Clinical trial NCT02442908: Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Cachexia
Lead sponsor: Smartfish AS
Sponsor class: INDUSTRY
First posted: 2015-05-13
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition assessed by fat mass and lean body mass (LBM)
timeFrame: 12 weeks
measure: Body composition assessed by weight, BMI and waist & calf circumference
timeFrame: 12 weeks
measure: Function assessed by 6 minute walking test
timeFrame: 12 weeks
measure: Function assessed by grip strength
timeFrame: 12 weeks
measure: Function assessed by walking distance
timeFrame: 12 weeks
measure: Inflammation
timeFrame: 12 weeks
measure: Metabolic markers
timeFrame: 12 weeks
measure: QoL assessed by COPD Assessment Test (CAT)
timeFrame: 12 weeks
measure: QoL assessed by COPD Clinical Questionnaire (CCQ)
timeFrame: 12 weeks
measure: QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C)
timeFrame: 12 weeks
measure: QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
timeFrame: 12 weeks
measure: QoL assessed by Nutrition Appetite Questionnaire (CNAQ)
timeFrame: 12 weeks
measure: Compliance assessed by Drinks consumed
timeFrame: 12 weeks
measure: Compliance assessed by vitamin D levels
timeFrame: 12 weeks
measure: Compliance assessed by Omega-3 incorporation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Ladulaas kliniska studier
city: Helsingborg
country: Sweden
facility: Pharmasite
city: Malmö
country: Sweden
facility: Pharmasite
city: Stockholm
country: Sweden
facility: A+ Science City Site
Study officials:
References:
citation: Calder PC, Laviano A, Lonnqvist F, Muscaritoli M, Ohlander M, Schols A. Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial. J Cachexia Sarcopenia Muscle. 2018 Feb;9(1):28-40. doi: 10.1002/jcsm.12228. Epub 2017 Sep 10.