At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Preliminary Randomized Trial of the FreeAspire Versus PEP-bottle After Acute Exacerbation in COPD Patients With Mucus Hypersecretion and Decreased Cough Efficiency.
In Brief
A clinical study evaluating standard treatment and Free Aspire for COPD. Completed, enrolled 40 participants across 2 sites in 2 countries.
Detailed Summary
BACKGROUND: Studies have shown that COPD patients with bronchial hypersecretion have increased risk of acute exacerbations. FREE ASPIRE is an electro-medical device which removes bronchopulmonary secretions noninvasively, without using a suction catheter and without generating airway pressure. AIM: To compare FREE ASPIRE activity with the traditional treatment using PEP-bottle in the clearance of bronchial secretions in COPD patients METHODS: Forty severe and very severe COPD patients with mucus and reduced cough will be evaluated. Group comparison will be made between Intervention group using VAKÜM system (Free Aspire®), and Control group using traditional treatment with PEP-bottle over 10 daily sessions (20 minutes twice a day). Primary outcomes are changes in arterial blood gases exchanges, in perceived dyspnea and in symptom of bronchial encumbrance. EXPECTED RESULTS: A higher significant reduction of the perceived dyspnea and of perceived bronchial encumbrance is supposed in the Intervention group. Additional benefits among the secondary outcomes are also hypothesized in the same group.
Study Details
Timeline
Interventions
20 minutes, twice a day for 10 sessions
20 minutes, twice a day for 10 sessions