UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003735 |
|---|---|
| Receipt number | R000004383 |
| Scientific Title | Efficacy and safety of budesonide /formeterol inhalation in asthma patients with high fractional exhaled NO. |
| Date of disclosure of the study information | 2010/06/14 |
| Last modified on | 2013/08/23 15:44:50 |
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Basic information
Public title
Efficacy and safety of budesonide /formeterol inhalation in asthma patients with high fractional exhaled NO.
Acronym
Efficacy and safety of budesonide /formeterol inhalation in asthma patients with high fractional exhaled NO.
Scientific Title
Efficacy and safety of budesonide /formeterol inhalation in asthma patients with high fractional exhaled NO.
Scientific Title:Acronym
Efficacy and safety of budesonide /formeterol inhalation in asthma patients with high fractional exhaled NO.
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of budesonide /formeterol on peripheral airway inflammation and airway function in stable asthma using lung function, alveolar nitric oxide and impulse oscillometry.
And to examine the safety of budesonide/formoterol by symptoms and laboratory data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary function levels at 0, 4, 12 weeks.
Fractional exhaled nitric oxide levels at 0, 4, 12 weeks.
Values of impulse oscillometry at 0, 4, 12 weeks
Adverse events
Key secondary outcomes
Exacerbations during 12weeks
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
Add inhaled budesonide/ formoterol twice daily
to the current medication for 12 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In patients with bronchial asthma, all of the following criteria are required for enrollment:
1) age;20 years or more
2) written informed consent from the patients
3) FeNO>=20ppb
4) can visit hospital for 3months
Key exclusion criteria
1) have hypersensitivity with budesonide
2) have any severe complications
3) use of oral corticosteroids or systemic rescue medication
4) physician decided the patient is unsuitable for enrollment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Iwata |
Organization
Komaki City Hospital
Division name
department of respiratory medicine
Zip code
Address
Jobusi 1-20, Komaki, Aichi, Japan
TEL
0568764131
sin@komakihp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Iwata |
Organization
Komaki City Hospital
Division name
department of respiratory medicine
Zip code
Address
Jobusi 1-20, Komaki, Aichi, Japan
TEL
0568764131
Homepage URL
sin@komakihp.gr.jp
Sponsor or person
Institute
Komaki City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | 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 | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | 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
| 2010 | Year | 06 | Month | 10 | Day |
Last modified on
| 2013 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004383
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
