UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003401 |
|---|---|
| Receipt number | R000004123 |
| Scientific Title | The effect of add-on beta2 agonist in paitents with COPD treatd with tiotropium |
| Date of disclosure of the study information | 2010/03/29 |
| Last modified on | 2010/03/29 17:27:48 |
* 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
The effect of add-on beta2 agonist in paitents with COPD treatd with tiotropium
Acronym
The effect of add-on beta2 agonist in paitents with COPD treatd with tiotropium
Scientific Title
The effect of add-on beta2 agonist in paitents with COPD treatd with tiotropium
Scientific Title:Acronym
The effect of add-on beta2 agonist in paitents with COPD treatd with tiotropium
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tioropium is one of the most effecitve drug on the treatment of COPD paitnets. When the diesease become severer, paitnets are often treated with several kinds of inhaled bronchodilators. However, few data are available about the 2nd choice of the bronchodiltors in paitents with COPD who are already treated with tiotropium. Thus the aim of this study is to investigate the effect of add-on short acting beta2 agonist in patients with COPD treated with tiotropium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Dyspnae scale, QoL
Key secondary outcomes
the frequency of on demand use of bronchodilators, the frequency of exacerbation, lung functions
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
inhaled short acting beta2 agonist
Interventions/Control_2
inhaled long acting beta2 agonist
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
COPD patients who are diagnosed by the criteria of GOLD guideline, and treated with tiotropium.
1) FEV1/FVC <0.7
30%<=%FEV1<80%
2) suffer from dyspnea
3) over 40years old
4) have a smoking history
5) does not change other treatment
Key exclusion criteria
1) bronchial asthma
2) needs systemic steroids
3) under long term oxygen therapy
4) drug aleergy
5) who are not suitable for beta2 inhalation (hyperthyroidism, hypertension,and so on)
6) glaucoma
7) miction imparement
8) pregnacy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Muro |
Organization
Kyoto univeristy, faculty of medicine
Division name
respiratory medicine
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3830
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Muro |
Organization
Kyoto univeristy, faculty of medicine
Division name
respiratory medicine
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3830
Homepage URL
smuro@kuhp.kyoto-.ac.jp
Sponsor or person
Institute
Kyoto university hhospital, resipiratory medicine
Institute
Department
Personal name
Funding Source
Organization
Health promoting association for Respiratory Medicine of Nishi-Nippon
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Keisei-kai
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
| 2010 | Year | 03 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 29 | Day |
Last modified on
| 2010 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004123
