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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Placebo; Drug: HMW-HA

• Registration Number: NCT02674880
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Study Start: 2016-03
• Primary Completion: 2019-01
• Study Completion: 2019-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cumulative time on NIV	Day 1-10	Cumulative duration of NIV in hours during the enrollement

Secondary Outcome Measures

Name	Time	Method
Rate of decline of time on NIV	Day 1-10	rapidity of weaning from NIV

Trial Locations

Locations (1)

Università Campus Biomedico di Roma; 🇮🇹 Roma, RM, Italy