BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
Condition: Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Wasting Syndrome; Cachexia
Intervention: Placebo; BYM338
Intervention description: BYM338
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic Obstructive Pulmonary Disease; COPD; cachexia; muscle wasting

Summary:

      This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of
      BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh
      muscle volume compared to placebo. The study will last for approximately 24 weeks.
    

Eligibility criteria:

        Inclusion criteria:

          -  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.

        Exclusion criteria:

          -  Patients with MRC dyspnoea grade 5 (i.e. patients too breathless to leave the house or
             breathless when dressing)

          -  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.

          -  Inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic
             insufficiency

          -  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.

          -  Hemoglobin concentration below 11.0 g/dL at screening.

          -  Liver disease or liver injury.

          -  Use of other investigational drugs at the time of enrollment, or within 30 days and
             for any other limitation of participation in an investigational trial based on local
             regulations.

          -  Women of child-bearing potential.

        Other protocol-defined inclusion/exclusion criteria may apply