Clinical trial NCT02674880: Hyaluronic Acid in Acute Exacerbation of COPD - Duration Of Noninvasive Assistance
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2016-02-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative time on NIV
timeFrame: Day 1-10
Secondary outcomes:
measure: Rate of decline of time on NIV
timeFrame: Day 1-10
Other outcomes:
measure: Indices of NIV efficacy over one week of treatment
timeFrame: 7 days
Locations:
city: Roma
country: Italy
facility: Università Campus Biomedico di Roma
state: RM
Study officials:
affiliation: Università Campus Biomedico di Roma
name: Raffaele Antonelli Incalzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.