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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003745
Receipt No. R000004536
Scientific Title Clinical effects of budesonide/formoterol in patients with asthma
Date of disclosure of the study information 2010/06/14
Last modified on 2012/05/24

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Basic information
Public title Clinical effects of budesonide/formoterol in patients with asthma
Acronym Clinical effects of budesonide/formoterol in patients with asthma
Scientific Title Clinical effects of budesonide/formoterol in patients with asthma
Scientific Title:Acronym Clinical effects of budesonide/formoterol in patients with asthma
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of budesonide/formoterol on clinical index of asthma compared with budesonide
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Indices of chest CT
Key secondary outcomes Parameters of pulmonary function
PEF
Cell counts of induced sputum
Scores of quality of life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Symbicort treatment group
Symicort turbuhaler (60) 2 inhlation, twice daily
Treatment period 4 months
Interventions/Control_2 Budosonide treatment group
Budosonide turbuhaler (200) 2 inhlation, twice daily
Treatment period 4 months
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who have been not treated with ICS or oral corticosteroids within 2 months before the study
2. Patients who have been not treated with LABA within 1 months before the study
3. Patients have typical asthma symptoms as follows; cough, wheeze, dyspnea, nocturnal sleep disturbance
Key exclusion criteria 1. Patients who have any coexisting pulmonary diseases other than asthma
2. Pregnancy or lactation
3. Patients have hypersensitivity to symbicort or budesonide
4. Patiesnts judged to be unsuitable by the doctors
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Hoshino
Organization Atami Hospital
International University of Health and Welfare
Division name Department of Respiratory Medicine
Zip code
Address 13-1 Higashikaigan-cho, Atami, Shizuoka
TEL 0557-81-9171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Hoshino
Organization Atami Hospital International University of Health and Welfare
Division name Department of Respiratory Medicine
Zip code
Address 13-1 Higashikaigan-cho, Atami, Shizuoka
TEL 0557-81-9171
Homepage URL
Email

Sponsor
Institute Atami Hospital International University of Health and Welfare
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国際医療福祉大学熱海病院(静岡県)
Atami Hospital International University of Health and Welfare

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 04 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 13 Day
Last modified on
2012 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004536

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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