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The purpose of the study is to evaluate the safety and efficacy of administering repeated doses of Hyaluronic Acid Inhalation Solution to subjects with Emphysema that have Alpha-1-Antitrypsin deficiency
The study primarily aims to establish desmosine and isodesmosine concentrations in plasma, sputum and urine measured as markers of elastin degradation systemically in the lung and also markers of inflammation and fibrinogen. Assessment of vital signs, lab tests, carbon monoxide diffusing capacity, oxygen saturation, pulmonary function tests, ECGs, physical exams and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid inhalation solution | Experimental | 3mL of 0.03% Hyaluronic Acid inhalation solution BID for 28 days |
|
| Placebo Inhalation Solution | Placebo Comparator | 3mL matching placebo inhalation solution BID for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid Inhalation Solution | Drug | twice a day 3 mL of 0.03% Hyaluronic Acid Inhalation Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of sputum, plasma and urine concentrations of desmosine and isodesmosine | measurement of biomarkers | 28 days |
| Assessment of pulmonary function tests | measurement of pulmonary function | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of St. George Respiratory Questionnaire | measurement of patient abilities | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard M Turino, MD | Mount Sinai St Lukes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospital | Miami | Florida | 33136 | United States | ||
| Pulmonary Health Physicians, PC |
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treatment has blinded labeling
| Placebo Inhalation Solution | Drug | Twice a day 3 ml of placebo inhalation solution |
|
| Fayetteville |
| New York |
| 13066 |
| United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas Health Science Center | Tyler | Texas | 75708 | United States |
| Medical College of Wisconsin / Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Inspiration Research Limited | Toronto | Ontario | M5T 3A9 | Canada |
| ID | Term |
|---|---|
| D004646 | Emphysema |
| D019896 | alpha 1-Antitrypsin Deficiency |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013352 | Subcutaneous Emphysema |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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