Indomethacin for Refractory Chronic Cough: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change from Baseline Cough Severity
研究概览
简要总结
Chronic cough is a common complain of patients in respiratory clinic and its global prevalence was up to 9.6%. Persistent cough of unexplained origin is a significant health issue that occurs in up to 5% to 10% of patients seeking medical assistance for a chronic cough and from 0% to 46% of patients referred to specialty cough clinics. Previous studies showed that sputum prostaglandin D2( PGD2) and prostaglandin E2 (PGE2) concentrations were significantly higher in chronic cough. And some research showed that Inhaled PGE2 /PGF2α /PGD2 / PGI2/ 6-oxo-PGF1a could induced cough. And PGE2 /PGF2α/PGI2/thromboxane A2 (TXA2) also increased the sensitivity of the cough reflex. All these five primary prostaglandins were synthesized though the metabolism of arachidonic acid via the cyclooxygenase pathway. Indomethacin is a strong inhibitor of cyclooxygenase , which decrease the level of prostaglandins in airway. The investigator's preliminary study showed that indomethacin could relieve cough and improve cough sensitivity of some patients with refractory cough. Therefore this randomized, double-blind, placebo-controlled trial were designed to investigate whether indomethacin can relive cough in patients with refractory cough and to explore the possible mechanism of indomethacin in improving cough in patients with refractory cough.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1）18 years old ≤ age ≤ 60 years old, male or female; 2）Chronic cough lasting more than 8 weeks as the sole or predominant symptom, without abnormalities on chest radiograph; 3）Chronic cough remains after investigation and supervised therapeutic trial(s) conducted according to "Clinical Practice Guidelines for Diagnosis and Management of Cough (2015)" 4）Cough VAS (0-100mm) ≥ 30 mm
排除标准
- •Patients had any contraindications to indomethacin;
- •Patients had active respiratory disease (such as chronic obstructive pulmonary Disease or untreated asthma), or moderate or above obstructive or restrictive or mixed pulmonary ventilation dysfunction;
- •Patients had a respiratory tract infection in the month before randomization;
- •Patients were taking an angiotensin-converting enzyme inhibitor;
- •Patient were pregnant or breastfeeding, or had impaired kidney function;
- •Current and recent smokers (<6 months' abstinence), or ex-smokers with more than 20 pack-years (20 cigarettes per pack).
研究组 & 干预措施
indomethacin treatment group
indomethacin (75mg, bid) + omeprazole (20mg, qd)
干预措施: indomethacin (Drug)
indomethacin treatment group
indomethacin (75mg, bid) + omeprazole (20mg, qd)
干预措施: Omeprazole (Drug)
placebo treatment group
placebo (75mg, bid) + omeprazole (20mg, qd)
干预措施: Placebo (Drug)
placebo treatment group
placebo (75mg, bid) + omeprazole (20mg, qd)
干预措施: Omeprazole (Drug)
结局指标
主要结局
Change from Baseline Cough Severity
时间窗: 1, 3, 7, 10, 14, 21day
Outcome measure: Cough visual analogue scales (Cough VAS). Score range: 0-100mm (0 mean no cough, 100 represent that cough is the most severe in his/her life. Scoring higher on cough VAS mean more severe cough he/she has. )
Change of cough-specific-quality-of-life
时间窗: 1, 14, 21 day
Outcome measure: Leicester Cough Questionnaire (LCQ). Score range: 3-21 (Higher values represent a better outcome.)
次要结局
- frequency of patients'coughs(1, 7, 14 day)
- laryngeal dysfunction score(1, 7, 14 day)
- cough reflex sensitivity(1, 7, 14, 21 day)
研究者
Kefang Lai
professor
The First Affiliated Hospital of Guangzhou Medical University