Evaluation of Halotherapy as Asthma Treatment in Children: a Randomized, Controlled, Double-blind Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Provocative concentration causing a 20% fall in the forced expiratory volume at one second (PC20-FEV1) as assessed by Methacholine Challenge Test
研究概览
简要总结
Background: Asthma is a chronic inflammatory disorder requiring intermittent or continuous anti-inflammatory therapy. Patients often turn to alternative treatments as complements or replacements to conventional treatments.
Aim: To evaluate the effect of salt room chambers (halotherapy) on bronchial hyper- responsiveness (BHR), fractional exhaled nitric oxide (FeNO), and quality of life in children with asthma.
Patients: Children aged 5-13 years with a clinical diagnosis of mild asthma not receiving anti-inflammatory therapy.
Methods: Randomized, double-blind, placebo-controlled study assessing the effect of salt room therapy on BHR, FeNO, spirometry and pediatric asthma quality of life questionnaire (PAQLQ). The treatment period lasted 7 weeks, 14 sessions with (treatment group) or without salt halogenerator.
详细描述
Asthma is a chronic inflammatory disorder requiring intermittent or continuous anti-inflammatory therapy. Patients often turn to alternative treatments as complements or replacements to conventional treatments.
Our aim: To evaluate the effect of salt room chambers (halotherapy) on bronchial hyper - responsiveness (BHR), fractional exhaled nitric oxide (FeNO), and quality of life in children with asthma.
Patients: Children aged 5-13 years with a clinical diagnosis of mild asthma not receiving anti-inflammatory therapy.
Methods: Randomized, double-blind, placebo-controlled study assessing the effect of salt room therapy on BHR, FeNO, spirometry and pediatric asthma quality of life questionnaire (PAQLQ). The treatment period lasted 7 weeks, 14 sessions with (treatment group) or without salt halogenerator.
Visit 1: Written parental consent. Demographics, child's asthma/atopy history, and family history of asthma/atopy/smoking. The Pediatric asthma quality of life questionnaire (PAQLQ) by the patient/caregiver and the interviewer. Each patient performed spirometry, methacholine challenge test (MCT) and FeNO measurements. Following a positive MCT, patients were randomized to 14 sessions (7 weeks, twice weekly, 45 minutes each treatment) sitting in a salt room with salt aerosol produced by a halogenerator (study group) or halotherapy without salt aerosol (placebo). Both the walls and the ceiling of the salt room are completely covered with European Salt Company (ESCO) type certified-origin rock salt. The temperature (20-24°C) and humidity (44-60%) are at constant values. The halogenerator is located outside the salt room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5-13 years
- •Mild asthma
- •Positive methacholine challenge test (MCV, PC20-FEV1 <16mg/ml)
排除标准
- •Any Chronic Lung Disease
- •Febrile Illness in last 2 weeks
- •FEV1 < 65% in study day
- •Bronchodilators over the past 24 hours prior to each study
- •Participation in any other clinical studies over the past 4 weeks
- •Any acute illness on the day of the MCT,
- •Anti-inflammatory treatment (inhaled corticosteroids or montelukast) over the previous two weeks before the MCT).
- •Systemic corticosteroids in the two months prior to enrollment
- •Emergency room (ER) visit or hospital admission following a respiratory illness during the 2-month period prior to enrollment.
- •Previous halotherapy treatment.
结局指标
主要结局
Provocative concentration causing a 20% fall in the forced expiratory volume at one second (PC20-FEV1) as assessed by Methacholine Challenge Test
时间窗: Study visit 1,2 (7 wks)
次要结局
- Determination of exhaled Nitric Oxide in exhaled breath(Study visit study 1,2 (7 wks))
- Pulmonary function as assessed by spirometry(Study visit study 1,2 (7 wks))
- Quality of life of childhood asthma as assessed by the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ)(Study visit study 1,2 (7 wks))