1524031 (UMLS CUI [2,6])
C0449238 (UMLS CUI [2,7])
C0087111 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C1705847 (UMLS CUI [3,3])
C2348070 (UMLS CUI [3,4])
C1524031 (UMLS CUI [3,5])
C0449238 (UMLS CUI [3,6])
Increase of FEV1 after albuterol/salbutamol hydrofluoroalkane | Other inclusion criteria
Item
reversibility of disease: the patient has demonstrated at least 15% 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 sv or on retesting. - other criteria apply, please contact the investigator for more information
boolean
C0748133 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0001927 (UMLS CUI [1,3])
C0748133 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0001927 (UMLS CUI [2,3])
C0205163 (UMLS CUI [2,4])
C1512693 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
History of life-threatening asthma | Intubation | Hypercapnea | Respiratory arrest | Hypoxic 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
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
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 a pregnant or lactating female or plans to become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
History of corticosteroid hypersensitivity | History of hypersensitivity of any component of an experimental drug | History of hypersensitivity of rescue remedy
Item
the patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
boolean
C0001617 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,3])
C0262926 (UMLS CUI [2,4])
C0884980 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C0262926 (UMLS CUI [3,3])
History of a smoking status | Pack years | Absent recent use of tobacco products
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). the patient may not have used tobacco products within the past year.
boolean
C0543414 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277691 (UMLS CUI [2])
C0543414 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Recent asthma exacerbation requiring oral corticosteroids | Any hospitalization due to asthma recent
Item
the patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before sv, or has had any hospitalization for asthma within 2 months before sv.
boolean
C0349790 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0001617 (UMLS CUI [1,4])
C1527415 (UMLS CUI [1,5])
C0332185 (UMLS CUI [1,6])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0004096 (UMLS CUI [2,3])
C0332185 (UMLS CUI [2,4])
History of a clinically significant disease | Current clinically significant disease
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])
C0750502 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
Other exclusion criteria
Item
other criteria apply, please contact the investigator for more information
boolean
C0680251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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