UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003492 |
|---|---|
| Receipt number | R000004231 |
| Scientific Title | Efficacy and safety of regular treatment with procaterol and budesonide inhalation suspension for young children with moderate persistent asthma. |
| Date of disclosure of the study information | 2010/04/14 |
| Last modified on | 2014/10/14 10:28:16 |
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Basic information
Public title
Efficacy and safety of regular treatment with procaterol and budesonide inhalation suspension for young children with moderate persistent asthma.
Acronym
Budesonide + Procaterol Inhalation Therapy Study (BUPIT study)
Scientific Title
Efficacy and safety of regular treatment with procaterol and budesonide inhalation suspension for young children with moderate persistent asthma.
Scientific Title:Acronym
Budesonide + Procaterol Inhalation Therapy Study (BUPIT study)
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of regular treatment with procaterol and budesonide inhalation suspension for young children with moderate persistent asthma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Symptom free days (Sympton is cough and wheezing and dyspnea and sleep disturbance)
Key secondary outcomes
1.Score of symptom (base on asthma diary)
2.Frequency of inhaled short acting beta 2 agonist (SABA) use
3.Unscheduled hospital visits and emergency room visits because of asthma exacerbation
4.Count of blood eosinophil at baseline and end of phase 1 (end of phase 2,if possible)
5.Level of blood serum cortisol at baseline and end of phase 1 (end of phase 2,if possible)
6.QOL test at baseline and end of phase 1 (end of phase 2,if possible)
7.exhaled nitric oxide (only the child can be examined)
8.PEFR:morning and evening (only the child can be examined)
9.Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GROUP B + P (budesonide + procaterol)
Phase 1: 4 weeks
Inhalation of the mixture of procaterol(0.3ml for >15kg, 0.15ml for <15kg) and budesonide inhalation suspension(0.25mg), twice a day, using jet nebulizer (PARI TurboBOY N,PALI LC Plus Nebulizer)
Phase 2: 4 weeks after phase 1
Inhalation of budesonide inhalation suspension(0.25mg), twice a day, using jet nebulizer (PARI TurboBOY N,PALI LC Plus Nebulizer)
Interventions/Control_2
GROUP B (budesonide)
Phase 1: 4 weeks
Budesonide inhalation suspension (0.25 mg), twice a day, using jet nebulizer (PARI TurboBOY N,PALI LC Plus Nebulizer)
Phase 2: 4 weeks after phase 1
Continue method of Phase 1
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | months-old | <= |
Age-upper limit
| 60 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1.Children with persistent asthma
-Age : children over six months under five years of age
-Severity : moderate according to the criteria of JPGL 2008
2.Children who (whose parents) have given informed consent for participation in the present study.
Key exclusion criteria
1.Patients who have an event listed below within a month
a)Respiratory infection disease that required hospitalization
b)Administration of systemic corticosteroids
2.Recieving regular use of inhaled corticosteroids or beta 2 agonists in the previous 3 months
3.Patients who have severe chronic diseases
4.Patients who have chronic low airway diseases other than bronchial asthma
5.Any other children considered by the attending physicians as inappropriate for participation in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Adachi |
Organization
University of Toyama, Faculty of Medicine
Division name
Department of Pediatrics
Zip code
Address
2630 Sugitani,Toyama 930-0194,Japan
TEL
076-434-7313
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Adachi |
Organization
University of Toyama, Faculty of Medicine
Division name
Department of Pediatrics
Zip code
Address
2630 Sugitani,Toyama 930-0194,Japan
TEL
076-434-7313
Homepage URL
Sponsor or person
Institute
University of Toyama, Faculty of Medicine, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Pediatric Allergy and Clinical Immunology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
富山大学医学部小児科（富山県）
住友病院小児科（大阪府）
千葉大学大学院医学研究院小児病態学（千葉県）
東海大学医学部専門診療学系小児科学（神奈川）
大分大学医学部地域医療・小児科分野（大分県）
大垣市民病院小児科（岐阜県）
大阪府立呼吸器アレルギー医療センター小児科（大阪府）
大館市立総合病院小児科（秋田県）
君津中央病院小児科（千葉県）
黒部市民病院小児科（富山県）
国立病院機構福山医療センター小児科（広島県）
国立病院機構横浜医療センター小児科（神奈川県）
千葉県こども病院アレルギー科（千葉県）
筑波メディカルセンター病院小児科（茨城県）
獨協医科大学小児科（栃木県）
新潟県立吉田病院小児科（新潟県）
にしかわクリニック（香川県）
にしかわこどもクリニック（大阪府）
むらかみ小児科医院（富山県）
埼玉医科大学小児科（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 14 | Day |
Last modified on
| 2014 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004231
