Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia

A 12-Week, Randomised, Placebo Controlled, Multi-Centre, Parallel Group Study Assessing the Safety and Tolerability of Nutrifriend Cachexia (Non-Complete Dietary Formula) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

SF-K002 is a pilot study in patients with moderate to severe COPD suffering from involuntary weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of Nutrifriend Cachexia.

This study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. The primary objective is to evaluate the safety and tolerability of Nutrifriend Cachexia in patients with COPD. The secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, lung function, compliance, appetite and Quality of Life.

Inclusion Criteria:

• Age >50 years
• Moderate to severe COPD patients with forced expiratory volume (FEV1) of 30-60%
• Involuntary weight loss <10%
• 18 kg/m2 ≤ BMI ≤ 32 kg/m2

Exclusion Criteria:

• Exacerbation of COPD within 3 months prior to screening
• Treatment with oral corticosteroids (>5 mg/day) within 3 months prior to screening
• Treatment with anabolic steroids within 3 months prior to screening
• Current oxygen treatment or home ventilation therapy
• Change in smoking habits during the previous 6 months
• Major changes in COPD maintenance treatment within 3 months prior to screening
• Other cachectic disorders such as cancer, renal or hepatic disorders