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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003192
Receipt No. 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

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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
Email 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
Email keisaku@shinshu-u.ac.jp

Sponsor
Institute Department of Biomedical Laboratory Sciences, Shinshu University School of Health Sciences.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003840

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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