UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005459 |
|---|---|
| Receipt number | R000006473 |
| Scientific Title | Add-on therapy for COPD receiving inhaled bronchodilators |
| Date of disclosure of the study information | 2011/04/19 |
| Last modified on | 2012/04/18 21:22:17 |
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Basic information
Public title
Add-on therapy for COPD receiving inhaled bronchodilators
Acronym
Add-on therapy for COPD receiving inhaled bronchodilators
Scientific Title
Add-on therapy for COPD receiving inhaled bronchodilators
Scientific Title:Acronym
Add-on therapy for COPD receiving inhaled bronchodilators
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether combining bronchodilators (ex.salmeterol-fluticasone and tiotropium) improves FEV1 and QOL compared with monotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of FEV1
Improvement of CAT total score
Key secondary outcomes
COPD symptom (cough, phlegm, breathlessness)
Stratified analysis of baseline CAT score
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 on tiotropium (18microg, twice daily) to current medications
or
Add on salmeterol (50microg, twice daily) to current medications
or
Add on salmeterol /fluticasone (50/250 microg, twice daily) to current medications
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
A subject will be eligible for inclusion in this study if all of the following criteria are met:
1)Gender: Both
2)Age: >=40
3)outpatients
4)Both emphysema and non-emphysema
5) GOLD stage >= II (%FEV1<80%)
6)receiving long-acting bronchodilaotr (LAMA, LABA, ICS/LABA combination) as continuous use for
greater than 3 months
7)have respiratory symptoms (cough, phlegm, breathlessness )
8)able to comply with the requirements of the protocol
Key exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria
apply:
1) have lung infection and unable to be eligible for inclusion based on investigator's judgment.
2)have experience of exacerbation within 3 months.
3) receiving combination therapy of tiotropium and ICS/LABA
4) there is a current diagnosis of asthma, in the opinion of the investigator
5)serious allergy to medicine
6)In the opinion of the investigator, there is safety concern if add-on medication to current therapy.
7) The investigator judge to exclude
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Katayama |
Organization
Ehime University Graduate School ofMedicine
Division name
Department of Integrated Medicine and Informatics
Zip code
Address
Toon, Ehime, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ehime University Graduate School ofMedicine
Division name
Department of Integrated Medicine and Informatics
Zip code
Address
TEL
089-960-5303
Homepage URL
Sponsor or person
Institute
EACC (Ehime Asthma COPD Conference)
Institute
Department
Personal name
Funding Source
Organization
EACC (Ehime Asthma COPD Conference)
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
愛媛大学医学部附属病院（愛媛県）
愛媛県立中央病院（愛媛県）
独立行政法人国立病院機構愛媛病院（愛媛県）
愛媛赤十字病院（愛媛県）
住友別子病院（愛媛県）
愛媛生協病院（愛媛県）
放射線第一病院（愛媛県）
北条病院（愛媛県）
喜多医師会病院（愛媛県）
四国中央病院（愛媛県）
ひらやま内科・呼吸器科クリニック（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 19 | 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
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 04 | Month | 18 | Day |
Last modified on
| 2012 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006473
