J44.9 J47 J41 J44.8
Conditions
Interventions
Group 1: Use of Simeox 1-3 times a day for 12-15 minutes each time on 20 consecutive days.
Patients fill out validated (SGRQ, CAT, mMRC) and study-specific questionnaires (sputum color) before and a
Sponsors
Physio Assist
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients with COPD (J44.9) or bronchiectasis (J47) or chronic bronchitis (J41, J44.8) WITH chronic mucus hypersecretion 2. Clinically stable on current airway therapy (i.e. among some background treatments: bronchodilators, inhaled corticoïds, oral antibiotics, mucoactive agents) for at least 4 weeks prior to study enrolment 3a Compliant with usage of Nebulizers with NaCl (in combination or not with other drugs) for at least past 3 months or a documented historic therapy trial, unless there is a documented contraindication, intolerance or inability to use nebulizers properly. 3b Compliant with usage of a PEP/ oPEP device for at least past 3 months or a documented historic therapy trial, unless there is a documented contraindication, intolerance or inability to use PEP/oPEP devices properly. 4. 18-90 years 5. Computer/tablet/smartphone access plus ability to use video calls
Exclusion criteria
Exclusion criteria: At the investigator's discretion after risk analysis of Simeox therapy: 1. Inability to cough forcefully and independently. 2. Neuromuscular disease with respiratory muscle weakness 3. Actively requiring device assistance for inspiration (e.g., ventilatory assistance with endotracheal tube, tracheostomy tube, or ventilated with a mask) 4. Unstable cardiovascular disease (recent heart attack, unstable angina, uncontrolled arrhythmias, unstable heart failure) 5. Hemodynamic instability 6. Known history of recent pneumothorax or pneumomediastinum 7. Uncontrolled gastroesophageal reflux disease 8. Recent cardiothoracic surgery, acute severe lung injury or acute/gross hemoptysis 9. Airway at risk of aspiration 10.Severe restrictive disease (TLC<60%, if TLC not available check if FVC<60%) 11.Severe upper airways muscle weakness (oral/oropharyngeal, inspiratory) 12.Inspiratory muscle weakness with inability to tolerate increased work of breathing Further exclusion criteria: 13. Any infection that resulted in hospital admission for = 24 hours and/or treatment with IV or IM antibiotics within 4 weeks prior enrolment 14. Use of Simeox during the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change from baseline in health-related quality of life after 20 days of Simeox use. Measured via SGRQ before and after 20 days of Simeox use. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured via questionnaires/diaries: - change from baseline in SGRQ domains (symptom, impact and activity) - change in CAT (COPD assessment test) - change in mMRC (dyspnea scale) - change of sputum production - change of sputum color - change of chest congestion - Self-reported device adherence (number of sessions per day and per week, % of patients with 1 or more sessions/day) - Intended continuation with Simeox therapy after the study (%) - Patients’ rating of Simeox, PEP/oPEP and nebulizers - Patients´ view on usability of the device - % drop out during or after Simeox training - % side effects that led to discontinuation of Simeox therapy | — |
Countries
Germany
Contacts
Public ContactSusanne Neubert
RQM+ (Germany) - CRO
Outcome results
None listed