UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter randomized controlled crossover trial comparing the efficacy of LABA or LAMA in patient with COPD
Acronym	Investigation of treatment response in patient with COPD
Scientific Title	A multicenter randomized controlled crossover trial comparing the efficacy of LABA or LAMA in patient with COPD
Scientific Title:Acronym	Investigation of treatment response in patient with COPD
Region	Japan

Condition
Condition	Chronic Obstructive Pulmonary Disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the background factors of the patients who showed different treatment responses in being administered tiotropium and indacaterol. The patients were in the second or third stage of COPD. The medicine was administered in order, not simultaneously.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the background factors of the patients who showed significant differences through a pulmonary function test four weeks after the intervention.
Key secondary outcomes	To investigate the background factors of the patients who showed significant differences through CAT, TDI and IPAQ four weeks after the intervention.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We evaluate the result after the patients inhaled tiotropium for four weeks. Then, we switch from tiotropium to indicaterol, observe the progress for four weeks, and evaluate the result.
Interventions/Control_2	We evaluate the result after the patients inhaled indicaterol for four weeks. Then, we switch from indicaterol to tiotropium, observe the progress for four weeks, and evaluate the result.
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	1)A Patient who is visiting our outpatient clinic, is over 40 years of age, and has smoking history 2)A patient who is classified into the second or third stage of COPD in pulmonary function test. 3)A patient who smoke 1 pack per day for 10 years or more 4)A patient who agreed to participate in the study with the written informed consent
Key exclusion criteria	1)A patient who cannot be performed a respiratory function test appropriately 2)A Patients with asthma. 3)A patients who have has experienced an acute COPD exacerbation or respiratory tract infection within the past 4 weeks prior to the informed consent 4)A patients with advanced malignant tumor 5)A patients who are is pregnant 6)A patients who are is allergic to tiotropium or ipratropium 7)A patients receiving oxygen inhalation for more than 15 hours/day 8) A patient whom the doctor in charge judged unsuitable as subjected is excluded.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Hironori Middle name Last name Sagara
Organization	Showa University School of Medicine
Division name	Division of Allergology and Respiratory Medicine
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
TEL	03-3784-8704
Email	sagarah@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Kuniaki Middle name Last name Hirai
Organization	Showa University School of Medicine
Division name	Division of Allergology and Respiratory Medicine
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
TEL	03-3784-8000
Homepage URL
Email	medi123@infoseek.jp

Sponsor
Institute	Showa University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
Tel	03-3784-8000
Email	ctsc.admin@ofc.showa-u.ac.jp

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	2016 Year 04 Month 24 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Publication of results	Unpublished

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Number of participants that the trial has enrolled	40
Results	The examination was finished without a clear harmful phenomenon. The final analysis had not been finished, but LAMA accepted the patient who was easy to be effective. The objective effect did not accord with the impression of the patient for the drug. The analysis was over and was announced at the Respiratory Society of 2018.
Results date posted	2019 Year 11 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The clinical characteristics of participating patients were not significantly different from those of previous studies.
Participant flow	After two types of bronchodilators were crossed over and inhaled, an objective evaluation and a subjective evaluation were performed.
Adverse events	There were no adverse events in the patient.
Outcome measures	We did not find any characteristic results in objective evaluation items such as respiratory function, CAT, and mMRC and subjective evaluation items.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 01 Day
Date of IRB	2015 Year 11 Month 27 Day
Anticipated trial start date	2016 Year 04 Month 25 Day
Last follow-up date	2017 Year 10 Month 26 Day
Date of closure to data entry	2017 Year 10 Month 26 Day
Date trial data considered complete	2017 Year 10 Month 26 Day
Date analysis concluded	2018 Year 10 Month 26 Day

Other
Other related information	We excluded Yamanashi red cross hospital. We are going to concluding our study when about 60 patients are included. It is because, more than patients will not participate in our study. So, we are going to analyze about 60 people now.

Management information
Registered date	2016 Year 04 Month 24 Day
Last modified on	2021 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023905