UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of switching to Tiotropium / Olodaterol combination in patients with COPD
Acronym	The effectiveness of switching to Tiotropium / Olodaterol combination
Scientific Title	The effectiveness of switching to Tiotropium / Olodaterol combination in patients with COPD
Scientific Title:Acronym	The effectiveness of switching to Tiotropium / Olodaterol combination
Region	Japan

Condition
Condition	COPD
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness of switching from Glycopirronium / Indacaterol or Umeclidinium / Vilanterol to Tiotropium / Olodaterol combination in COPD patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in FEV1 between week 0 and week 8
Key secondary outcomes	Change in FVC between week 0 and week 8 Change in FOT parameters between week 0 and week 8 Change in CAT between week 0 and week 8 Change in mMRC between week 0 and week 8

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switching from Glycopirronium / Indacaterol or Umeclidinium / Vilanterol to Tiotropium / Olodaterol combination
Interventions/Control_2
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	-Diagnosis of moderate-to-severe COPD. -Post-bronchodilator FEV1/FVC < 70%. -Post bronchodilator FEV1 < 80% predicted normal. -Smoking history of 10 pack-years or more. -Patients treated with Glycopirronium / Indacaterol or Umeclidinium / Vilanterol to Tiotropium / Olodaterol.
Key exclusion criteria	-Patients with a history of asthma. -Patients who are already treated with ICS or oral corticosteroid regularly. -Patients who have experienced a COPD exacerbation within the previous 8 weeks. -Patients with uncontrolled cardiac diseases.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Taisuke Middle name Last name Akamatsu
Organization	Shizuoka General Hospital
Division name	Department of Respiratory Medicine
Zip code	4208527
Address	4-27-1 Kita-Ando, Aoi, Shizuoka, 420-8527, Japan
TEL	054-247-6111
Email	taisuke-akamatsu@i.shizuoka-pho.jp

Public contact
Name of contact person	1st name Taisuke Middle name Last name Akamatsu
Organization	Shizuoka General Hospital
Division name	Department of Respiratory Medicine
Zip code	4208527
Address	4-27-1 Kita-Ando, Aoi, Shizuoka, 420-8527, Japan
TEL	054-247-6111
Homepage URL
Email	taisuke-akamatsu@i.shizuoka-pho.jp

Sponsor
Institute	Shizuoka General Hospital
Institute
Department

Funding Source
Organization	self funding
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	Clinical Research Ethics Board
Address	4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan
Tel	054-247-6111
Email	chiken-sougou@shizuoka-pho.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 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.scirp.org/journal/paperinformation.aspx?paperid=98170
Number of participants that the trial has enrolled	57
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	Completed
Date of protocol fixation	2016 Year 10 Month 01 Day
Date of IRB	2016 Year 09 Month 21 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2021 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 29 Day
Last modified on	2022 Year 06 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028828