UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008394 |
|---|---|
| Receipt number | R000009868 |
| Scientific Title | Effects of adding budesonide/formoterol in patients with COPD |
| Date of disclosure of the study information | 2012/07/10 |
| Last modified on | 2013/02/09 15:28:42 |
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Basic information
Public title
Effects of adding budesonide/formoterol in patients with COPD
Acronym
Effects of budesonide/formoterol
Scientific Title
Effects of adding budesonide/formoterol in patients with COPD
Scientific Title:Acronym
Effects of budesonide/formoterol
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate changes of pulmonary function adding budesonide/formoterol in COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary function test
Key secondary outcomes
Imaging
St. George's Respiratory Questionnaire (SGRQ)
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
Inhaled budesonide/formoterol 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic obstructive pulmonary disease (COPD)
Patients can use the inhaled therapy
Patients gave written informed consent
Key exclusion criteria
History of hyper-sensitivity to budesonide/formoterol
Patients with bronchial asthma
Patients during acute exacerbation
Presence of infectious disease, pneumothorax, and severe heart failure
Target sample size
15
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, Hamamatsu, Shizuoka, 431-3192, Japan
TEL
053-435-2263
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Yasui |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal medicine
Zip code
Address
TEL
053-435-2263
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S1094553913000515
Number of participants that the trial has enrolled
Results
MDCT demonstrated budesonide/formoterol induced bronchodilation in the non-small airway. CT imaging can evaluate drug therapeutic effect and may provide additional insights into pharmacotherapy for COPD.
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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 09 | Day |
Last modified on
| 2013 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009868
