UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003192 |
|---|---|
| Receipt number | R000003840 |
| Scientific Title | Additive effects of short-acting bronchodilators in COPD patients who still had dyspnea in their daily lives despite long-acting bronchodilators. |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2017/08/31 15:26:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Additive effects of short-acting bronchodilators in COPD patients who still had dyspnea in their daily lives despite long-acting bronchodilators.
Acronym
Additive effects of short-acting bronchodilators on dyspnea in COPD.
Scientific Title
Additive effects of short-acting bronchodilators in COPD patients who still had dyspnea in their daily lives despite long-acting bronchodilators.
Scientific Title:Acronym
Additive effects of short-acting bronchodilators on dyspnea in COPD.
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose in this study is to examine additive effects of short-acting bronchodilators, beta-2-agonist or anti-cholinergic agent, on dyspnea on exertion and exercise tolerance in moderate to severe COPD patients who still had dyspnea in their daily lives despite therapy of long-acting bronchodilators including tiotropium at least.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exercise tolerance and maximum Borg Scale for dyspnea on shuttle walking test.
Key secondary outcomes
Spirometry and dynamic hyperinflation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single inhalation of procaterol hydrochloride 20 microgram.
Interventions/Control_2
Single inhalation of oxytropium bromide 0.2 mg.
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
| 45 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with moderate to severe chronic obstructive pulmonary disease (COPD) in stable phase, who recruited from outpatient clinic of Shinshu University Hospital and still have dyspnea on exertion despite therapy with long-acting bronchodilators including tiotropium at least.
Key exclusion criteria
The patients who considered to have risks for exercise test, such as coronary vascular disease, arythmia, and heart failure are excluded from this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisaku Fujimoto |
Organization
Shinshu University School of Medicine
Division name
Department of Biomedical Laboratory Sciences, Health Sciences
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2393
keisaku@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisaku Fujimoto |
Organization
Shinshu University School of Mdedicine
Division name
Department of Biomedical Laboratory Sciences, Health Sciences
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2393
Homepage URL
keisaku@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Biomedical Laboratory Sciences, Shinshu University School of Health Sciences.
Institute
Department
Personal name
Funding Source
Organization
Subscription money
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
信州大学医学部付属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2009 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003840
