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

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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 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


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

Value
https://center6.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