UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005185 |
|---|---|
| Receipt number | R000006156 |
| Scientific Title | Treatment with formoterol/budesonide in patients with asthma |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2013/03/04 09:19:35 |
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Basic information
Public title
Treatment with formoterol/budesonide in patients with asthma
Acronym
Treatment of formoterol/budesonide for asthma
Scientific Title
Treatment with formoterol/budesonide in patients with asthma
Scientific Title:Acronym
Treatment of formoterol/budesonide for asthma
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effectiveness of formoterol/budesonide
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
FEV1 at week 0 and week 12
Key secondary outcomes
V50 at week 0 and week 12
V25 at week 0 and week 12
FVC at week 0 and week 12
Exhaled NO at week 0 and week 12
Adverse events at week 0 and week 12
Mean rate of all exacerbations at week 0 and week 12
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch from salmeterol/fluticasone one inhalation twice daily to formoterol/budesonide two inhalation twice daily
Interventions/Control_2
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Salmeterol/budesonide 50/250ug one inhalation twice daily at constant dose for >2 months
Ability and willingness to provide informed consent
Key exclusion criteria
History of hypersensitivity to budesonide
History or presence of lung, cardiac, renal and liver desease
Use of systemic corticosteroids
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kingo Chida |
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taisuke Akamatsu |
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
Homepage URL
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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(静岡県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 03 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | 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
| 2011 | Year | 03 | Month | 03 | Day |
Last modified on
| 2013 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006156
