Chronic Obstructive Pulmonary DiseasePhase 2HAEC-DONANCT02674880
Hyaluronic Acid in Acute Exacerbation of COPD - Duration Of Noninvasive Assistance
A Phase 2 study testing HMW-HA in people with Chronic Obstructive Pulmonary Disease, run by Campus Bio-Medico University at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- HMW-HA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Respiratory arrest or the need for immediate intubation
- Upper airways obstruction
- Facial trauma
- Inability to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- HMW-HA, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMW-HADrug
Also called Yabro
Aerolized administration b.i.d.
PlaceboOther
Standard therapy
| Study group | Role | What they receive |
|---|---|---|
| HMW-HA | Experimental | HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer b.i.d. Receives: Drug: HMW-HA |
| Placebo | Placebo comparator | 5 ml of saline via nebulizer b.i.d. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative time on NIV
Cumulative duration of NIV in hours during the enrollement
Measured: Day 1-10
Secondary outcomes (1)
Rate of decline of time on NIV
rapidity of weaning from NIV
Measured: Day 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Raffaele Antonelli Incalzi, Campus Bio-Medico University
- Investigators
- Raffaele Antonelli Incalzi, MD, Principal investigator, Università Campus Biomedico di Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674880
- Sponsor's protocol ID
- 15.1(15PT).15 ComEt-CBM
- Other IDs
- ES102605
- Acronym
- HAEC-DONA
- Status last verified
- Jan 2020
- First submitted
- 2 Feb 2016
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 33517896
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02674880
- Acronym / sponsor ID
- HAEC-DONA / 15.1(15PT).15 ComEt-CBM
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMW-HA | Experimental | Drug: HMW-HAHMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer b.i.d. |
| Placebo | Placebo comparator | Other: Placebo5 ml of saline via nebulizer b.i.d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Respiratory arrest or the need for immediate intubation
- Upper airways obstruction
- Facial trauma
- Inability to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMW-HAAlso: YabroAerolized administration b.i.d. | Drug | HMW-HA |
| PlaceboStandard therapy | Other | Placebo |
Primary outcome
Cumulative time on NIV
Time frame: Day 1-10
Cumulative duration of NIV in hours during the enrollement
1 secondary outcome
Rate of decline of time on NIV
Time frame: Day 1-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 33517896Galdi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Antonelli Incalzi, MD principal investigator
Università Campus Biomedico di Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HMW-HA in people with Chronic Obstructive Pulmonary Disease, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative time on NIV (time frame: Day 1-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02674880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.