Clinical trial of ghrelin administration in patients with chronic obstructive pulmonary disease

UMIN ID: C000000061

Registered date:15/08/2005

Basic Information

• Health condition(s) or Problem(s) studied: Chronic obstructive pulmonary disease
• Date of first enrollment: 2005/09/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

• Primary Outcome: QOL score (SGRQ) Six-minute walk distance
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: National Cardiovascular Center Research Institute
• Secondary Sponsor: Toneyama National Hospital Nara Medical University Faculty of Medicine, University of Miyazaki Osaka City University Medical School
• Source(s) of Monetary Support: Ministry of Health, Labour, and Welfare,National Institute of Biomedical Innovation the Promotion of Fundamental Studies in Health Science