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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674880
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Raffaele Antonelli Incalzi, Campus Bio-Medico University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: HMW-HA Other: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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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 Name: Yabro
Placebo Comparator: Placebo
5 ml of saline via nebulizer b.i.d.
 Other: Placebo
Standard therapy


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative time on NIV [ Time Frame: Day 1-10 ]
    Cumulative duration of NIV in hours during the enrollement


Secondary Outcome Measures :
  1. Rate of decline of time on NIV [ Time Frame: Day 1-10 ]
    rapidity of weaning from NIV


Other Outcome Measures:
  1. Indices of NIV efficacy over one week of treatment [ Time Frame: 7 days ]
    measures of effectiveness of ventilation in a week of treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674880


Locations
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Italy
Università Campus Biomedico di Roma
Roma, RM, Italy, 00128
Sponsors and Collaborators
Campus Bio-Medico University
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Raffaele Antonelli Incalzi, MD Università Campus Biomedico di Roma
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Raffaele Antonelli Incalzi, Professore Ordinario, Settore scientifico MED/09, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT02674880    
Other Study ID Numbers: 15.1(15PT).15 ComEt-CBM
ES102605 ( Other Grant/Funding Number: NIEHS grant number )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes