UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of switching from tiotropium/indacaterol to glycopyrronium/indacaterol combination in patients with COPD.
Title of the study (Brief title)	The effectiveness of switching from tiotropium/indacaterol to glycopyrronium/indacaterol combination in patients with COPD.
Region	Japan

Condition
Condition	Chronic obstructive pulmonary disease (COPD)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness of switching from tiotropium/indacaterol to glycopirronium/indacaterol 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 FEV1/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	Parallel
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	Switching from tiotropium/indacaterol to glycopirronium/indacaterol combination.
Interventions/Control_2	Continuation of tiotropium/indacaterol.
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 tiotropium and indacaterol for more than 2 weeks.
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	60

Research contact person
Name of lead principal investigator	Taisuke Akamatsu
Organization	Shizuoka General Hospital
Division name	Department of Respiratory Medicine
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	Taisuke Akamatsu
Organization	Shizuoka General Hospital
Division name	Department of Respiratory Medicine
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	Department of Respiratory Medicine, Shizuoka General Hospital
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)

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	2015 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 27 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 28 Day
Last modified on	2018 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020076