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临床试验/NCT05548036
NCT05548036招募中不适用

A Feasibility Randomised Control Trial (RCT) of Aerobika TM Verses Active Cycle of Breathing Technique (ACBT) in People With Chronic Obstructive Pulmonary Disease (COPD)

Carwyn Bridges2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
2
主要终点
To test the null hypothesis there is no difference in Leister Cough Questionnaire between groups at 3 months

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) is a common preventable and treatable respiratory condition. Its main symptoms include, breathlessness, cough and frequent chest infections. Many people with COPD struggle with excessive production of sputum, resulting in more hospital admissions and worse symptoms affecting quality of life.

Guidelines suggest techniques to help clear sputum but there is not strong evidence behind these. In particular we don't know how effective cough clearance techniques are and indeed if any are better than others. This study will recruit people admitted to hospital with an exacerbation of COPD who have excessive sputum and randomise them to receive a hand-held airways clearance device or chest physiotherapy exercises. We will compare symptoms, quality of life, treatment burden and hospital admissions over the following year.

详细描述

Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease and in the UK around 80% is caused by smoking. Respiratory symptoms include breathlessness, cough and excess sputum production. COPD is associated with significant healthcare burden and increased mortality and morbidity (GOLD, 2020).

Exacerbations are acute periods of worsening symptoms above normal day to day variation, leading to increased treatment and often emergency hospital admissions placing a significant burden on the health care system and are associated with a worse QoL and poorer long-term prognosis. (Ekberg-Aronsson et al., 2005). COPD causes over 30,000 deaths in the UK annually, and is the second commonest cause of hospital admission (NICE, 2018).

Patients with a chronic bronchitis phenotype have worse health status and COPD Assessment Test (CAT) score, experience more frequent exacerbations and received more pharmacological treatment than other phenotypes (Cosio et al., 2016).

Airways clearance appears an important adjunctive treatment in those with a chronic bronchitis phenotype of COPD who struggle with mucus hypersecretion (Svenningsen et al., 2016) but the evidence is not strong. In particular there are no well-designed studies (Randomised control trials-RCT's) that compare different types of cough clearance techniques against medication alone or against each other.

Burudpakdee et al. (2017) in a retrospective Canadian database analysis enrolled 405 participants into two crossmatch groups over a two-year period, found that provision of Oscillatory Positive Expiratory Pressure (OPEP) Aerobika™ devices were associated with a 19% re-exacerbation rate, compared with a 28% exacerbation rate in those receiving standard care (p=0.01). They suggested Aerobika™ may be a cost-effective way of reducing emergency department visits and costs associated with unplanned admissions. However, as this was a retrospective study, the data used to make these assumptions may lack clinical detail and be prone to reporting and selection bias.

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
None

盲法说明

Randomised at recruitment then due to the nature of the intervention masking is not viable

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to hospital (current inpatient) or recent exacerbation treated in the community within 14 days with systemic steroids and/or antibiotics
  • Male or Female, aged 40-90 years
  • A diagnosis of COPD
  • Greater than 10 pack year history
  • FEV1 /FVC Ratio <0.70 at any time point in the last 5 years
  • Regular sputum production (most days for at least 3 months)
  • Prescribed optimal pharmacological treatment
  • Able to provide informed consent
  • CAT score >15

排除标准

  • Contraindications to OPEP, recent hemoptysis or pneumothorax
  • Unable to use OPEP (manual dexterity)
  • Unstable cardiac conditions in the opinion of the clinical team
  • Life expectancy less than 12 months.

结局指标

主要结局

To test the null hypothesis there is no difference in Leister Cough Questionnaire between groups at 3 months

时间窗: 3 months

LCQ is a validated cough questionnaire. It consists of a 19-part questionnaire with a Likert scale scoring system between 1-7 measurements of physical, psychological, and social domains.

次要结局

  • To test the null hypothesis there is no difference in CAT between groups at 3 months(3 months)

研究者

发起方
Carwyn Bridges
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carwyn Bridges

Hon research fellow

Hywel Dda Health Board

研究点 (2)

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