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

Chronic Obstructive Pulmonary Disease Clinical Trial

— HAEC-DONA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674880
• Other study ID #: 15.1(15PT).15 ComEt-CBM
• Secondary ID: ES102605
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: September 2019

Study information

• Verified date: January 2020
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• HMW-HA
Aerolized administration b.i.d.

Other:
• Placebo
Standard therapy

Locations

Country	Name	City	State
Italy	Università Campus Biomedico di Roma	Roma	RM

Sponsors (2)

Lead Sponsor	Collaborator
Campus Bio-Medico University	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Indices of NIV efficacy over one week of treatment	measures of effectiveness of ventilation in a week of treatment	7 days
Primary	Cumulative time on NIV	Cumulative duration of NIV in hours during the enrollement	Day 1-10
Secondary	Rate of decline of time on NIV	rapidity of weaning from NIV	Day 1-10