UMIN-CTR Clinical Trial

Basic information
Public title	Clinical effect of acupuncture on patients with chronic obstructive pulmonary disease
Acronym	Clinical trial of acupuncture in COPD patients
Scientific Title	Clinical effect of acupuncture on patients with chronic obstructive pulmonary disease
Scientific Title:Acronym	Clinical trial of acupuncture in COPD patients
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effects of acupuncture for three months on exercise tolerance and QOL of patients with COPD (Stage II - IV).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Peak oxygen uptake Endurance time SGRQ score
Key secondary outcomes	Borg scale O2-pulse VD/VT VE/Vo2 VE/Vco2 Respiratory muscle strength Plasma concentration of norepinephrine Body weight CAT score mMRC dyspnea scale Pulmonary function test (Mostgraph, Expiratory FeNo) 24-h heart rate variability Daily physical activities measured using Activision marker Skeletal muscle mass, bone mass, and fat measured using Dual-Energy X-ray Absorptiometry (DEXA)

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	Other
Interventions/Control_1	Acupuncture Once weekly for 12 weeks
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)COPD determined according to diagnostic criteria and classified as stage II or more using the GOLD criteria. Those rated as grade >= 1 according to modified Medical Research Council dyspnea scale (mMRC). 2)Aged > 40 years 3)Stable patients able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation. 4)Signed agreement to participate in the study
Key exclusion criteria	1)Malignant tumors 2)Active infectious disease 3)Severe heart disease 4)Hepatic failure 5)Renal failure 6)Drug regimen changed during clinical trials 7)Participation in pulmonary rehabilitation programs 8)Judged inadequate to participate in the study by their physicians
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keisuke Miki
Organization	National Hospital Organization Toneyama National Hospital
Division name	Laboratory Chief, Laboratory of Respiratory Science, Division of Clinical Research
Zip code
Address	5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL	06-6853-2001
Email	mikisuke@toneyama.go.jp

Public contact
Name of contact person	1st name Middle name Last name Keisuke Miki
Organization	National Hospital Organization Toneyama National Hospital
Division name	Laboratory Chief, Laboratory of Respiratory Science, Division of Clinical Research
Zip code
Address	5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL	06-6853-2001
Homepage URL
Email	mikisuke@toneyama.go.jp

Sponsor
Institute	National Hospital Organization Toneyama National Hospital
Institute
Department

Funding Source
Organization	Grant-in-Aid for Clinical Research from National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	独立行政法人　国立病院機構 刀根山病院

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 25 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	Completed
Date of protocol fixation	2015 Year 05 Month 15 Day
Date of IRB	2015 Year 05 Month 15 Day
Anticipated trial start date	2015 Year 05 Month 25 Day
Last follow-up date	2021 Year 05 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 18 Day
Last modified on	2021 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020397