UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of ghrelin administration in patients with chronic obstructive pulmonary disease
Acronym	Ghrelin therapy for chronic obstructive pulmonary disease
Scientific Title	Clinical trial of ghrelin administration in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym	Ghrelin therapy for chronic obstructive pulmonary disease
Region	Japan

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

Objectives
Narrative objectives1	The purpose of the present study is to investigate the effects of ghrelin administration in cachexic patients with chronic obstructive pulmonary disease in a multicenter, randomized, double-blind, placebo-controlled clinical trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	QOL score (SGRQ) Six-minute walk distance
Key secondary outcomes	QOL score (SF-36) Medical Research Council (MRC) dyspnea scale Food intake Vital capacity (VC) FEV1% Maximal inspiratory pressure Maximal expiratory pressure Plasma norepinephrine level Peak oxygen uptake

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Synthetic human ghrelin (2ug/kg, dissolved in 10 ml of sterile saline) is administered to cachexic patients with COPD participating in pulmonary rehabilitation (cycle ergometer training). Ghrelin is administered intravenously for 30 minutes. The infusion is repeated twice a day (before breakfast and before dinner) for three weeks.
Interventions/Control_2	Sterile saline (10mL) is administered to cachexic patients with COPD participating in pulmonary rehabilitation (cycle ergometer training). Saline is administered intravenously for 30 minutes. The infusion is repeated twice a day (before breakfast and before dinner) for three weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with moderate to severe COPD (FEV1% < 70%, %FEV1 < 50%) Patients with weight loss (BMI < 21kg/m^2) Patients whose conditions are stable and who can participate in pulmonary rehabilitation Patients who are between 20 and 85 in age Patients who have signed the agreement for participation in this study
Key exclusion criteria	Patients with malignant tumors Patients with active infection Patients with severe heart disease Patients with hepatic failure (serum levels of AST and ALT greater than twice the normal upper limit) Patients with renal failure (serum creatinine concentration >= 2.0 mg/dL) Patients with asthma Patients who are or could be pregnant Patients whose drug regimen was changed within one month before participation in this study In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenji Kangawa
Organization	National Cardiovascular Center Research Institute
Division name	Deputy Director of Research Institute
Zip code
Address	5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan
TEL	06-6833-5012
Email

Public contact
Name of contact person	1st name Middle name Last name Noritoshi Nagaya
Organization	National Cardiovascular Center Research Institute
Division name	Department of Regenerative Medicine & Tissue Engineering
Zip code
Address	5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan
TEL	06-6833-5012
Homepage URL
Email	nnagaya@ri.ncvc.go.jp

Sponsor
Institute	National Cardiovascular Center Research Institute
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Toneyama National Hospital Nara Medical University Faculty of Medicine, University of Miyazaki Osaka City University Medical School
Name of secondary funder(s)	National Institute of Biomedical Innovation the Promotion of Fundamental Studies in Health Science

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

Other administrative information
Date of disclosure of the study information	2005 Year 08 Month 15 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
Date of protocol fixation	2005 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2005 Year 09 Month 01 Day
Last follow-up date	2006 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 08 Month 15 Day
Last modified on	2010 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000103

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