Exploratory Study of Lipoic Acid Supplementation on Oxidative Stress, Inflammatory and Functional Markers in Asthmatic Patients: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Spirometric FEV1 Values at Baseline
研究概览
简要总结
The aim of the study is to use the antioxidant and antiinflammatory effects of lipoic acid to improve the quality of life of patients with asthma.
The investigators will administrate 600 mg lipoic acid orally on a daily basis during two months concurrent with the patient anti-asthmatic therapy and evaluate the effects on resulting pulmonary function, inflammatory and oxidative stress biomarkers and health-related quality of life previous to the initial of the treatment and at 60 days of the supplementary therapy.
详细描述
Asthma is an inflammatory disease of high prevalence around the world. During development of asthma the presence of oxidative stress has been related to susceptibility and severity of the disease, thus making the use of antioxidant adjuvant therapy with lipoic acid (LA) an interesting treatment option. The objective of the study is to evaluate the efficacy of LA as an adjuvant treatment on functional, antioxidant, inflammatory, quality and control parameters of asthma in human subjects. The trial design is a randomized, double blind, placebo controlled parallel study.
Adult patients (>18 years) with history of mild intermittent to moderate asthma according to the Global Initiative for Asthma (GINA) guidelines were enrolled. It was required a positive skin prick test (>3 mm) for at least two regional allergens. Patients were randomly assigned to receive lipoic acid or placebo for 60 days. Participants had an intermediate visit to the attending physician one month after initial of treatment to monitor adverse events and to undergo laboratory tests.
- Introduction. Asthma is an inflammatory disease of high prevalence around the world. During development of asthma the presence of oxidative stress has been related to susceptibility and severity of the disease, thus making the use of antioxidant adjuvant therapy with lipoic acid (LA) an interesting treatment option.
- Study design. A randomized, double blind, placebo controlled parallel study
- Methods. Participants and interventions: 55 patients with mild to moderate asthma from Hospital Civil "Juan I. Menchaca" in Guadalajara, Jalisco, México were included and randomized in block of 10 to receive; LA (600 mg/day) or placebo for eight weeks from January to October of 2011.
- Objective. To evaluate the efficacy of LA as an adjuvant treatment on functional, antioxidant, inflammatory, quality and control parameters of asthma in human subjects. Primary outcome: change on Forced expiratory volume in 1 second (FEV1), secondary outcomes were levels of Oxygen radical absorbance capacity (ORAC), glutathione (GSH), glutathione disulfide (GSSG), protein carbonyls, differential count of sputum cells, interleukin-4 (IL-4) and scores of quality of life and control of asthma questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- •Outpatients (≥18 and ≤ 75 years of age) female or male
- •Willingness to participate and comply with procedures by signing a written informed consent
- •Moderate/severe persistent allergic rhinitis according to Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines with a history of intermittent, mild persistent or moderate persistent asthma according to GINA guidelines
- •Confirmed allergy to at least one of the following allergen preparations: house dust mite f; house dust mite p; cockroach; bush mix; tree mix; grass mix; weed mix, cat; or dog.
- •All prior medication washout times had been observed
- •Female volunteers of childbearing potential had to agree to use a medically accepted method of contraception
- •Negative urine pregnancy test
- •Without a concomitant chronic medical condition (e.g., significant cardiovascular disease, diabetes requiring medication, chronic kidney disease, chronic thyroid disease, or coagulation defects)
- •Willingness to adhere to the dosing and visit schedules
排除标准
- •Pregnant or breastfeeding
- •Female who was or intended to become pregnant during the study or within 12 weeks after study completion
- •Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications
- •Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps)
- •Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants
- •Upper respiratory tract or sinus infection that required antibiotic therapy and had not had at least a 14-day wash-out period prior to the run-in period
- •Patients undergoing a progressive course of immunotherapy. Subjects on a regular maintenance schedule prior to the screening visit are eligible for study inclusion; however, subject could not receive hyposensitization treatment within 24 hours prior to any study visit
- •Concomitant medical problem
- •In a situation or condition that could interfere with participation in the study
- •Allergic or sensitivity to the study drug or its excipients
- •History of inadequate adherence to treatment
研究组 & 干预措施
Placebo
Placebo (two placebo capsules) orally once daily in the morning during 60 days
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Spirometric FEV1 Values at Baseline
时间窗: Baseline
Measurement of spirometric predicted parameters at baseline: Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.
Spirometric FVC Values at Baseline
时间窗: Baseline
Measurement of spirometric predicted parameters at baseline. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
Spirometric FVC Values at Endpoint
时间窗: 60 days
Measurement of spirometric predicted parameters at the baseline and after 60 days of treatment: Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
Spirometric FEF Values at Endpoint
时间窗: 60 days
Measurement of spirometric FEF after 60 days of treatment: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.
Spirometric FEV1 Values at Endpoint
时间窗: 60 days
Measurement of spirometric predicted parameters after 60 days of treatment. Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.
Spirometric FEF Values at Baseline
时间窗: Baseline
Measurement of spirometric parameters at baseline: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.
次要结局
- Induced Sputum Carbonylated Proteins at Baseline(Baseline)
- Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline(Baseline)
- Induced Sputum Eosinophils at Baseline(Baseline)
- Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint(60 days)
- Induced Sputum Eosinophils at Endpoint(60 days)
- Induced Sputum Carbonylated Proteins at Endpoint(60 days)
- Inflammatory IL-4 Sputum Levels at Endpoint(60 days)
- Measurement of Quality of Life With the ACT (Asthma Control Test) at Endpoint(60 days)
- Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Endpoint(60 days)
- Inflammatory Interleukin-4 (IL-4) Sputum Levels at Baseline(Baseline)
- Measurement of Quality of Life With the ACT (Asthma Control Test) at Baseline(Baseline)
- Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Baseline(Baseline)
研究者
Fernando Siller-Lopez
Research professor
Centro Universitario de Ciencias de la Salud, Mexico