The effectiveness of an Oscillating Positive Expiratory Pressure (OPEP) Therapy on respiratory symptoms in patients with COPD/chronic bronchitis with excess mucus in daily clinical practice

Chronic mucus hypersecretion and impaired mucociliary clearance are hallmark
features of the chronic bronchitis phenotype of Chronic Obstructive Pulmonary
Disease (COPD). Chronic cough and excess mucus production have been found to be
associated with patient-related outcomes such as exacerbations,
hospitalisations, lung function decline and increased mortality. Therefore,
airway clearance techniques like Oscillating Positive Expiratory Pressure
(OPEP) therapy might play an important role in the management of patients with
COPD or chronic bronchitis with chronic sputum production. However, evidence
for the routine use of these devices in clinical practice is lacking.

To evaluate the effect of OPEP use on respiratory symptoms in patients with
COPD or chronic bronchitis with excess mucus in daily clinical practice.

A prospective randomised, double-blind, controlled trial.
The study will consist of two visits, a baseline visit and a follow up visit (3
months later).
At both visits lung function will be measured, and patients will be asked to
fill out questionnaires with regard to symptoms (CCQ), cough symptoms (LCQ),
health-related quality of life (SGRQ). At 6 weeks patients will fill out the
CCQ questionnaire to be able to determine the timing of the effect of the OPEP
device. In addition, at follow-up patients will be asked to rate their change
in health and in ability to cough up sputum in the last 3 months (since the
baseline visit) on a global rating of change questionnaire. Data on
exacerbations, hospitalisation due to COPD, adherence with therapy and
satisfaction with the device will be collected at the follow-up visit. Patients
will be randomised at baseline to either the intervention group (using a
hand-held mechanical OPEP device) or the control group (using the sham version
of the hand-held device). Patients will be instructed to use the OPEP device
for 3 months twice daily for 10 minutes.

Patients will be allocated either to the intervention group (using a hand-held
mechanical oPEP device) or the control group (using the sham version of the
hand-held device). Patients in both groups will be instructed (according to the
standard guideline) to use the device twice daily for 10 minutes for three
months.

Participating in this study does not involve any risk for patients. The OPEP
device used in this study is registered and already being precribed in usual
care and the measurements are not invasive (questionnaires) or routine
measurements in these patients (spirometry). Patients will visit the hospital
two times and fill out questionnaires. After 6 weeks patients will be send a
short version of the questionnaire (symptoms and adherence) and after filling
out these questionnaire patients may return the questionnaire in a prestamped
envelope.
Patients are instructed to use the OPEP system for 3 months twice daily for 10
minutes. This is the standard use as prescribed in clinical practice. However,
patients in the control group will use an OPEP system without functional
mechanisms. In our opinion the benefits of including a control group using a
sham device (by preventing bias) outweights the disadvantages (asking patients
twice daily for 10 minutes to use the device). Since we inform patients well
and explain the reason for this, patients can consider this issue before they
agree to participate. Although we realise that this might influence
participation rate and adherence we emphasise the need for high quality studies
in this area. This study might improve the management of patients with COPD or
chronic bronchitis with excess mucus, since it will reveal the beneficial value
of OPEP Therapy in this patient population in daily clinical practice.