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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Smartfish AS
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD
时间窗: 12 weeks
次要结局
- Function assessed by walking distance(12 weeks)
- QoL assessed by COPD Assessment Test (CAT)(12 weeks)
- Body composition assessed by fat mass and lean body mass (LBM)(12 weeks)
- Body composition assessed by weight, BMI and waist & calf circumference(12 weeks)
- Function assessed by 6 minute walking test(12 weeks)
- Function assessed by grip strength(12 weeks)
- Inflammation(12 weeks)
- QoL assessed by COPD Clinical Questionnaire (CCQ)(12 weeks)
- QoL assessed by Nutrition Appetite Questionnaire (CNAQ)(12 weeks)
- Compliance assessed by vitamin D levels(12 weeks)
- Metabolic markers(12 weeks)
- Compliance assessed by Drinks consumed(12 weeks)
- Compliance assessed by Omega-3 incorporation(12 weeks)
- QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire(12 weeks)
- QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C)(12 weeks)