UMIN-CTR Clinical Trial

Basic information
Public title	Association of changes in dyspnea, lung function, and physical activity by Indacaterol/Glycopyrronium combination in patients with COPD
Acronym	Changes in lung function and physical activity by LAMA/LABA therapy in COPD
Scientific Title	Association of changes in dyspnea, lung function, and physical activity by Indacaterol/Glycopyrronium combination in patients with COPD
Scientific Title:Acronym	Changes in lung function and physical activity by LAMA/LABA therapy in COPD
Region	Japan

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

Objectives
Narrative objectives1	This trial is aimed to assess the association of changes in dyspnea, lung function, and physical activity by bronchodilation therapy in patients with COPD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary objective of this trial is to investigate the change in PA over a 12-week in response to QVA-149 (long-acting beta2 agonists (LABA)/long-acting muscarinic receptor antagonists (LAMA)) therapy in patients with COPD.
Key secondary outcomes

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	QVA-149 (long-acting beta2 agonists (LABA)/long-acting muscarinic receptor antagonists (LAMA)
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	1) Written informed consent must be obtained before any assessment is performed 2) Aged >=40 years with mild-to-moderate stable COPD 3) A post-bronchodilator FEV1 of >=50% of the predicted normal, have a post-bronchodilator FEV1 to FVC ratio of <0.70 4) Either current smokers or ex-smokers with a smoking history of >=10 pack-years 5) A modified Medical Research Council (mMRC) dyspnea scale grade of at least 1
Key exclusion criteria	1) Moderate-to-severe COPD exacerbation (requiring antibiotics, systemic steroids or hospitalization) within the 4 weeks before the screening 2) Requiring LABA and LAMA combination therapy 3) Requiring long-term oxygen therapy 4) Requiring short-acting beta2-agonista (SABA) relief use of more than 8 puffs/day 5) Concomitant pulmonary disease including asthma (FeNO<50ppb at baseline) 6) Any physical disorder that would prevent the patient from being able to complete the assessments 7) Long QT syndrome at screening, or a clinically significant electrocardiogram abnormality 8) History of closed angle glaucoma, and/or ischuria due to prostatic disease 9) There is a history of hypersensitivity to components of the Urutiburo
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Kazuto Middle name Last name Matsunaga
Organization	Graduate School of Medicine, Yamaguchi University
Division name	Department of Respiratory Medicine and Infectious Disease
Zip code	755-8505
Address	1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL	0836-85-3123
Email	kokyuki@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Kazuto Middle name Last name Matsunaga
Organization	Graduate School of Medicine, Yamaguchi University
Division name	Department of Respiratory Medicine and Infectious Disease
Zip code	755-8505
Address	1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL	0836-85-3123
Homepage URL
Email	kokyuki@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University
Institute
Department

Funding Source
Organization	Novartis pharma
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB, Yamaguchi University
Address	Minami-kogushi 1-1-1, Ube
Tel	+81836853123
Email	kazmatsu@yamaguchi-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 10 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	45
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	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 27 Day
Date of IRB	2016 Year 06 Month 27 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2021 Year 10 Month 05 Day
Date of closure to data entry	2021 Year 10 Month 05 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 02 Day
Last modified on	2021 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027928