UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effectiveness of ALA for an improvement of exercise tolerability in patients with COPD: pilot study
Title of the study (Brief title)	Effectiveness of ALA for an improvement of exercise tolerability in patients with COPD.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate of the effectiveness of ALA for an improvement of exercise tolerability in patients with COPD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	6-minute walk distance (after 4weeks of ALA or placebo p.o)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	5-aminolevulinic acid(ALA)(100mg/day for 4weeks)
Interventions/Control_2	placebo (4weeks p.o)
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 patients(GOLD II or III) 2 Patients who complain dyspnea on exertion 3 Patients who undergo pulmonary function tests 4 Patients who understand this pilot study 5 Patients who obtained a written informed consent
Key exclusion criteria	1 Patient's will of withdrawal from this study 2 Serious adverse events 3 Worsening of the symptomes due to COPD 4 Chnage of the medications for COPD 5 Doctor's judgement of the discontinuance of the study
Target sample size	12

Research contact person
Name of lead principal investigator	Kazuhisa Takahashi
Organization	Juntendo University, Faculty of Medicine
Division name	Division of Respirology
Address	2-1-1 Hongo, Bunkyo-Ku, Tokyo
TEL	03-3813-3111
Email	kztakaha@juntendo.ac.jp

Public contact
Name of contact person	Mitsuaki Sekiya
Organization	Juntendo University, Faculty of Medicine
Division name	Division of Respirology
Address	2-1-1 Hongo, Bunkyo-Ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	msekiya@juntendo.ac.jp

Sponsor
Institute	Juntendo University, Faculty of Medicine
Institute
Department

Funding Source
Organization	Juntendo University, Faculty of Medicine
Organization
Division
Category of Funding Organization	Other
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	順天堂大学医学部附属順天堂医院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 30 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 06 Month 24 Day
Anticipated trial start date	2016 Year 09 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	2016 Year 07 Month 15 Day
Last modified on	2017 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026718