Hyaluronic Acid in Acute Exacerbation of COPD - Duration Of Noninvasive Assistance (HAEC-DONA)

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: HMW-HA; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00128
      • Università Campus Biomedico di Roma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indices of NIV efficacy over one week of treatment	measures of effectiveness of ventilation in a week of treatment	7 days

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Raffaele Antonelli Incalzi, MD, Università Campus Biomedico di Roma

Publications and helpful links

General Publications

• Galdi F, Pedone C, McGee CA, George M, Rice AB, Hussain SS, Vijaykumar K, Boitet ER, Tearney GJ, McGrath JA, Brown AR, Rowe SM, Incalzi RA, Garantziotis S. Inhaled high molecular weight hyaluronan ameliorates respiratory failure in acute COPD exacerbation: a pilot study. Respir Res. 2021 Feb 1;22(1):30. doi: 10.1186/s12931-020-01610-x.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 15.1(15PT).15 ComEt-CBM; ES102605 (Other Grant/Funding Number: NIEHS grant number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO