ID

19731

Description

Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT00497523

Link

https://clinicaltrials.gov/show/NCT00497523

Keywords

Versions (1)
  1. 1/24/17 1/24/17 -
Uploaded on

January 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Bronchial Asthma NCT00497523

English

Eligibility Bronchial Asthma NCT00497523

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients will be enrolled into the 2-week placebo run-in period if they meet all the following criteria:
Description

Enrollment Run-in Period Placebo | criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C3274438
UMLS CUI [1,3]
C0032042
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
age ≥ 1 year and ≤ 4 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
at least 3 episodes of wheeze or asthma-like symptoms in the 6 months preceding the study entry.
Description

Wheeze Episode Quantity | Asthma-like Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0043144
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0877446
UMLS CUI [2,2]
C1457887
a cooperative attitude and ability to be trained to inhale correctly from the device and to complete the diary cards.
Description

Compliance behavior | Inhalation Device Use of Ability | Subject Diary Completion Ability

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C0021455
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0085732
UMLS CUI [3,1]
C3890583
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C0085732
written parental/guardian informed consent obtained.
Description

Informed Consent parent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
patients will be then randomised to the treatment period if they meet all the previous criteria plus:
Description

Randomization Therapeutic procedure Period | criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1948053
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
presence in at least 7 days out of the 14 days of the run-in period of at least one of the following symptoms: wheeze, cough or shortness of breath; or had required at least one dose of relief salbutamol.
Description

Wheeze | Cough | Dyspnea | Albuterol Dose Quantity Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0043144
UMLS CUI [2]
C0010200
UMLS CUI [3]
C0013404
UMLS CUI [4,1]
C0001927
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0686904
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of severe asthma exacerbation or exacerbations requiring hospitalisation in the previous 4 weeks.
Description

Exacerbation of asthma Severe | Exacerbation of asthma Requirement Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0349790
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0019993
symptomatic infection of the airways requiring treatment with antibiotics or antimycotics in the previous 4 weeks.
Description

Respiratory Tract Infections Symptomatic Requirement Antibiotics | Respiratory Tract Infections Symptomatic Requirement ANTIMYCOTICS

Data type

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0003232
UMLS CUI [2,1]
C0035243
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C3653762
treatment with inhaled steroids in the previous 4 weeks or oral steroids in the previous 8 weeks.
Description

inhaled steroids | Oral steroids

Data type

boolean

Alias
UMLS CUI [1]
C2065041
UMLS CUI [2]
C0419839
treatment with methyl-xantine derivatives in the previous 4 weeks.
Description

methylxanthine derivatives

Data type

boolean

Alias
UMLS CUI [1,1]
C0066447
UMLS CUI [1,2]
C0243072
treatment with long-acting β2-agonists in the previous 2 weeks.
Description

Adrenergic beta-2 Receptor Agonists

Data type

boolean

Alias
UMLS CUI [1]
C2936789
changes in asthma medications taken on regular basis in the previous 4 weeks.
Description

Asthma Pharmaceutical Preparations Change

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0392747
symptoms of asthma limited to seasonal allergen exposure.
Description

Seasonal asthma Symptoms Exposure to allergen

Data type

boolean

Alias
UMLS CUI [1,1]
C2919352
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0238614
history of clinically significant cardiac, renal, neurologic, hepatic, endocrine or pulmonary disease (except asthma), or laboratory testing abnormalities, whose sequelae and/or treatments can interfere with the results of the present study.
Description

Heart Disease Clinical Significance | Kidney Diseases | nervous system disorder | Liver diseases | Endocrine System Diseases | Lung diseases | Asthma | Laboratory test result abnormal Sequelae Interfere with research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0014130
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0004096
UMLS CUI [8,1]
C0438215
UMLS CUI [8,2]
C0243088
UMLS CUI [8,3]
C0521102
UMLS CUI [8,4]
C0683954
evidence of pulmonary malformations.
Description

Pulmonary malformation Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0235915
UMLS CUI [1,2]
C0332120
evidence of immunological deficiency (patients to be withdrawn if diagnosed during the study).
Description

Immunodeficiency Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C0332120
cancer or any other chronic disease with prognosis < 2 years.
Description

Malignant Neoplasm | Chronic disease Prognosis

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0033325
hypersensitivity to inhaled corticosteroids.
Description

Allergy to inhaled corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0571078
participation in another trial in the last 4 weeks.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Bronchial Asthma NCT00497523

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Enrollment Run-in Period Placebo | criteria Fulfill
Item
patients will be enrolled into the 2-week placebo run-in period if they meet all the following criteria:
boolean
C1516879 (UMLS CUI [1,1])
C3274438 (UMLS CUI [1,2])
C0032042 (UMLS CUI [1,3])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Age
Item
age ≥ 1 year and ≤ 4 years.
boolean
C0001779 (UMLS CUI [1])
Wheeze Episode Quantity | Asthma-like Symptoms
Item
at least 3 episodes of wheeze or asthma-like symptoms in the 6 months preceding the study entry.
boolean
C0043144 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0877446 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Compliance behavior | Inhalation Device Use of Ability | Subject Diary Completion Ability
Item
a cooperative attitude and ability to be trained to inhale correctly from the device and to complete the diary cards.
boolean
C1321605 (UMLS CUI [1])
C0021455 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C3890583 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0085732 (UMLS CUI [3,3])
Informed Consent parent | Informed Consent Guardian
Item
written parental/guardian informed consent obtained.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Randomization Therapeutic procedure Period | criteria Fulfill
Item
patients will be then randomised to the treatment period if they meet all the previous criteria plus:
boolean
C0034656 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Wheeze | Cough | Dyspnea | Albuterol Dose Quantity Patient need for
Item
presence in at least 7 days out of the 14 days of the run-in period of at least one of the following symptoms: wheeze, cough or shortness of breath; or had required at least one dose of relief salbutamol.
boolean
C0043144 (UMLS CUI [1])
C0010200 (UMLS CUI [2])
C0013404 (UMLS CUI [3])
C0001927 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0686904 (UMLS CUI [4,4])
Item Group
C0680251 (UMLS CUI)
Exacerbation of asthma Severe | Exacerbation of asthma Requirement Hospitalization
Item
history of severe asthma exacerbation or exacerbations requiring hospitalisation in the previous 4 weeks.
boolean
C0349790 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0349790 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0019993 (UMLS CUI [2,3])
Respiratory Tract Infections Symptomatic Requirement Antibiotics | Respiratory Tract Infections Symptomatic Requirement ANTIMYCOTICS
Item
symptomatic infection of the airways requiring treatment with antibiotics or antimycotics in the previous 4 weeks.
boolean
C0035243 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0003232 (UMLS CUI [1,4])
C0035243 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C3653762 (UMLS CUI [2,4])
inhaled steroids | Oral steroids
Item
treatment with inhaled steroids in the previous 4 weeks or oral steroids in the previous 8 weeks.
boolean
C2065041 (UMLS CUI [1])
C0419839 (UMLS CUI [2])
methylxanthine derivatives
Item
treatment with methyl-xantine derivatives in the previous 4 weeks.
boolean
C0066447 (UMLS CUI [1,1])
C0243072 (UMLS CUI [1,2])
Adrenergic beta-2 Receptor Agonists
Item
treatment with long-acting β2-agonists in the previous 2 weeks.
boolean
C2936789 (UMLS CUI [1])
Asthma Pharmaceutical Preparations Change
Item
changes in asthma medications taken on regular basis in the previous 4 weeks.
boolean
C0004096 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
Seasonal asthma Symptoms Exposure to allergen
Item
symptoms of asthma limited to seasonal allergen exposure.
boolean
C2919352 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0238614 (UMLS CUI [1,3])
Heart Disease Clinical Significance | Kidney Diseases | nervous system disorder | Liver diseases | Endocrine System Diseases | Lung diseases | Asthma | Laboratory test result abnormal Sequelae Interfere with research results
Item
history of clinically significant cardiac, renal, neurologic, hepatic, endocrine or pulmonary disease (except asthma), or laboratory testing abnormalities, whose sequelae and/or treatments can interfere with the results of the present study.
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0004096 (UMLS CUI [7])
C0438215 (UMLS CUI [8,1])
C0243088 (UMLS CUI [8,2])
C0521102 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
Pulmonary malformation Evidence of
Item
evidence of pulmonary malformations.
boolean
C0235915 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Immunodeficiency Evidence of
Item
evidence of immunological deficiency (patients to be withdrawn if diagnosed during the study).
boolean
C0021051 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Malignant Neoplasm | Chronic disease Prognosis
Item
cancer or any other chronic disease with prognosis < 2 years.
boolean
C0006826 (UMLS CUI [1])
C0008679 (UMLS CUI [2,1])
C0033325 (UMLS CUI [2,2])
Allergy to inhaled corticosteroids
Item
hypersensitivity to inhaled corticosteroids.
boolean
C0571078 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in another trial in the last 4 weeks.
boolean
C2348568 (UMLS CUI [1])
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