Chronic obstructive pulmonary disease
Conditions
Interventions
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 a
Sponsors
National Cardiovascular Center Research Institute
Toneyama National Hospital Nara Medical University Faculty of Medicine, University of Miyazaki Osaka City University Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QOL score (SGRQ) Six-minute walk distance | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNoritoshi Nagaya
National Cardiovascular Center Research Institute Department of Regenerative Medicine & Tissue Engineering
Outcome results
None listed