UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Additive effects of short-acting bronchodilators in COPD patients who still had dyspnea in their daily lives despite long-acting bronchodilators.
Title of the study (Brief title)	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	Keisaku Fujimoto
Organization	Shinshu University School of Medicine
Division name	Department of Biomedical Laboratory Sciences, Health Sciences
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2393
Email	keisaku@shinshu-u.ac.jp

Public contact
Name of contact person	Keisaku Fujimoto
Organization	Shinshu University School of Mdedicine
Division name	Department of Biomedical Laboratory Sciences, Health Sciences
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 10 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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