UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009174 |
|---|---|
| Receipt number | R000010763 |
| Scientific Title | Effect of budesonide/formoterol in chronic obstructive pulmonary disease patients with low peak inspiratory flow rate |
| Date of disclosure of the study information | 2012/10/23 |
| Last modified on | 2015/04/19 03:59:41 |
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Basic information
Public title
Effect of budesonide/formoterol in chronic obstructive pulmonary disease patients with low peak inspiratory flow rate
Acronym
Effect of budesonide/formoterol in chronic obstructive pulmonary disease patients with low peak inspiratory flow rate
Scientific Title
Effect of budesonide/formoterol in chronic obstructive pulmonary disease patients with low peak inspiratory flow rate
Scientific Title:Acronym
Effect of budesonide/formoterol in chronic obstructive pulmonary disease patients with low peak inspiratory flow rate
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of budesonide/formoterol in COPD patients with low peak inspiratory flow rate
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of various indicators
1) Respiratory Function (FEV1,% FEV1)
2) CAT (COPD Assessment Test) score
Key secondary outcomes
Airway resistance (R5, R20, R5-R20)
Change of HADS (Hospital Anxiety and Depression Scale)
Safety
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
budesonide/formoterol 160/4.5 mcg, two inhalations twice a day
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
1) Aged>=20years old
2) Diagnosed COPD
3) %FEV <=80%, CAT score >=20, or appropriate case considered by physician
4) Low peak inspiratory flow rate (30~60L/min.)
5) Provided written consent prior to enrollment
Key exclusion criteria
1) Infections with no available effective antimicrobial drugs or with deep mycosis
2) A history of hypersensitivity (including contact dermatitis)to any ingredient contained in budesonide/formoterol
3) Tuberculosis
4) Case with the following complications
a) Severe liver disease
b) Severe renal disease
5) Planning-to-be-pregnant, pregnant or lactating patients
6) Inappropriate case considered by physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsunori Hino |
Organization
Chiba-Hokusoh Hospital, Nippon Medical School
Division name
Department of Respiratory Medicine
Zip code
Address
1715 Kamagari, Inzai, Chiba 270-1694, Japan
TEL
0476-99-1961
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsunori Hino |
Organization
Chiba-Hokusoh Hospital, Nippon Medical School
Division name
Department of Respiratory Medicine
Zip code
Address
1715 Kamagari, Inzai, Chiba 270-1694, Japan
TEL
0476-99-1961
Homepage URL
hino@nms.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
日本医科大学千葉北総病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 23 | 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
| 2012 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 23 | 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
| 2012 | Year | 10 | Month | 23 | Day |
Last modified on
| 2015 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010763
| 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 |
