Azithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Number of patients with a subjective response to treatment
研究概览
简要总结
Idiopathic pulmonary fibrosis (IPF) is a devastating disease with no cure available. Patients suffer from respiratory symptoms including dyspnea and cough. To improve life quality the investigators will test the effects of immunomodulation of macrolides specifically on cough in IPF patients. The investigators hypothesize that immunomodulatory treatment reduces cough frequency and might improve lung function.
详细描述
Background
Idiopathic pulmonary fibrosis is a progressive interstitial lung disease, which ultimately leads to respiratory failure and death. The median survival is 2-3 years and thus comparable to the survival of a malignant disease. Today, there is no cure available. Improvement of quality of life (QoL) is thus a major goal in IPF patients. Cough is a common distressing and debilitating symptom in IPF. Increased cough in IPF patients may be linked to functional upregulation of lung sensory neurones. In addition, cough independently predicts disease progression in IPF patients. Symptomatic treatment options for cough in IPF are limited. Dysregulation of the immune system has been suggested to cause IPF associated cough and treatment trials with immunomodulating agents have been promising. Unfortunately the recently studied medication thalidomide is famous for its side effects and might be apprehensively received by some patients.
Immunomodulatory effects of macrolide treatment in chronic inflammatory diseases as well as reduced cough reflex in animal studies suggest a possible reduction in cough in IPF patients. In addition, in animal in vivo models azithromycin also showed anti-fibrotic properties.
The investigators hypothesize that immunomodulatory treatment of IPF patients with AZT reduces cough frequency and might improve lung function.
Objective
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Idiopathic pulmonary fibrosis; new diagnosis, or known. Diagnosis according to the current guidelines from ATS/ERS for IPF diagnosis, other differential diagnoses ruled out.
- •Clinical symptoms of cough
- •Written informed consent for study participation
- •Exclusion Criteria
- •Previous history of an adverse reaction or allergy on azithromycin or other macrolide or ketolide antibiotics or any other ingredient (e.g. lactose)
- •Evidence of respiratory infection or systemic infection one month before randomisation
- •Known rhythmogenic heart disease
- •Pregnancy or lactation
- •History of non-compliance to medical treatment
- •Current alcohol or drug abuse
- •Active hepatitis, history of hepatitis, other significant liver disease
- •Serum bilirubin > 50 μmol/L
- •Transaminases or alkaline phosphatase elevated > 3x upper limit of normal at baseline
- •Severe renal insufficiency with GFR <10ml/min
- •Concomitant treatment with ergotamines
- •Concomitant treatment with ciclosporin
- •Concomitant treatment with ributin
- •Concomitant treatment with digoxin
- •Change of medication until 4 weeks before randomisation
- •Pirfenidone <3 Mo
排除标准
- 未提供
研究组 & 干预措施
Azithromycin first, Placebo second
Medication with Azithromycin 500mg/d 3x/week p.o. o.d. for 12 weeks or placebo.
干预措施: placebo (Drug)
Azithromycin first, Placebo second
Medication with Azithromycin 500mg/d 3x/week p.o. o.d. for 12 weeks or placebo.
干预措施: azithromycin (Drug)
Placebo first, Azithromycin second
Medication with Azithromycin 500mg/d 3x/week p.o. o.d. for 12 weeks or placebo. Placebo will be capsulated similar to verum and given 3 times a week.
干预措施: azithromycin (Drug)
Placebo first, Azithromycin second
Medication with Azithromycin 500mg/d 3x/week p.o. o.d. for 12 weeks or placebo. Placebo will be capsulated similar to verum and given 3 times a week.
干预措施: placebo (Drug)
结局指标
主要结局
Number of patients with a subjective response to treatment
时间窗: 3 months
Subjective response is defined as a 1.3 unit reduction of cough as measured with the Leicester Cough Score from treatment start to 12 weeks of treatment.
次要结局
- Number of patients with a change in 6 min walking distance(3 months)
- Number of patients with an objective response to treatment(3 months)
- Number of patients with a change in lung function(3 months)
- Number of patients with a change in oxygen saturation(3 months)
- Number of patients with a change in quality of life(3 months)
- Number of patients with changes in oropharyngeal flora(3 months)