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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010333
Receipt No. R000012095
Scientific Title Study of step-down therapy from formoterol/budesonide combinations in patients with asthma
Date of disclosure of the study information 2013/03/27
Last modified on 2013/09/27

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Basic information
Public title Study of step-down therapy from formoterol/budesonide combinations in patients with asthma
Acronym Step-down therapy from formoterol/budesonide combinations
Scientific Title Study of step-down therapy from formoterol/budesonide combinations in patients with asthma
Scientific Title:Acronym Step-down therapy from formoterol/budesonide combinations
Region
Japan

Condition
Condition Asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the efficacy and safety of the step-down therapy in patients with bronchial asthma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Asthma attack during the treatment period
Key secondary outcomes Lung function during the treatment period
QOL score during the treatment period
FeNO during the treatment period
Adverse events during the treatment period

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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switch from budesonide/formoterol (Symbicort)160/4.5ug two inhalation twice daily to one inhalation twice daily for 12 weeks
Interventions/Control_2 Switch from budesonide/formoterol (Symbicort)160/4.5ug two inhalation twice daily to budesonide (Pulmicort) 200ug two inhalation twice daily for 12 weeks
Interventions/Control_3 Switch from budesonide/formoterol (Symbicort)160/4.5ug two inhalation twice daily to mometasone(asmanex) 200ug one inhalation twice daily for 12 weeks
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Ability and willingness to provide informed consent
Budesonide/formoterol (Symbicort) 160/4.5ug two inhalation twice daily at constant dose for 2 months
Achieve good control of the GINA criteria
Key exclusion criteria History of presence of lung, cardiac, renal and liver disease
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1,Handayama,Higashi-ku,Hamamatsu-shi,Shizuoka,431-3192 Japan
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dai Hashimoto
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1,Handayama,Higashi-ku,Hamamatsu-shi,Shizuoka,431-3192 Japan
TEL 053-435-2263
Homepage URL
Email dai@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
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 浜松医科大学医学部附属病院(静岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 27 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 Open public recruiting
Date of protocol fixation
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 27 Day
Last modified on
2013 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012095

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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