Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Clinical effect on coughing
研究概览
简要总结
Randomized, double-blind, placebo-controlled study comparing formoterol-beclometason 12/200 mcg BID versus placebo to evaluate the clinical effect on coughing in patients with non-cystic fibrosis (non-CF) bronchiectasis, native to inhaled corticosteroid (ICS) therapy and no history of asthma or chronic obstructive pulmonary disease (COPD)
详细描述
In the management of non-CF bronchiectasis, bronchodilator treatment (LABA)and use of inhaled corticosteroids (ICS) is still a matter of debate. Previous studies have claimed beneficial effects of ICS (with or without bronchodilator), such as improvement of the HRQL, a reduction in daily sputum volume and/or exacerbation frequency. However, in all previous studies there was no clear exclusion of patients with asthma or COPD, or no use of placebo. The current study will be the first study evaluating the effect of ICS/LABA treatment in non-CF bronchiectasis excluding patients with asthma and COPD.
This is a prospective double-blind randomized controlled trial comparing Formoterol-beclomethasone 12/200 mcg BID versus placebo to evaluate the reduction in cough measured by the Leicester cough questionnaire. Secondary objectives are the improvement of health-related quality of life and symptoms, reduction in sputum production, pulmonary function (FEV1) and the frequency of exacerbation. Furthemore, we will assess the inflammatory response in serum and sputum.
After a wash-out period of 1 month, eligible subjects will be randomized to treatment with formoterol-beclomethasone or matching placebo. All subjects will be treated with the regimen of medication for 3 months. An end-of-study (EOS) visit will be performed after completion of the follow-up period.
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)
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
- •Symptomatic patient (wheezing, cough and dyspnoea);
- •Proven and documented diagnosis of BE by high resolution computed tomography ;
- •Stable pulmonary status as indicated by FEV1 (percent of predicted) ≥30%
- •Stable clinically phase (ie, subjects free from acute exacerbation for at least 6 weeks prior to the start of the study);
- •Stable regimen of standard treatment as chronic treatment for BE, at least for the past 4 weeks prior to screening. And/or macrolides if used as chronic treatment for BE at least for the past 6 months prior to screening;
- •Coughing on the majority of days for more than 8 weeks;
- •Ability to follow the inhaler device instructions;
- •Ability to complete questionnaires;
- •Written informed consent.
排除标准
- •Possible asthma according to the definition of the Global Initiative for Asthma (GINA);
- •Positive histamine provocation test
- •Known intolerance for ICS or LABA;
- •Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
- •Expected to die within 72 hours after enrolment;
- •Cigarette smoking history of > 10 pack-years or current smokers;
- •Other cardiopulmonary conditions (other than bronchiectasis) that could modify spirometric values.
研究组 & 干预措施
Formoterol-beclomethasone
Formoterol (fumarate dehydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler.
干预措施: Formoterol-beclomethasone (Drug)
Placebo
Matching placebo (identically package) administered BID
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical effect on coughing
时间窗: 3 months
Using the Leicester Cough Questionnaire (LCQ) at baseline and 3 months. The LCQ is a valid, repeatable 19 item self-completed quality of life measure of chronic cough which is responsive to change. Score range: 19-133 (Higher values represent a better outcome.)
次要结局
- Dyspnea score(3 months)
- Quality of life in patient with bronchiectasis(3 months)
- Sputum production(3 months)
- Incidence of Adverse Events [Safety and Tolerability]).(3 months)
- Pulmonary function(3 months)
- Exacerbation frequency(3 months)
- Sputum culture(3 months)
研究者
Menno M. van der Eerden
Pulmonary physician, MD, PhD
Erasmus Medical Center