OPEP Therapy in COPD/chronic bronchitis patients with excess mucus

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”

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27221

Enrollment

Registered

2015-12-13

Start date

2015-12-16

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD chronic bronchitis sputum airway clearance COPD chronische bronchitis sputum mucusklaring

Interventions

Patients will be randomly allocated either to the intervention group (using a hand-held mechanical OPEP device, Aerobika) or the control group (using the sham version of the hand-held device).The sham

Eligibility

Inclusion criteria

Inclusion criteria: Patients with COPD or bronchitis with excessive mucus will be included in this study. Inclusion criteria - Diagnosis: Patients with COPD or chronic bronchitis. - Aged 40 years or older - Excessive mucus

Exclusion criteria

Exclusion criteria: Exclusion criteria - Patiënts with CF - Patients with bronchiectasis - Patients who used OPEP in the past.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the mean CCQ Total score after 3 months.	—

Secondary

Measure	Time frame
The secondary endpoints at 3 months are: - mean subdomain scores of the CCQ, respectively symptoms, mental and functional state. - mean Leicester Cough Questionnaire (LCQ) total and domain scores. - St. George’s Respiratory Questionnaire (SGRQ). - A global rating of change in health status and in ability of coughing up sputum after 3 months will be used to evaluate self-perceived change. - Lung function (spirometry, FEV1, FEV1%pred, FVC, FVC%pred). - Exacerbation rate. - Hospitalisation rate for COPD.	—

Measure

Time frame

The secondary endpoints at 3 months are: - mean subdomain scores of the CCQ, respectively symptoms, mental and functional state. - mean Leicester Cough Questionnaire (LCQ) total and domain scores. - St. George’s Respiratory Questionnaire (SGRQ). - A global rating of change in health status and in ability of coughing up sputum after 3 months will be used to evaluate self-perceived change. - Lung function (spirometry, FEV1, FEV1%pred, FVC, FVC%pred). - Exacerbation rate. - Hospitalisation rate for COPD.

—

Contacts

Public ContactSiebrig Schokker

Longziekten - Martini Ziekenhuis

s.schokker@mzh.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)