A Double Blind Randomised Placebo Controlled Trial of Montelukast in the Treatment of Acute Persistent Cough in Young People and Adults in Primary Care
试验速览
- 阶段
- 4 期
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation.
研究概览
简要总结
Persistent cough is a common symptom, accounting for about 20% of referrals to outpatient chest clinics. Most coughs are caused by self-limiting viral infections such as the common cold. However, 1 in 4 people with a viral infection develop a persistent cough, which can go on for several weeks. Whooping cough is a common cause of persistent cough in young people and adults. Although the whooping cough vaccine gives lifelong protection against severe infection, it does not appear to give such long-term protection against milder infections, which can make someone cough for many weeks. There are currently no proven efficacious treatments for persistent cough following either a viral infection or infection with whooping cough.
Montelukast is a medication which is already licensed for the treatment of asthma. It works by blocking the action of chemicals called leukotrienes, which make the airways of people with asthma inflamed and sensitive. There is strong evidence to suggest that leukotrienes are also involved in causing persistent cough following viral or whooping cough infection. Montelukast may therefore also help settle persistent coughs in these settings.
Over 18 months, we will recruit patients aged 16-49 years with a cough lasting 2-8 weeks from general practices in England. An oral fluid sample will be taken from each participant to be tested for whooping cough. Participants will be randomly allocated to receive a 28-day course of montelukast or placebo tablets and asked to complete a daily cough diary for two weeks. They will be assessed after two weeks by their GP (face-to-face) and after four weeks by another member of practice clinical staff (telephone). Some participants will be given a 24-hour cough monitor to wear on study entry and at two-week follow-up. This study will be funded by the National Institute for Health Research's School of Primary Care.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, aged 16 years to 49 years inclusive.
- •Presenting with a persistent cough of 2-8 weeks' duration without an established diagnosis (e.g. asthma, gastro-oesophageal reflux).
- •Able to complete cough diary and study questionnaires.
排除标准
- •There is a contraindication to montelukast.
- •Chronic severe disease which may cause persistent cough (eg cystic fibrosis, bronchiectasis, cardiac failure).
- •Immunodeficiency/immunocompromised state.
- •Pregnancy.
- •Breastfeeding.
- •Current smoker (i.e. stopped smoking less than 6 months ago).
- •Regular medication associated with persistent cough (ACE inhibitors).
- •The individual is in another clinical research study.
研究组 & 干预措施
Montelukast
干预措施: Montelukast (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation.
时间窗: 2 and 4 weeks post randomisation
次要结局
- Change in Leicester Cough Questionnaire (LCQ) physical, psychological and social domain scores at 2 and 4 weeks post randomisation.(2 and 4 weeks post randomisation)
- Overall cough severity according to cough visual analogue scale (VAS) scores over the 2-week period post randomisation (area under the curve).(2 weeks post randomisation)
- Paroxysmal cough severity over the 2-week period post randomisation (area under the curve).(2 weeks post randomisation)
- Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation.(2 and 4 weeks post randomisation)
- Recruitment rate among young people and adults presenting with acute persistent cough.(End of study)
- Follow-up rates at 2 weeks and 4 weeks post randomisation.(2 weeks and 4 weeks post randomisation.)
- Medication adherence rates at 2 and 4 weeks post randomisation.(2 and 4 weeks post randomisation)
- Prevalence of whooping cough among participants.(End of study)
- Correlations between subjective cough outcome measures (diary-recorded paroxysms of cough, cough visual analogue scale score and exercise-related cough score) and objective cough frequency measured using the Leicester Cough Monitor.(2 and 4 weeks post randomisation)
- Proportions of participants undergoing further intervention (re-consultation, investigation, prescription of other medication).(4 - 8 weeks)
- Proportions of participants with adverse events.(End of study)