ID

44704

Description

MGR001 / Advair Diskus Local Equivalence Study in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02245672

Link

https://clinicaltrials.gov/show/NCT02245672

Keywords

Versions (2)
  1. 4/11/16 4/11/16 -
  2. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Asthma NCT02245672

English

Eligibility Asthma NCT02245672

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02245672
Criteria
Description

Criteria

male or female subjects aged ≥18 years. females may be of either childbearing or non-childbearing potential
Description

Age | Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3831118
physician diagnosed history of asthma for at least 12 weeks prior to screening
Description

Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
pre-bronchodilator fev1 60-85% at screening and other specified visits
Description

FEV1 pre bronchodilator

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599602
post-bronchodilator reversibility >/=12%
Description

post bronchodilator disease reversibility

Data type

boolean

Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C0679253
non-smokers and prior smokers with no history of smoking within the past 12 months prior to screening and a total smoking history of ≤10 pack-years
Description

Non-smoker | Former smoker | smoking cigarettes: ____ pack-years history

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0337671
UMLS CUI [3]
C2230126
subjects able to discontinue asthma medications for the duration of the study and be maintained using albuterol as required
Description

Ability Medication stopped Asthma | Albuterol

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1273478
UMLS CUI [1,3]
C0004096
UMLS CUI [2]
C0001927
body mass index between 18-40 kg/m2 inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
key exclusion criteria include:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
presence or recent history of any other active, severe, progressive, and/or uncontrolled clinical disease, eg, poorly controlled type 1 or 2 diabetes, seizure disorder or epilepsy, cerebrovascular accident, significant cardiac conduction abnormalities
Description

Comorbidity | Diabetes Mellitus, Insulin-Dependent Poorly controlled | Diabetes Mellitus, Non-Insulin-Dependent Poorly controlled | Epilepsy | Cerebrovascular accident | Abnormal cardiac conduction

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C3853134
UMLS CUI [4]
C0014544
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0232219
respiratory conditions other than asthma and allergic rhinitis, including but not limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive pulmonary disease, bronchiectasis, churg-strauss disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis
Description

Respiration Disorders | Asthma | Allergic rhinitis | Nasal Polyps | Chronic sinusitis | Chronic Obstructive Airway Disease | Bronchiectasis | Churg-Strauss Syndrome | Lung excision | Pulmonary Fibrosis | Pulmonary Hypertension | Cystic Fibrosis | Sarcoidosis

Data type

boolean

Alias
UMLS CUI [1]
C0035204
UMLS CUI [2]
C0004096
UMLS CUI [3]
C2607914
UMLS CUI [4]
C0027430
UMLS CUI [5]
C0149516
UMLS CUI [6]
C0024117
UMLS CUI [7]
C0006267
UMLS CUI [8]
C0008728
UMLS CUI [9]
C0396565
UMLS CUI [10]
C0034069
UMLS CUI [11]
C0020542
UMLS CUI [12]
C0010674
UMLS CUI [13]
C0036202
history of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s)
Description

Asthma Life Threatening | Episode of Asthma | Intubation | Hypercapnia | Respiratory arrest | Hypoxic convulsions | Syncopal Episode Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0004096
UMLS CUI [3]
C0021925
UMLS CUI [4]
C0020440
UMLS CUI [5]
C0162297
UMLS CUI [6]
C1843573
UMLS CUI [7,1]
C0751534
UMLS CUI [7,2]
C0004096
in patient hospitalization (not including er visits) for an asthma exacerbation within the past year or during the run in period
Description

Exacerbation of asthma | Hospitalization | Emergency room admission

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0019993
UMLS CUI [3]
C0583237
an asthma exacerbation requiring change in asthma therapy or oral/iv corticosteroids in the 3 months prior to screening
Description

Exacerbation of asthma | Therapy change | Adrenal Cortex Hormones | Intravenous steroid injection

Data type

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C3665894
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0563322
history of seasonally unstable asthma where the season will coincide with the subject's participation in the study
Description

Unstable status Asthma Seasonal asthma | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C2919352
UMLS CUI [2]
C2348568
use of prescription or non-prescription drugs, including beta blockers, tricyclic antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines, monoamine oxidase inhibitors, etc
Description

Pharmaceutical Preparations | Adrenergic beta-Antagonists | Tricyclic Antidepressive Agents | Decongestants | Benzodiazepines | Digitalis preparation | Phenothiazines | Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0001645
UMLS CUI [3]
C0003290
UMLS CUI [4]
C0282374
UMLS CUI [5]
C0005064
UMLS CUI [6]
C0304520
UMLS CUI [7]
C0031436
UMLS CUI [8]
C0026457
suspected hypersensitivity to the study drugs (including lactose) or severe milk protein allergy
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Lactose | Hypersensitivity Milk Proteins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0022949
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0026138
clinically significant abnormalities in the screening ecg
Description

ECG abnormality

Data type

boolean

Alias
UMLS CUI [1]
C0522055
evidence of alcohol or drug abuse or dependency within 6 months prior to screening
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
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Similar models

Eligibility Asthma NCT02245672

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02245672
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age | Childbearing Potential
Item
male or female subjects aged ≥18 years. females may be of either childbearing or non-childbearing potential
boolean
C0001779 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Asthma
Item
physician diagnosed history of asthma for at least 12 weeks prior to screening
boolean
C0004096 (UMLS CUI [1])
FEV1 pre bronchodilator
Item
pre-bronchodilator fev1 60-85% at screening and other specified visits
boolean
C0748133 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
post bronchodilator disease reversibility
Item
post-bronchodilator reversibility >/=12%
boolean
C2599594 (UMLS CUI [1,1])
C0679253 (UMLS CUI [1,2])
Non-smoker | Former smoker | smoking cigarettes: ____ pack-years history
Item
non-smokers and prior smokers with no history of smoking within the past 12 months prior to screening and a total smoking history of ≤10 pack-years
boolean
C0337672 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
C2230126 (UMLS CUI [3])
Ability Medication stopped Asthma | Albuterol
Item
subjects able to discontinue asthma medications for the duration of the study and be maintained using albuterol as required
boolean
C0085732 (UMLS CUI [1,1])
C1273478 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
C0001927 (UMLS CUI [2])
Body mass index
Item
body mass index between 18-40 kg/m2 inclusive
boolean
C1305855 (UMLS CUI [1])
Exclusion Criteria
Item
key exclusion criteria include:
boolean
C0680251 (UMLS CUI [1])
Comorbidity | Diabetes Mellitus, Insulin-Dependent Poorly controlled | Diabetes Mellitus, Non-Insulin-Dependent Poorly controlled | Epilepsy | Cerebrovascular accident | Abnormal cardiac conduction
Item
presence or recent history of any other active, severe, progressive, and/or uncontrolled clinical disease, eg, poorly controlled type 1 or 2 diabetes, seizure disorder or epilepsy, cerebrovascular accident, significant cardiac conduction abnormalities
boolean
C0009488 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0014544 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0232219 (UMLS CUI [6])
Respiration Disorders | Asthma | Allergic rhinitis | Nasal Polyps | Chronic sinusitis | Chronic Obstructive Airway Disease | Bronchiectasis | Churg-Strauss Syndrome | Lung excision | Pulmonary Fibrosis | Pulmonary Hypertension | Cystic Fibrosis | Sarcoidosis
Item
respiratory conditions other than asthma and allergic rhinitis, including but not limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive pulmonary disease, bronchiectasis, churg-strauss disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis
boolean
C0035204 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C2607914 (UMLS CUI [3])
C0027430 (UMLS CUI [4])
C0149516 (UMLS CUI [5])
C0024117 (UMLS CUI [6])
C0006267 (UMLS CUI [7])
C0008728 (UMLS CUI [8])
C0396565 (UMLS CUI [9])
C0034069 (UMLS CUI [10])
C0020542 (UMLS CUI [11])
C0010674 (UMLS CUI [12])
C0036202 (UMLS CUI [13])
Asthma Life Threatening | Episode of Asthma | Intubation | Hypercapnia | Respiratory arrest | Hypoxic convulsions | Syncopal Episode Asthma
Item
history of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s)
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0021925 (UMLS CUI [3])
C0020440 (UMLS CUI [4])
C0162297 (UMLS CUI [5])
C1843573 (UMLS CUI [6])
C0751534 (UMLS CUI [7,1])
C0004096 (UMLS CUI [7,2])
Exacerbation of asthma | Hospitalization | Emergency room admission
Item
in patient hospitalization (not including er visits) for an asthma exacerbation within the past year or during the run in period
boolean
C0349790 (UMLS CUI [1])
C0019993 (UMLS CUI [2])
C0583237 (UMLS CUI [3])
Exacerbation of asthma | Therapy change | Adrenal Cortex Hormones | Intravenous steroid injection
Item
an asthma exacerbation requiring change in asthma therapy or oral/iv corticosteroids in the 3 months prior to screening
boolean
C0349790 (UMLS CUI [1])
C3665894 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0563322 (UMLS CUI [4])
Unstable status Asthma Seasonal asthma | Study Subject Participation Status
Item
history of seasonally unstable asthma where the season will coincide with the subject's participation in the study
boolean
C0443343 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C2919352 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2])
Pharmaceutical Preparations | Adrenergic beta-Antagonists | Tricyclic Antidepressive Agents | Decongestants | Benzodiazepines | Digitalis preparation | Phenothiazines | Monoamine Oxidase Inhibitors
Item
use of prescription or non-prescription drugs, including beta blockers, tricyclic antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines, monoamine oxidase inhibitors, etc
boolean
C0013227 (UMLS CUI [1])
C0001645 (UMLS CUI [2])
C0003290 (UMLS CUI [3])
C0282374 (UMLS CUI [4])
C0005064 (UMLS CUI [5])
C0304520 (UMLS CUI [6])
C0031436 (UMLS CUI [7])
C0026457 (UMLS CUI [8])
Hypersensitivity Investigational New Drugs | Hypersensitivity Lactose | Hypersensitivity Milk Proteins
Item
suspected hypersensitivity to the study drugs (including lactose) or severe milk protein allergy
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0022949 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0026138 (UMLS CUI [3,2])
ECG abnormality
Item
clinically significant abnormalities in the screening ecg
boolean
C0522055 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence
Item
evidence of alcohol or drug abuse or dependency within 6 months prior to screening
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
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