Efficacy of Inhaled Budesonide-Formoterol Combination in Post-Infectious Acute Cough A Multicentric Double Blind Randomized Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 3
- 主要终点
- i) To compare the reduction in mean cough score from baseline evaluated at 4th day, 8th day and 14th day of therapy in the add-on inhaled ICS+ LABA group versus the add-on inhaled placebo group
研究概览
简要总结
This study is a multi-centric, double-blind, randomized controlled trial aiming to assess the efficacy of an inhaled LABA-ICS (Long-Acting Beta-Agonist and Inhaled Corticosteroid) combination in patients suffering from post-infectious acute cough. A total of 158 patients will be enrolled and randomly assigned in a parallel-arm design to receive either the inhaled LABA-ICS combination or a placebo, in addition to the standard of care. The trial’s primary outcomes are the reduction in mean cough score from baseline, evaluated on the 4th, 8th, and 14th days of therapy, and the overall improvement in quality of life at 14 days post-treatment initiation, comparing the LABA-ICS group to the placebo group. This investigator-initiated academic trial aims to determine whether the LABA-ICS combination offers greater symptomatic relief and enhanced quality of life for patients with post-infectious acute cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Clinically diagnosed as post-infectious acute cough (duration of cough lasting less than 21 days) •Minimum duration of cough / day of symptoms should be 7 days •Having Acute Cough Symptom Score (CSS)10 more than ≥ 4 at inclusion •Age between 18-65 years, all sexes •Willing to give written informed consent.
排除标准
- •â€¢Those having at least one documented episodes of asthma requiring systemic (i.e., oral, intravenous, or intramuscular) or inhalational corticosteroids in past •Previous history suggestive of bronchial asthma (like history of previous wheezing or episodic shortness of breath) •Present episode of Pneumonia: Culture positive or X ray Chest showing consolidation •Other parenchymal lung disorders as depicted from history or seen in X ray Chest •Past H/O atopy and prominent allergic rhinitis •History or pre-existing evidence of any lung disease •Any previous history of exertional shortness of breath with MMRC scale more than or equal to 1 •History taking and clinical examination revealing other chronic diseases presenting with cough e.g. congestive cardiac failure, kidney disease with volume overload, gastro-oesophageal reflux requiring treatment •Evidence showing immunocompromised status •Evidence of any significant organic dysfunction •Patients already on inhalational steroid or systemic steroid for existing systemic disease •Uncontrolled systemic disease or pregnancy based on initial history •Those receiving peripheral acting cough suppressants, central acting cough suppressants, or bronchodilator cough syrup for more than last two days will be excluded.
结局指标
主要结局
i) To compare the reduction in mean cough score from baseline evaluated at 4th day, 8th day and 14th day of therapy in the add-on inhaled ICS+ LABA group versus the add-on inhaled placebo group
时间窗: 14 days
ii) To compare the overall improvement in quality-of-life from baseline, at 14 days post-treatment initiation, in both groups
时间窗: 14 days
次要结局
- i) To compare the requirement for rescue therapy for acute cough in both groups
- ii) To access the nature and severity of adverse events associated with add-on ICS-LABA therapy
- iii) To compare the requirement for hospital admissions for the ongoing episode of post-infectious acute cough, in both groups (when followed till 30 days of cough-related symptom onset)(30 days)
研究者
Dr Arpit Kumar Saha
Shantiniketan Medical college