Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Use of High-molecular Weight Hyaluronan in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Diseases Treated With Non-invasive Ventilation: Feasibility and Outcomes
The objective of this study is to test the effect of High Molecular Weight Hyaluronic Acid (HMW-HA) on Non Invasive Ventilation (NIV) effectiveness in patients admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
The objective of this study is to test the effect of HMW-HA on NIV effectiveness in patients
admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of
COPD. The design is a parallel-arm, single-blind, placebo-controlled randomized clinical
trial. Eighty patients, aged eighteen years or older, admitted for respiratory failure
primarily due to COPD exacerbation and requiring non-invasive ventilation will be enrolled
and randomized to the study treatment (active or placebo).
All patients will be treated with NIV delivered using a Hamilton C1 ventilator and medical
therapy according to current guidelines (inhaled long-acting b2 agonists, inhaled long-acting
anticholinergic, inhaled and systemic corticosteroids, antibiotics). Patients randomized to
the active intervention group will also receive HMW-HA (Yabro® - 5 ml of saline containing
0.3% hyaluronic acid sodium salt) via nebulizer b.i.d., while patients randomized in the
control group will receive a matching placebo. Patients will be treated until weaning or
until NIV failure, defined as oro-tracheal intubation or death.
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