Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Uncomplicated Acute Bronchitis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 668
- 试验地点
- 12
- 主要终点
- Duration of moderate-severe cough in days in the four arms.
研究概览
简要总结
This study, which is aimed at comparing the effectiveness of 3 symptomatic therapies (dextromethorphan, ipratropium and honey) associated with usual care and the usual care in adults with acute bronchitis, is a multicentre, pragmatic, parallel group, open randomised trial. Patients aged 18 or over with uncomplicated acute bronchitis, with cough <3 weeks as the main symptom, scoring ≥ 4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the 4 groups. Sample: 668 patients. The primary outcome will be the number of days with moderate-severe cough.
详细描述
Despite the frequent use of therapies in acute bronchitis, encouraged by the over-the-counter availability in pharmacies, the evidence of their benefit is scarce, since only a few clinical trials have been published, with low sample sizes, poor methodological quality and mainly in children. The objective of this study is to compare the effectiveness of 3 symptomatic therapies (dextromethorphan, ipratropium and honey) associated with usual care and the usual care in adults with acute bronchitis. This will be a multicentre, pragmatic, parallel group, open randomised trial. Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than three weeks as the main symptom, scoring ≥ 4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the following four groups: usual care, usual care + dextromethorphan 30 mg t.i.d., usual care + ipratropium bromide inhaler 20 µg 2 puffs t.i.d, or usual care + 30 mg (a spoonful) of honey t.i.d., all taken for up to 14 days. The exclusion criteria will be: pneumonia, criteria for hospital admission, pregnancy or lactation, concomitant pulmonary disease, associated significant comorbidity, allergy, intolerance or contraindication to any of the study drugs, admitted to a long-term residence, or inability to give informed consent. Sample: 668 patients. The primary outcome will be the number of days with moderate-severe cough in the intention-to-treat (ITT) population, i.e., the number of days from the randomisation visit until the last day the patient scores three or more in either daytime or nocturnal cough in the symptom diary. All patients will be given a symptom diary to be self-administered while symptoms are present. A second visit will be scheduled at day 2-3 for assessing evolution, with two more visits at days 15 and 29 for clinical assessment, evaluation of adverse effects, re-attendance and complications. Patients still with symptoms at day 29 will be called six weeks after the baseline visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or older, and
- •symptoms of acute bronchitis with cough starting within 3 weeks before study inclusion, and
- •patients who score ≥ 4 in either the daytime and/or nocturnal cough on a 7-point Likert scale, and
- •patients who consent to participate.
排除标准
- •suspected pneumonia; if the professional suspects pneumonia, a chest X-ray will be recommended and the patient will be randomized if this diagnosis is discarded; or
- •criteria for hospital admission (impaired consciousness, respiratory rate > 30 breaths/minute, pulse > 125 beats/minute, systolic blood pressure <90 mm Hg or diastolic blood pressure <60 mm Hg, temperature > 104°F or oxygen saturation <92%)
- •pregnancy or breast feeding
- •baseline respiratory disease such as chronic obstructive pulmonary disease, asthma, tuberculosis or bronchiectasis
- •associated significant comorbidity, such as moderate-severe heart failure, dementia, acute myocardial infarction/recent cerebral vascular accident (< 3 months), severe liver failure, severe renal failure
- •immunosuppression, such as chronic infection by HIV, transplanted, neutropenic, or patients receiving immunosuppressive treatment
- •active neoplasm
- •terminal illness
- •history of intolerance or allergy to any of the study treatments
- •patients in whom, in the opinion of the investigator, treatment with dextromethorphan, ipratropium bromide or honey is contraindicated
- •patients living in long-term institutions
- •difficulty in conducting scheduled follow-up visits
研究组 & 干预措施
Dextromethorphan
Usual clinical practice + dextromethorphan (15 milligrams unit), one 15 mg-tablet t.i.d. up to a maximum of 14 days.
干预措施: Dextromethorphan 15 milligrams (Drug)
Ipratropium
Usual clinical practice + ipratropium bromide 20Micrograms Inhaler each puff), 2 puffs t.i.d. up to a maximum of 14 days.
干预措施: Ipratropium Bromide 20Micrograms Inhaler (Drug)
Honey
Usual clinical practice + Honey 30 g (full tablespoon) t.i.d. up to a maximum of 14 days. Patients will be given two 750 milligram bottles of wildflower honey (the most frequent type of honey used in our country) and patients will be recommended to add the honey to a cup of lemon or thyme juice, milk herbal tea, yogurt, as a hot toddy, etc.
干预措施: Honey 30 g (full tablespoon) (Dietary Supplement)
Usual clinical practice
Usual care.
干预措施: Usual clinical practice (Other)
结局指标
主要结局
Duration of moderate-severe cough in days in the four arms.
时间窗: Day 29.
Number of days until the last day the patient scores 3 in either daytime cough or nocturnal cough in the symptom diary. Each symptom will be scored by the patient on a 7-point Likert scale, which has been used in previous studies (0=not affected; 1=very little problem; 2=slight problem; 3=moderately bad; 4=bad; 5=very bad; 6=as bad as it could be).
次要结局
- Duration of cough in days in the four arms.(Days 15 and 29. If the patient continues to score 2 or more at day 29 will be called at day 43.)
- Duration of moderate-severe daytime cough in days in the four arms.(Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.)
- Duration of moderate-severe nocturnal cough in days in the four arms.(Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.)
- Duration of symptoms in days in the four arms.(Days 15 and 29. If the patient continues to score 2 or more at day 29 will be called at day 43.)
- Duration of moderate-severe cough in days according to the basal degree of bronchial hyper-reactiveness in the four arms.(The peak-flow will be determined at day 1.)
- Percentage of antibiotics and different symptomatic treatments used in the four arms.(Days 2-4, 15 and 29.)
- Number of days of absence from work in the four arms.(Day 15.)
- Patients re-attendance for symptoms related to the episode of acute bronchitis within the first 42 days.(Day 29 and phone call at day 43.)
- Number of complications related to the episode of acute bronchitis within the first 28-42 days.(Day 29-43.)
- Duration of moderate-severe symptoms in days in the four arms.(Days 15 and 29. If the patient continues to score 3 or more at day 29 will be called at day 43.)
- Duration of severe symptoms in days in the four arms.(Days 15 and 29.)
- Number of adverse events in the four arms.(Days 2-4, 15 and 29.)
- Patient satisfaction in the four arms.(Day 15 or 29.)