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More info
You can access this
clinical trial
if you have
COPD
and you are
between 40 and 85
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Device: standard treatment
  • Device: Free Aspire

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02640430. The sponsor of the trial is Maugeri Foundation and it is looking for 40 volunteers for the current phase.
Official trial title:
A Preliminary Randomized Trial of the FreeAspire Versus PEP-bottle After Acute Exacerbation in COPD Patients With Mucus Hypersecretion and Decreased Cough Efficiency.