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| ID | Type | Description | Link |
|---|---|---|---|
| ES102605 | Other Grant/Funding Number | NIEHS grant number |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMW-HA | Experimental | HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer b.i.d. |
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| Placebo | Placebo Comparator | 5 ml of saline via nebulizer b.i.d. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMW-HA | Drug | Aerolized administration b.i.d. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative time on NIV | Cumulative duration of NIV in hours during the enrollement | Day 1-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of decline of time on NIV | rapidity of weaning from NIV | Day 1-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Indices of NIV efficacy over one week of treatment | measures of effectiveness of ventilation in a week of treatment | 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raffaele Antonelli Incalzi, MD | Università Campus Biomedico di Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Campus Biomedico di Roma | Roma | RM | 00128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33517896 | Derived | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Placebo | Other | Standard therapy |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |