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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-09-30

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).

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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HMW-HA

HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer b.i.d.

Group Type EXPERIMENTAL

HMW-HA

Intervention Type DRUG

Aerolized administration b.i.d.

Placebo

5 ml of saline via nebulizer b.i.d.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Standard therapy

Interventions

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HMW-HA

Aerolized administration b.i.d.

Intervention Type DRUG

Placebo

Standard therapy

Intervention Type OTHER

Other Intervention Names

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Yabro

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