UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023312 |
|---|---|
| Receipt number | R000026861 |
| Scientific Title | Effects of budesonide/formoterol in COPD patients with eosinophilic airway inflammation |
| Date of disclosure of the study information | 2016/07/26 |
| Last modified on | 2017/07/25 16:46:09 |
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Basic information
Public title
Effects of budesonide/formoterol in COPD patients with eosinophilic airway inflammation
Acronym
Effects of budesonide/formoterol in COPD patients with eosinophilic airway inflammation
Scientific Title
Effects of budesonide/formoterol in COPD patients with eosinophilic airway inflammation
Scientific Title:Acronym
Effects of budesonide/formoterol in COPD patients with eosinophilic airway inflammation
Region
| Japan |
Condition
Condition
CPOD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of inhaled budesonide/formoterol combination in COPD patients with eosinophilic airway inflammation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in FEV1 between week 0 and week 8.
Key secondary outcomes
Change in FVC between week 0 and week 8
Change in FEV1/FVC between week 0 and week 8
Change in FOT parameters between week 0 and week 8
Change in CAT between week 0 and week 8
Change in mMRC between week 0 and week 8
Change in FeNO between week 0 and week 8
Change in sputum eosinophils between week 0 and week 8
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
Additive administration of budesonide/formoterol
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A Patient who is visiting our outpatient clinic, is over 40 years of age, and has smoking history
2) A patient who smoke 1 pack per day for 10 years or more
3) A patient who agreed to participate in the study with the written informed consent
4) A patients who have FeNO >35 ppb or sputum eosinophils >3%
Key exclusion criteria
1) A Patients with asthma.
2) A patients who have has experienced an acute COPD exacerbation or respiratory tract infection within the past 12 weeks prior to the informed consent
3) A patients receiving oxygen inhalation
4) A patient whom the doctor in charge judged unsuitable as subjected is excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taisuke Akamatsu |
Organization
Shizuoka General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
4-27-1 Kita-Ando, Aoi, Shizuoka, 420-8527, Japan
TEL
054-247-6111
taisuke-akamatsu@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taisuke Akamatsu |
Organization
Shizuoka General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
4-27-1 Kita-Ando, Aoi, Shizuoka, 420-8527, Japan
TEL
054-247-6111
Homepage URL
taisuke-akamatsu@i.shizuoka-pho.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Shizuoka General Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 26 | 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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 26 | 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
| 2016 | Year | 07 | Month | 24 | Day |
Last modified on
| 2017 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026861
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
