A Randomized Controlled, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy and Safety of CARDIO® in Adult Asthmatics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change of severe and moderate events
研究概览
简要总结
Research has over decades showed that marine food carries nutritional characteristics that promote human health. As seen in epidemiological studies and based on in vitro and in vivo studies, it is hypothesized that unrefined salmon oil as dietary supplement have anti-inflammatory effect. However, there is sufficient preliminary data to indicate bioactive compounds effect for clinical use, and further clinical trials investigating effect are needed. This trial will investigate the potential anti-inflammatory effect in adults diagnosed with asthma.
详细描述
This study is a double-blind, placebo-controlled, randomized trial investigating unrefined salmon oil, CARDIO®, additional to standard care for asthmatics. The investigational product is an unrefined salmon oil based soft-gel formulation containing 21 different fatty acids (more than 99.1%), lipopeptides (less than 0.9%), antioxidants and other micro metabolites. Research has shown that marine foods carry nutritional characteristics that promote human health, particularly the high intake of long-chain n-3 polyunsaturated fatty acid (n-3 PUFA), eicosapentaeonic acid (EPA), and docosahexaenoic acid (DHA). Cell culture and mice studies have reported a reduction in leucocytes infiltration of the lungs and decreased pro-inflammatory cytokines with the consumption of the n-3 PUFAs, EPA and DHA. However, clinical trials in humans diagnosed with asthma, have shown varied results investigating n-3 PUFA supplementation. The purpose of this study is to investigate whether CARDIO® has an anti-inflammatory effect preventing exacerbation, in enhanced asthma control and quality of life. Data will be collected by pulmonary function tests (PEF, spirometry and FeNO), blood sample, nutritional log, quality of life questionnaires (ACQ-5), and blood and stool collected for research biobanking. Study intervention period will be 20 weeks, plus 4 weeks post-intervention follow-up, foremost of safety reasons.
As this study is explorative in nature, a sample size which balance the need of statistical power and resource constraints is chosen. The available resources, predetermine those 80 participants, 40 in each arm, can be recruited. We include a margin of error due to drop-out rate of about 20% in total (8 subjects per group), we thus estimate the study requires a recalculated number of 100 participants (50 in each arm). With this number of participants, the study is able to detect a decrease in rate of exacerbations of 40% (i.e. a rate ratio of 0.6), under the assumptions of a significance level of 5%, a power of 80% and an individual event rate of 0.01 pr day in the control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma Global Initiative for Asthma (GINA) treatment grade 2-4 (only standard care of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), no additional treatment except as-needed short--acting beta2-agonist (SABA)
- •ACQ-5 score ≥0.75
- •Diagnosed with asthma by medical doctor (general practitioner or pulmonary spesialist)
- •Eosinophils ≥ 150 µL
- •Speaks fluent Norwegian.
- •For female in fertile age, use of contraception or other indication for non-pregnancy.
- •Signed informed consent and expected cooperation of the participants for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
排除标准
- •Treatment with oral corticosteroid <1 month prior to baseline visit
- •Treatment with any biological medication, <6 months prior to baseline visit
- •Oral/intravenous antibiotics < 3 months prior to baseline visit
- •Consumption of fish oil (liquid, capsule, powder) as an oral supplement < 1-month prior baseline visit
- •Known fish or shellfish allergy
- •Pregnancy and breast feeding
- •Participant in a confounding study
- •Inflammatory bowel disease (Chron, ulcerative colitis (UC), microscopic colitis), celiac disease, or any chronic disease that possibly affects intestinal absorption and morbidity
- •In case of severe cognitive impairment where the participants are not able to fulfill the study
- •Not willing to participate
- •Any reason why, in the opinion of the investigator, the participant cannot participate.
结局指标
主要结局
Change of severe and moderate events
时间窗: Change from day 0 (baseline) to 20 weeks.
The comparison of the rate of exacerbations between treatment groups: Best standard care (BSC) + CARDIO®, and BSC + placebo. Exacerbations will be defined as severe event (requiring oral corticosteroids, or hospitalization) or moderate events defined using a composite index. Composite index are calculated using composite variable set as PEF, reliever use of SABA, day time symptoms and night-time awakenings. Measurement one og twice a day from day 0 (baseline) to 20 weeks, depending on different variables. Measurement achieved at participants resident with delivered PEF -equipment and digital platform (application (APP)) designed for self-reporting measurement.
次要结局
- Time to first composite event(Day 0 (baseline) to 20 weeks.)
- Rate of reduction in pulmonary measurement PEF(Day 0 (baseline) to week 20.)
- Change of white blood cells(Day 0 (baseline) to week 20.)
- Change in Immunoglobulin E (IgE)(Day 0 (baseline) to week 20.)
- Number of days without use of SABA per participant(Day 0 (baseline) to 20 weeks.)
- Change in pro-inflammatory cytokines(Day 0 (baseline) to week 20.)
- Self-reported questionnaire ACQ-5(Day 0 (baseline) to week 24.)
- Incidence of Treatment-Emergent Adverse Events(Day 0 (baseline) to week 24.)
- Rate of severe exacerbation(Day 0 (baseline) to 20 weeks.)
- Concentration of SCFA in stool(Day 0 (baseline) to week 20.)