Oral Corticosteroids for Post-infectious Cough in Adults: A Double-blind Randomised Placebo-controlled Trial in Swiss Family Practices (OSPIC Trial)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Cough-related Quality of Life (QoL) assessed by the Leicester Cough Questionnaire (LCQ) score
研究概览
简要总结
The purpose of this study is to assess whether a 5-day treatment with orally administered prednisone provides patient-relevant benefits by improving the cough-related QoL of patients with post-infectious cough triggered by an Upper Respiratory Tract Infection (URTI) and seeking care in adult primary care practices. The study aims to describe an efficacy and safety profile for a 5-day prednisone treatment compared to a 5-day course of placebo.
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)
盲法说明
blinded patients, physicians and outcome assessors
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
- •Patients seeing a GP for a dry or productive post-infectious cough (3 to 8 weeks) after Upper Respiratory Tract Infection (URTI)
- •Patients able and willing to give informed consent by themselves and to fill in the LCQ on day 0 with the GP and to answer phone calls from the research staff/study nurse at day 7, 14, and 28, and at 3 months for outcome assessment
排除标准
- •Patients with known or suspected diagnoses associated with cough, such as: pneumonia or suggestive symptoms and signs (abnormal vital signs, i.e. heart rate >100/min, respiratory rate >25/min, fever), allergic rhinitis, sinusitis, bronchial asthma, chronic pulmonary disease (COPD), or gastroesophageal reflux disease,
- •Patients with other chronic disease such as bronchiectasis, cystic fibrosis, cancer, tuberculosis, heart failure.
- •Use of inhaled or oral corticosteroids within the last four weeks
- •Immunodeficiency/immunocompromised state (e.g. cancer chemotherapy, HIV infection, administration of immune-suppressive agents)
- •Pregnancy/ breastfeeding
- •Regular treatment known to be associated with cough (e.g. angiotensin converting enzyme inhibitors)
- •Patients with pharmacotherapy for glaucoma or osteoporosis
- •Experienced fractures due to osteoporosis
- •Patients with uncontrolled diabetes (as deemed by GPs who appraise whether the potential side effects of short-time corticosteroids on glucose levels exceed the hypothesised benefit on cough)
研究组 & 干预措施
Intervention group
Identically looking, numbered and marked medication glass jars with 5 daily doses of 40 mg (2 tablets of 20 mg) of prednisone (intervention group) are provided by General Physicians (GPs) to participants. PREDNISON Galepharm Tabl. 20 mg are manufactured according to Good Manufacturing Practice (GMP)-guidelines.
The prednisone medication is manufactured by Galepharm AG, 8700 Küsnacht (ZH) and packaged and labelled by the Hospital Pharmacy of the University Hospital Basel. The PREDNISON tablets' active substance is Prednisonum; the tablets also contain Excipiens pro compresso. Swissmedic authorization 50821
干预措施: PREDNISON Galepharm Tabl. 20 mg (Drug)
Control group
Identically looking, numbered and marked medication glass jars with 5 daily doses of placebo (control group) are provided by General Physicians (GPs) to participants.
The content of the placebo tablets is as follows: Lactose monohydrate 140 mg, microcrystalline cellulose 68 mg, Croscarmellose sodium 5 mg, Magnesium stearate 2mg. The placebo tablets were manufactured by Apotheke Hotz, Zürichstrasse 176, CH- 8700 Küsnacht.
干预措施: placebo tablets (Drug)
结局指标
主要结局
Cough-related Quality of Life (QoL) assessed by the Leicester Cough Questionnaire (LCQ) score
时间窗: assessment done 14 days after randomisation
The LCQ comprises 19 items and takes 5 to 10 minutes to complete. The LCQ is a validated QoL measurement tool for non-specific cough and assesses the impact of cough on various aspects of life, including emotions, sleeping behaviour, work and relationships. It contains 19 items which are divided over 3 domains: physical (8 items), psychological (7 items) and social (4 items), with a 7-point Likert response scale.
次要结局
- Overall cessation of cough(assessment done 7, 14, 28 days and 3 months after randomization)
- Incidence rate of re-consultations with the treating GP and/or hospitalisations(within 3 months following randomisation)
- Total Adverse Events (number)(within 3 months after randomization)
- Serious Adverse Events (number)(within 3 months after randomization)
- Change in Cough-related QoL assessed by the LCQ score(assessment done at 7 and 28 days and at 3 months after randomisation)