UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003401
Receipt No. 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

* 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
Email

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
Email smuro@kuhp.kyoto-.ac.jp

Sponsor
Institute Kyoto university hhospital, resipiratory medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004123

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.