A safety and efficacy clinical study of the investigational medicinal product BYM338 for the treatment of unintentional weight loss in patients with chronic obstructive pulmonary disease
- Conditions
- Cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) GOLD stage II to IVMedDRA version: 16.0 Level: PT Classification code 10006895 Term: Cachexia System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-000461-12-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 67
• Written informed consent must be obtained before any assessment is performed.
• Males and females ages 40 to 80 years
• Smoking history of at least 10 pack-years
• Diagnosis of COPD according to GOLD guidelines (GOLD, 2010), with a post-bronchodilator FEV¬1 < 80% predicted and FEV1/FVC ratio < 0.70
• BMI <20 kg/m2 or skeletal muscle mass index by DXA < 7.25 kg/m2 for men or <5.45 kg/m2 for women.
• In general stable health, including managed COPD, by past medical history, physical examination, vital signs at baseline as determined by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• Patients with MRC dyspnoea grade 5 (i.e. patients too breathless to leave the house or breathless when dressing)
• Patients weighing = 120 kg
• Plans for lung transplantation or lung reduction surgery within four months of enrollment
• Patients participating in a formal pulmonary rehabilitation program within 3 months of dosing
• History of malignancy of any organ system (other than excised non-melanomatous carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Diseases other than cancer known to cause cachexia or muscle atrophy, including but not limited to congestive heart failure of any stage, chronic kidney disease (estimated GFR < 30 mL/min using the MDRD equation), rheumatoid arthritis, primary myopathy, stroke, HIV infection, tuberculosis or other chronic infection, uncontrolled diabetes mellitus, etc.
• Any other clinically relevant disease or disorder e.g., infectious/viral disease (including hepatitis B or C), cardiovascular (including unstable ischaemic heart disease, arrythmia, cardiomyopathy, uncontrolled hypertension), pulmonary disease other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, past or present, which in the opinion of the Investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study.
• Patients who are status post splenectomy or organ transplant, on anti-TNFa medication, or are immunocompromised (e.g. IgA or other immunoglobulin).
• Diseases known to cause malabsorption of protein or energy, such as inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency, etc.
• Usual dietary intake < 20 kcal/kg and 0.6 g protein/kg estimated by food frequency questionnaire over the 4 weeks prior to screening.
• Use of any prescription drugs known to affect muscle mass, including androgen supplements, anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.) recombinant human growth hormone (rhGH), insulin, oral beta agonists, megestrol acetate, dronabinol, metformin, etc.
• Hospitalization within 14-days prior to screening
• Hemoglobin concentration below 11.0 g/dL at screening.
• Liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), ?-GT, alkaline phosphatase, or serum bilirubin (other than Gilbert's Disease). The Investigator should be guided by the following criteria: Any single transaminase listed above may not exceed 3x upper limit of normal (ULN); If the total bilirubin concentration is increased above 1.5 x ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. Total serum bilirubin should not exceed 2 x ULN.
• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
• History of hypersen
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method