CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
standard treatment +1 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02640430
NCT02640430N/ACompleted

A Preliminary Randomized Trial of the FreeAspire Versus PEP-bottle After Acute Exacerbation in COPD Patients With Mucus Hypersecretion and Decreased Cough Efficiency.

Maugeri Foundation·interventional·Posted Dec 29, 2015·Updated Apr 11, 2019

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesItaly, Switzerland
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 29, 2015
Enrollment StartOct 1, 2016
Primary CompletionOct 1, 2018
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.5 years ago

Interventions

standard treatmentdevice

20 minutes, twice a day for 10 sessions

Free Aspiredevice

20 minutes, twice a day for 10 sessions