NCT02674880

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

2.8 years

First QC Date

February 2, 2016

Last Update Submit

January 24, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Cumulative time on NIV

    Cumulative duration of NIV in hours during the enrollement

    Day 1-10

Secondary Outcomes (1)

  • Rate of decline of time on NIV

    Day 1-10

Other Outcomes (1)

  • Indices of NIV efficacy over one week of treatment

    7 days

Study Arms (2)

HMW-HA

EXPERIMENTAL

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

Drug: HMW-HA

Placebo

PLACEBO COMPARATOR

5 ml of saline via nebulizer b.i.d.

Other: Placebo

Interventions

HMW-HADRUG

Aerolized administration b.i.d.

Also known as: Yabro
HMW-HA
PlaceboOTHER

Standard therapy

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Respiratory arrest or the need for immediate intubation
  • Upper airways obstruction
  • Facial trauma
  • Inability to cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Campus Biomedico di Roma

Roma, RM, 00128, Italy

Location

Related Publications (1)

  • 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.

    PMID: 33517896DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raffaele Antonelli Incalzi, MD

    Università Campus Biomedico di Roma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professore Ordinario, Settore scientifico MED/09

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 5, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2019

Study Completion

September 1, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)