Exploring the Effect of Azithromycin on Oesophageal Motility and Respiratory Symptoms in Patients With Chronic Respiratory Disease: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Symptoms such as cough, wheeze, and breathlessness are among the most common reasons for general practitioner or emergency department visits in the UK. Such symptoms have a profound impact on patients' ability to live a fulfilled life, often rendering people unable to work and socialise.
Azithromycin (a type of antibiotic) improves symptoms and reduces flare-ups of diseases such as asthma and chronic obstructive pulmonary disease (COPD). The reason why it works is unclear. Many people believe that it either decreases the number of bacteria in the lungs or reduces inflammation in the lungs and the upper airways. Neither theory is proven. Another possible mechanism that has been much less studied is that Azithromycin encourages the body to move food and fluid through the gut more quickly, thus preventing reflux and aspiration of small food particles and stomach acid. It has been shown that lung damage can occur when gut contents enter the airways, which may contribute chronic lung disease patients' symptoms
In this study the investigators will test the effect of azithromycin on the gut in patients with chronic lung diseases. The investigators will measure the strength of a patients swallow by measuring the pressures in their gullet, using high-resolution oesophageal manometry (HROM), before and after treatment, in people being started on azithromycin as part of their routine care. The investigators will also measure the effect that azithromycin has on their symptoms and observe whether there is a relationship between the strength of their swallow and their symptoms.
At the end of this study, the investigators hope to better understand the way in which azithromycin helps to improve the symptoms of patients with chronic lung diseases. The investigators also hope to open the door to investigate the effect of other drugs that improve gut function in patients with chronic lung diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males and females aged ≥18 years.
- •Have a diagnosis of chronic respiratory disease (COPD, asthma, interstitial lung disease, chronic cough, cystic fibrosis, and/or bronchiectasis) confirmed by a respiratory consultant.
- •Exhibit symptoms consistent with airway reflux, demonstrated by a score ≥14 on the Hull Airways Reflux Questionnaire
- •Are being initiated on azithromycin as part of routine clinical care, as judged by their usual respiratory clinician. This will include all common treatment regimes, 250mg once daily, 250mg three times per week, and 500mg three time per week.
- •Are willing and able to consent to all study procedures.
排除标准
- •Previous treatment with long-term macrolides in the past 3 months.
- •Unable to be investigated with HROM due to contraindications such as anatomical abnormalities or diseases of the oesophagus or unwilling/ unable to be investigated with HROM based on the clinical judgement of the investigators due to severity of lung disease.
- •Have another cardiorespiratory cause for their symptoms (such as heart failure or lung cancer).
- •Women of child bearing potential not using effective means of contraception.
- •Are unable or unwilling to consent to or complete the study procedures.
结局指标
主要结局
Recruitment rate
时间窗: 1 year
The number of participants successfully recruited per month
Participant retention to follow-up
时间窗: 1 year
The proportion of those participants who consent to take part that compete all study measures to follow-up
Eligibility to consent ratio
时间窗: 1 year
The ratio of participants deemed eligible to participate in the study to the number of those who provide consent to take part
Acceptability of assessment
时间窗: 1 year
Quantify the proportion of participants who judge the study investigations, principally HROM, to be acceptable.
次要结局
- Numerical rating scale - breathlessness severity(1 month)
- Breathlessness, cough, and sputum scale(1 month)
- Asthma control questionnaire (asthma patients only)(1 month)
- Leicester Cough Questionnaire(1 month)
- King's Brief Interstitial Lung Disease Questionnaire (ILD Patients only)(1 month)
- Distal Contractile Integrity(1 month)
- Distal Latency(1 month)
- Integrated Relaxation Pressure.(1 month)
- Chicago Classification(1 month)
- Visual analogue scale - cough severity(1 month)
- St. George's Respiratory Questionnaire(1 month)
- Lower Oesophageal Sphincter Pressure(1 month)
- Hull Airway Reflux questionnaire(1 month)
- MRC dyspnoea scale(1 month)
- COPD Assessment test (COPD patients only)(1 month)
- Relationship between oesophageal motility and symptoms(1 month)