ID

14303

Beskrivning

Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation; ODM derived from: https://clinicaltrials.gov/show/NCT02210806

Länk

https://clinicaltrials.gov/show/NCT02210806

Nyckelord

Versioner (1)
  1. 2016-04-08 2016-04-08 -
Uppladdad den

8 april 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Asthma NCT02210806

Engelsk

Eligibility Asthma NCT02210806

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02210806
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
generally healthy, male and female adults, 18-55 years of age at screening
Beskrivning

Age | Well adult

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0686750
with mild-to-moderate persistent asthma for at least 6 months prior to screening, and having used inhaled β-agonist(s) for asthma control
Beskrivning

Mild persistent asthma | Moderate persistent asthma | Adrenergic beta-Agonists

Datatyp

boolean

Alias
UMLS CUI [1]
C1960046
UMLS CUI [2]
C1960047
UMLS CUI [3]
C0001644
demonstrating a screening baseline fev1 at 50.0 - 85.0 percent of predicted normal
Beskrivning

FEV1

Datatyp

boolean

Alias
UMLS CUI [1]
C0748133
demonstrating a ≥ 15.0% airway reversibility in fev1 within 30 min after inhaling 2 actuations of proventil® mdi (180 mcg) at screening
Beskrivning

airway disease Reversibility | FEV1 | Proventil | Metered Dose Inhaler

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0699949
UMLS CUI [1,2]
C0449261
UMLS CUI [2]
C0748133
UMLS CUI [3]
C0699770
UMLS CUI [4]
C0993596
demonstrating peak inspiratory flow rate (pif) within 80-150 l/min (after training), for at least 2 times consecutively with a maximum of 5 attempts
Beskrivning

Peak inspiratory flow rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0429742
demonstrating proficiency in the use of a dpi and an mdi after training
Beskrivning

Use of Dry Powder Inhaler (device) | Use of Metered Dose Inhaler

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1967611
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0993596
females of child-bearing potential must be non-pregnant, non-lactating; both males and females enrolled into the study must agree to practice a clinically acceptable form of birth control (including but not limited to, abstinence, double barrier, etc)
Beskrivning

Childbearing Potential | Not pregnant (finding) | Breast Feeding | Contraceptive methods | Sexual Abstinence | Contraception, Barrier

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0232973
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0004764
having properly consented to participate in the trial
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
a smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to screening
Beskrivning

smoking cigarettes: ____ pack-years history | Former smoker

Datatyp

boolean

Alias
UMLS CUI [1]
C2230126
UMLS CUI [2]
C0337671
upper respiratory tract infections or lower respiratory tract infection within 6 weeks, prior to screening
Beskrivning

Upper Respiratory Infections | Lower respiratory tract infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0041912
UMLS CUI [2]
C0149725
asthma exacerbations that required emergency care or hospitalized treatment, within 4 weeks prior to screening
Beskrivning

Exacerbation of asthma | Emergency Care | Hospitalization

Datatyp

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C1527398
UMLS CUI [3]
C0019993
any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma
Beskrivning

Respiration Disorders Affecting Investigational New Drugs | Cystic Fibrosis | Bronchiectasis | Tuberculosis | Pulmonary Emphysema

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0013230
UMLS CUI [2]
C0010674
UMLS CUI [3]
C0006267
UMLS CUI [4]
C0041296
UMLS CUI [5]
C0034067
concurrent clinically significant cardiovascular (e.g. hypertension and tachyarrhythmia and bradyarrhythmia), hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
Beskrivning

Cardiovascular Diseases | Hypertensive disease | Tachyarrhythmia | Bradyarrhythmia | Hematological Disease | Kidney Diseases | nervous system disorder | Liver diseases | Endocrine System Diseases | Mental disorders | Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0080203
UMLS CUI [4]
C0079035
UMLS CUI [5]
C0018939
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0023895
UMLS CUI [9]
C0014130
UMLS CUI [10]
C0004936
UMLS CUI [11]
C0006826
known intolerance or hypersensitivity to any of the ingredients of the study drug dpi or proventil® hfa mdi (i.e., albuterol, sulfate, lactose, milk protein, hfa-134a, oleic acid, and ethanol)
Beskrivning

Hypersensitivity Investigational New Drugs | Proventil HFA | Albuterol | Sulfates, Inorganic | Lactose | Milk Proteins | HFA 134a | Oleic Acid | Ethanol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0722880
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0001927
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0038720
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0022949
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0026138
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0298501
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0028928
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0001962
baseline ecg at screening or visit 1 showing any single or multiple premature ventricular contractions (pvc)
Beskrivning

Unifocal PVCs | Multifocal PVCs | Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0264902
UMLS CUI [2]
C0264903
UMLS CUI [3]
C1623258
baseline ecg at screening or visit 1 with a confirmed (through performing a second ecg) qtc reading greater than 450ms
Beskrivning

QTc | Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0860814
UMLS CUI [2]
C1623258
use of prohibited drugs or failure to observe the drug washout restrictions
Beskrivning

Pharmaceutical Preparations no permission

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3242263
having been on other clinical drug/device studies in the last 30 days prior to screening.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Asthma NCT02210806

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02210806
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Well adult
Item
generally healthy, male and female adults, 18-55 years of age at screening
boolean
C0001779 (UMLS CUI [1])
C0686750 (UMLS CUI [2])
Mild persistent asthma | Moderate persistent asthma | Adrenergic beta-Agonists
Item
with mild-to-moderate persistent asthma for at least 6 months prior to screening, and having used inhaled β-agonist(s) for asthma control
boolean
C1960046 (UMLS CUI [1])
C1960047 (UMLS CUI [2])
C0001644 (UMLS CUI [3])
FEV1
Item
demonstrating a screening baseline fev1 at 50.0 - 85.0 percent of predicted normal
boolean
C0748133 (UMLS CUI [1])
airway disease Reversibility | FEV1 | Proventil | Metered Dose Inhaler
Item
demonstrating a ≥ 15.0% airway reversibility in fev1 within 30 min after inhaling 2 actuations of proventil® mdi (180 mcg) at screening
boolean
C0699949 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2])
C0699770 (UMLS CUI [3])
C0993596 (UMLS CUI [4])
Peak inspiratory flow rate
Item
demonstrating peak inspiratory flow rate (pif) within 80-150 l/min (after training), for at least 2 times consecutively with a maximum of 5 attempts
boolean
C0429742 (UMLS CUI [1])
Use of Dry Powder Inhaler (device) | Use of Metered Dose Inhaler
Item
demonstrating proficiency in the use of a dpi and an mdi after training
boolean
C1524063 (UMLS CUI [1,1])
C1967611 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0993596 (UMLS CUI [2,2])
Childbearing Potential | Not pregnant (finding) | Breast Feeding | Contraceptive methods | Sexual Abstinence | Contraception, Barrier
Item
females of child-bearing potential must be non-pregnant, non-lactating; both males and females enrolled into the study must agree to practice a clinically acceptable form of birth control (including but not limited to, abstinence, double barrier, etc)
boolean
C3831118 (UMLS CUI [1])
C0232973 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
Informed consent
Item
having properly consented to participate in the trial
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
smoking cigarettes: ____ pack-years history | Former smoker
Item
a smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to screening
boolean
C2230126 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
Upper Respiratory Infections | Lower respiratory tract infection
Item
upper respiratory tract infections or lower respiratory tract infection within 6 weeks, prior to screening
boolean
C0041912 (UMLS CUI [1])
C0149725 (UMLS CUI [2])
Exacerbation of asthma | Emergency Care | Hospitalization
Item
asthma exacerbations that required emergency care or hospitalized treatment, within 4 weeks prior to screening
boolean
C0349790 (UMLS CUI [1])
C1527398 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
Respiration Disorders Affecting Investigational New Drugs | Cystic Fibrosis | Bronchiectasis | Tuberculosis | Pulmonary Emphysema
Item
any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma
boolean
C0035204 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0010674 (UMLS CUI [2])
C0006267 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
C0034067 (UMLS CUI [5])
Cardiovascular Diseases | Hypertensive disease | Tachyarrhythmia | Bradyarrhythmia | Hematological Disease | Kidney Diseases | nervous system disorder | Liver diseases | Endocrine System Diseases | Mental disorders | Malignant Neoplasms
Item
concurrent clinically significant cardiovascular (e.g. hypertension and tachyarrhythmia and bradyarrhythmia), hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
boolean
C0007222 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0080203 (UMLS CUI [3])
C0079035 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0004936 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
Hypersensitivity Investigational New Drugs | Proventil HFA | Albuterol | Sulfates, Inorganic | Lactose | Milk Proteins | HFA 134a | Oleic Acid | Ethanol
Item
known intolerance or hypersensitivity to any of the ingredients of the study drug dpi or proventil® hfa mdi (i.e., albuterol, sulfate, lactose, milk protein, hfa-134a, oleic acid, and ethanol)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0722880 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0001927 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0038720 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0022949 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0026138 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0298501 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0028928 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0001962 (UMLS CUI [9,2])
Unifocal PVCs | Multifocal PVCs | Electrocardiography
Item
baseline ecg at screening or visit 1 showing any single or multiple premature ventricular contractions (pvc)
boolean
C0264902 (UMLS CUI [1])
C0264903 (UMLS CUI [2])
C1623258 (UMLS CUI [3])
QTc | Electrocardiography
Item
baseline ecg at screening or visit 1 with a confirmed (through performing a second ecg) qtc reading greater than 450ms
boolean
C0860814 (UMLS CUI [1])
C1623258 (UMLS CUI [2])
Pharmaceutical Preparations no permission
Item
use of prohibited drugs or failure to observe the drug washout restrictions
boolean
C0013227 (UMLS CUI [1,1])
C3242263 (UMLS CUI [1,2])
Study Subject Participation Status
Item
having been on other clinical drug/device studies in the last 30 days prior to screening.
boolean
C2348568 (UMLS CUI [1])
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