Hyaluronic Acid in Acute Exacerbation of COPD - Duration Of Noninvasive Assistance

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Use of High-molecular Weight Hyaluronan in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Diseases Treated With Non-invasive Ventilation: Feasibility and Outcomes

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: HMW-HA
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years of age or older Admitted for respiratory failure primarily due to COPD exacerbation Requiring non-invasive ventilation Respiratory distress, as evidenced by moderate-to-severe dyspnea and use of accessory muscles of respiration Hypercapnic respiratory failure High respiratory rate Exclusion Criteria: Respiratory arrest or the need for immediate intubation Upper airways obstruction Facial trauma Inability to cooperate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HMW-HA<br>HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer b.i.d. | Drug: HMW-HA<br>* Aerolized administration b.i.d.<br>* Other names: Yabro;|
| Placebo Comparator: Placebo<br>5 ml of saline via nebulizer b.i.d. | Other: Placebo<br>* Standard therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative time on NIV | Cumulative duration of NIV in hours during the enrollement | Day 1-10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of decline of time on NIV | rapidity of weaning from NIV | Day 1-10 |