Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Self-Administered High Frequency Chest Wall Oscillation Technique for Mucus Clearance in COPD: An Exploratory Pilot Project Using the SMARTVEST Device
Patients with Chronic obstructive pulmonary disease (COPD) tend to have cough, excess mucus
production and breathlessness as cardinal features. The excess mucus production often leads
to frequent infections, exacerbations and poor quality of life. Mucociliary clearance may
have an impact on improving symptoms, exercise tolerance, quality of life and reduce
exacerbations.
High frequency chest wall oscillation(HFCWO) devices use percussion to the chest wall
delivered from a pump through a close fitting inflatable vest. This technique has been shown
to enhance mucus clearance in patients with cystic fibrosis and Bronchiectasis. This pilot
study was designed to explore the feasibility, tolerance and effectiveness of the HFCWO in
patients with advanced COPD.
1.1 Background
Chronic obstructive pulmonary disease (COPD) is a major health problem across the world and
its medical, societal and economic impacts continue to grow. COPD is characterized by
chronic obstruction of expiratory flow affecting peripheral airways, associated with chronic
bronchitis (mucus hypersecretion with goblet cell and submucosal gland hyperplasia) and
emphysema (destruction of airway parenchyma), together with fibrosis and tissue damage, and
inflammation of the small airways1. The beneficial effects of smoking cessation in slowing
the decline in lung function and the progression of disease have been clearly established.
Whether other factors such as mucus hypersecretion, respiratory infections and airway
hyper-reactivity contribute to disease progression independent of cigarette smoking is still
being debated2.
Patients with COPD are often distressed by mucus hypersecretion which is one of the
hallmarks of the disease but little is known about the impact of current therapies on mucus
hypersecretion due to the logistical challenges of objectively quantifying mucus in clinical
studies 3. Mucus hypersecretion occurs as a direct result of airway inflammation.
Neutrophils that die by necrosis disgorge proteases and reactive oxygen species into the
lumen. It is concluded that neutrophil death via necrosis leads to the high concentrations
of free neutrophil elastase and reactive oxygen species in the sputum of patients with
airway neutrophilia and mucus hypersecretion. Inflammatory cells (neutrophils), molecules
(neutrophil elastase and reactive oxygen species), signaling pathways (EGFR), and cellular
processes (neutrophil necrosis) contribute to mucus hypersecretion in COPD4.
Mucus hypersecretion leads to increased work of breathing, reduced exercise tolerance,
deteriorating lung function and increases dyspnoea and cough. Often the mucus hypersecretion
also interferes with nocturnal sleep and has a further negative impact on health related
quality of life. Combined mucus hypersecretion, reduced clearance, and impairment of the
lung defence mechanisms explain why COPD patients even with stable condition, carry
potential respiratory pathogens in significant concentration, paving the way for infection
and acute exacerbations of COPD5;6. In the natural history of COPD chronic mucus
hypersecretion is thought to be linked to the accelerated decline of forced expiratory
volume in one second (FEV1)5 7 .
Although mucoactive drugs (which improve the ease of mucus clearance) may be effective in
mucus hypersecretion, the uncertainty surrounding their effectiveness, due primarily to the
relative lack of evidence from randomised controlled trials and an uncertainty from
epidemiological studies linking mucus hypersecretion with mortality8-11, have led to their
poor diffusion and adoption in international guidelines 7. However, in combination with
newer therapeutic strategies currently in research and development phase targeting airway
inflammation and thus reducing mucus hypersecretion, there is a renewed interest in
re-evaluating mucus clearance strategies in improving HRQL, exacerbations and morbidity
associated with COPD 12;13.
Airway clearance forms a vital part the management of patients with CF14, Bronchiectasis and
neuro-muscular diseases15 and has a positive impact on lung function, infection rate and
mortality16;17. Individually tailored chest physiotherapy18 with forced expiratory
manoeuvres is often considered the gold standard in airway clearance19, although
self-administered techniques may be equally effective20 and preferred by patients17;21.
Self-administered airway clearance techniques using devices which create a turbulent airflow
thus encourage shearing of mucus from bronchial wall, have shown promise in improving HRQL
and function in COPD patients22.
High frequency chest wall oscillation (HFCWO)23 is known to reduce respiratory rate but
improve ventilation in patients with COPD24 and CF25. Experimental results suggest that
shearing at the air-mucus interface could be a significant factor in the enhanced tracheal
mucus clearance during HFCWO26. Unlike in CF patients who often have greater support from
family members and show high levels of motivation and thus compliance in adhering to
self-administered airway clearance techniques, COPD patients have low motivation and poor
compliance. Thus self-administered techniques for mucosal clearance may be less effective in
clinical settings away from dedicated research programs. Thus the HCFWO may offer a more
passive modality of airway clearance with consequently higher compliance, if found to be
equally effective and well-tolerated in this group of patients. If HFCWO is shown to improve
HRQL, symptoms and exercise tolerance then it may have a significant role in reducing
exacerbations and hospital admissions as well as allowing effective management in the
community setting. The cost benefit of such improvements will need to be explored in larger
studies in the future.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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