Tolerance and Effect of an add-on Treatment With a Cough Medicine Containing Ivy Leaves Dry Extract on Lung Function in Children With Bronchial Asthma
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MEF75-25 before bronchodilation - relative change
研究概览
简要总结
The trial aims to record possible effects of a supplementary treatment with ivy leaves dry extract on different lung function parameter, on bronchial hyperreactivity, on individual markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is, that the additional therapy might improve these parameters and might help to optimize asthma therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in terms of the bronchial asthma NVL Version 1.3 (2011)
- •Children aged from 6 to 12 years (girls and boys)
- •Signed Informed Consent of the patient and his legal guardians to participate in the trial after written and verbal briefing by the Investigator
- •Improvement of the FEV1≥12% after 2 puffs of terbutaline 100 µg dur-ing steroid monotherapy with 400 µg budesonide equivalent/day or an ACT score ≤ 19 as an indication of insufficient asthma control
- •Asthma diagnosis for at least 1 year
排除标准
- •Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
- •Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
- •Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
- •Inability to measure lung function, to test bronchospasmolysis, to determine FeNO or to collect exhaled breath condensate, inability to document the symptoms in a symptom log book or questionnaire; in-ability to take the trial medication properly
- •Chronic illnesses of different aetiology
- •Vocal cord dysfunction
- •Premature birth or diagnosis of bronchopulmonary dysplasia
- •Gastroesophageal reflux
- •Acute respiratory infection within the previous 4 weeks
- •Hereditary fructose intolerance
- •Pregnant or breastfeeding girls -
研究组 & 干预措施
Ivy leave
active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks
干预措施: ivy leaves dry extract (Drug)
Placebo
Ivy leave placebo 5 ml twice daily p.o. for four weeks
干预措施: Placebo (Drug)
结局指标
主要结局
MEF75-25 before bronchodilation - relative change
时间窗: every 4 weeks
MEF75-25 will be measured at every time point of the study and relative changes will be followed
FEV1 before bronchodilation - relative change
时间窗: every 4 weeks
FEV1 before bronchodilation will be measured at every study visit and changes will be documented
次要结局
- MEF75-25 before bronchodilation - absolute change(every 4 weeks)
- FEV1 before bronchodilation - absolute change(every 4 weeks)
- Emergency treatment (beta agonist demand)(daily)
- Number of days with asthma symptoms(daily)