UMIN-CTR Clinical Trial

Basic information
Public title	Effects of glycopirronium inhalation therapy evaluated by change of physical activity for untreated chronic obstructive pulmonary disease (COPD) patients.
Acronym	OPH-R-COPD-1402
Scientific Title	Effects of glycopirronium inhalation therapy evaluated by change of physical activity for untreated chronic obstructive pulmonary disease (COPD) patients.
Scientific Title:Acronym	OPH-R-COPD-1402
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to investigate improvement of daily physical activity accessed by uniaxial accelerometers (Kenz Lifecorder Ex) for outpatients with moderate to severe chronic obstructive pulmonary disease (COPD) treated with a long-acting muscarinic antagonist, glycopirronium, inhalation therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Proportion of activity intensity of 1 or more, accessed by accelerometer.
Key secondary outcomes	1. Pulmonary functions; FVC, FEV1,FEV1%, V50, V25 2. QOL and activity ; CAT, SF-36, modified MRC 3. Physical activity; calorie consumption, steps, amount of exercise 4. Arterial blood test; PaO2, PaCO2 5. Exacerbation episode

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	glycopirronium inhalation therapy
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. Age 40 years-old or older 2. A history of cigarette smoking or excessive exposure to smoke. 3. Clinically stable moderate-to-severe COPD, according to the Global Initiative on Obstructive Lung Disease (GOLD) staging. 4. Never treated with long-acting beta-agonists (LABA) or more than 4 weeks after last LABA inhalation. 5. Never treated with long-acting muscarinic antagonists (LAMA) or more than 4 weeks after last LAMA inhalation. 6. Able to walk independently or with a cane. 7. Sufficient cognitive function to follow the instructions for using the pulse oximetry equipment and accelerometers. 8. Written informed consent.
Key exclusion criteria	1. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 2. Closed angle glaucoma 3. Severe urination disorder 4. A history of hypersensitivity reaction against glycopirronium 5. A recent history of respiratory infection and acute exacerbation in the previous one month. 6. Clinically severe athma. 7. Other significant cardiac diseases or medical problems precluding ambulatory activity at hom 8. Physician's decision.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name Minami
Organization	Osaka Police Hospital
Division name	Department of Respiratory Medicine
Zip code	543-0035
Address	10-31 Kitayama-cho Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL	81-6-6771-6051
Email	seigominami@oph.gr.jp

Public contact
Name of contact person	1st name Seigo Middle name Last name Minami
Organization	Osaka Police Hospital
Division name	Department of Respiratory Medicine
Zip code	543-0035
Address	10-31 Kitayama-cho Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL	81-6-6771-6051
Homepage URL
Email	seigominami@oph.gr.jp

Sponsor
Institute	Department of Respiratory Medicine, Osaka Police Hospital
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, Osaka Police Hospital
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	Ethical Review Comittee
Address	10-31 Kitayama-cho Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
Tel	06-6771-6051
Email	shomu@oph.gr.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	大阪警察病院（大阪）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 26 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
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	Enrolling by invitation
Date of protocol fixation	2014 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 18 Day
Last modified on	2019 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016654