ID

14489

Description

4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00634517

Link

https://clinicaltrials.gov/show/NCT00634517

Keywords

Versions (1)
  1. 4/18/16 4/18/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 18, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00634517

English

Eligibility Asthma NCT00634517

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00634517
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. generally healthy.
Description

healthy

Data type

boolean

Alias
UMLS CUI [1]
C1708335
2. male and female mild-to-moderate asthma patients.
Description

mild to moderate asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C1960046
UMLS CUI [1,2]
C1960047
3. aged 4 - 11 yr (upon screening).
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. female patients must be premenarchal upon visit-1, and those who become menarchal during the study must use an accepted method of contraception including abstinence.
Description

premenarchal

Data type

boolean

Alias
UMLS CUI [1]
C2609149
UMLS CUI [2]
C0700589
5. a documented history of asthma, for at-least 6-months prior to screening, requiring inhaled b-adrenergic agonists, with or without inhaled corticosteroids for asthma symptom control.
Description

asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C2936789
UMLS CUI [2,2]
C0001559
UMLS CUI [3]
C2065041
6. satisfying asthma stability criterion, defined as no changes in asthma therapy and no asthma-related hospitalization or emergency room visits, over the 4 weeks prior to screening.
Description

stable asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205360
7. being able to withhold treatment with inhaled bronchodilators and/or restricted medications for the minimum washout periods indicated in appendix ii, for the purpose of conducting clinical visits.
Description

withhold treatment with inhaled bronchodilators

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C0006280
UMLS CUI [2,2]
C0001559
8. having a baseline forced expiratory volume in 1 second (fev1), that is 50.0-100.0% of predicted values at the screening (screening baseline fev1).
Description

fev1

Data type

boolean

Alias
UMLS CUI [1]
C0748133
9. demonstrating a greater than or equal to 12.0% reversibility in the reversibility test, at 30 min after inhaling 2-4 puffs (180-360 mcg) of ventolin-hfa.
Description

reversibility test fev1

Data type

boolean

Alias
UMLS CUI [1,1]
C3548479
UMLS CUI [1,2]
C0748133
10. demonstrating correct use of metered-dose inhaler (mdis), and acceptable performance in the fev1 measurements.
Description

metered-dose inhaler

Data type

boolean

Alias
UMLS CUI [1]
C0993596
UMLS CUI [2]
C1321605
UMLS CUI [3]
C0748133
11. has properly consented, with a parent or a legal guardian, to participate in this study.
Description

consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any current or past significant medical conditions that, according to the investigator, might affect pharmacodynamic response to the study drugs, such as significant systemic or respiratory diseases (e.g., cystic fibrosis, bronchiectasis, emphysema, nonreversible pulmonary diseases), other than asthma.
Description

comorbidity limiting study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
2. concurrent clinically significant cardiovascular, hematological, renal, neurological, hepatic, and endocrine disorders, or psychiatric diseases.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
3. known intolerance or hypersensitivity to any component of the mdi formulation (e.g., albuterol, hfa-134a, oleic acid, ethanol).
Description

hypersensitivity to any component of the mdi formulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0993596
4. recent upper (within 2 weeks) or lower (within 4 weeks) respiratory tract infection before screening.
Description

respiratory tract infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0040223
5. recent (within 4 weeks) use of systemic (or oral) corticosteroids and b-adrenergic bronchodilators; or recent (within 2 weeks) use of monoamine oxidase inhibitors (maois), tricyclic antidepressants (tcas), or b-blockers; before the screening.
Description

systemic steroids b-adrenergic bronchodilator monoamine oxidase inhibitors (maois), tricyclic antidepressants (tcas), or b-blockers

Data type

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0001644
UMLS CUI [2,2]
C0006280
UMLS CUI [3]
C0026457
UMLS CUI [4]
C0003290
UMLS CUI [5]
C0304516
6. having been on other investigational drug/device studies in the last 30 days prior to screening.
Description

participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
7. known or reasonably suspected alcohol/drug abuses.
Description

alcohol/drug abuses

Data type

boolean

Alias
UMLS CUI [1]
C0038586
8. having smoked within the last 12 months.
Description

smoking history

Data type

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C0040223
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Similar models

Eligibility Asthma NCT00634517

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00634517
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
healthy
Item
1. generally healthy.
boolean
C1708335 (UMLS CUI [1])
mild to moderate asthma
Item
2. male and female mild-to-moderate asthma patients.
boolean
C1960046 (UMLS CUI [1,1])
C1960047 (UMLS CUI [1,2])
age
Item
3. aged 4 - 11 yr (upon screening).
boolean
C0001779 (UMLS CUI [1])
premenarchal
Item
4. female patients must be premenarchal upon visit-1, and those who become menarchal during the study must use an accepted method of contraception including abstinence.
boolean
C2609149 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
asthma
Item
5. a documented history of asthma, for at-least 6-months prior to screening, requiring inhaled b-adrenergic agonists, with or without inhaled corticosteroids for asthma symptom control.
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C2936789 (UMLS CUI [2,1])
C0001559 (UMLS CUI [2,2])
C2065041 (UMLS CUI [3])
stable asthma
Item
6. satisfying asthma stability criterion, defined as no changes in asthma therapy and no asthma-related hospitalization or emergency room visits, over the 4 weeks prior to screening.
boolean
C0004096 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
withhold treatment with inhaled bronchodilators
Item
7. being able to withhold treatment with inhaled bronchodilators and/or restricted medications for the minimum washout periods indicated in appendix ii, for the purpose of conducting clinical visits.
boolean
C1321605 (UMLS CUI [1])
C0006280 (UMLS CUI [2,1])
C0001559 (UMLS CUI [2,2])
fev1
Item
8. having a baseline forced expiratory volume in 1 second (fev1), that is 50.0-100.0% of predicted values at the screening (screening baseline fev1).
boolean
C0748133 (UMLS CUI [1])
reversibility test fev1
Item
9. demonstrating a greater than or equal to 12.0% reversibility in the reversibility test, at 30 min after inhaling 2-4 puffs (180-360 mcg) of ventolin-hfa.
boolean
C3548479 (UMLS CUI [1,1])
C0748133 (UMLS CUI [1,2])
metered-dose inhaler
Item
10. demonstrating correct use of metered-dose inhaler (mdis), and acceptable performance in the fev1 measurements.
boolean
C0993596 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C0748133 (UMLS CUI [3])
consent
Item
11. has properly consented, with a parent or a legal guardian, to participate in this study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity limiting study protocol
Item
1. any current or past significant medical conditions that, according to the investigator, might affect pharmacodynamic response to the study drugs, such as significant systemic or respiratory diseases (e.g., cystic fibrosis, bronchiectasis, emphysema, nonreversible pulmonary diseases), other than asthma.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
comorbidity
Item
2. concurrent clinically significant cardiovascular, hematological, renal, neurological, hepatic, and endocrine disorders, or psychiatric diseases.
boolean
C0009488 (UMLS CUI [1])
hypersensitivity to any component of the mdi formulation
Item
3. known intolerance or hypersensitivity to any component of the mdi formulation (e.g., albuterol, hfa-134a, oleic acid, ethanol).
boolean
C0020517 (UMLS CUI [1,1])
C0993596 (UMLS CUI [1,2])
respiratory tract infection
Item
4. recent upper (within 2 weeks) or lower (within 4 weeks) respiratory tract infection before screening.
boolean
C0035243 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
systemic steroids b-adrenergic bronchodilator monoamine oxidase inhibitors (maois), tricyclic antidepressants (tcas), or b-blockers
Item
5. recent (within 4 weeks) use of systemic (or oral) corticosteroids and b-adrenergic bronchodilators; or recent (within 2 weeks) use of monoamine oxidase inhibitors (maois), tricyclic antidepressants (tcas), or b-blockers; before the screening.
boolean
C2825233 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0001644 (UMLS CUI [2,1])
C0006280 (UMLS CUI [2,2])
C0026457 (UMLS CUI [3])
C0003290 (UMLS CUI [4])
C0304516 (UMLS CUI [5])
participation status
Item
6. having been on other investigational drug/device studies in the last 30 days prior to screening.
boolean
C2348568 (UMLS CUI [1])
alcohol/drug abuses
Item
7. known or reasonably suspected alcohol/drug abuses.
boolean
C0038586 (UMLS CUI [1])
smoking history
Item
8. having smoked within the last 12 months.
boolean
C1519384 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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