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This study evaluates the use of RNS60 in the treatment of asthma examining regional improvements in inflammation using PET imaging. All subjects will be treated with both RNS60 and placebo in a crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RNS60 | Experimental | RNS60 4 ml, inhaled twice daily by nebulization for 21 days. |
|
| Normal Saline | Placebo Comparator | Normal Saline 4 ml, inhaled twice daily by nebulization for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNS60 | Drug |
| ||
| Normal Saline |
| Measure | Description | Time Frame |
|---|---|---|
| 18F-FDG uptake rate | Comparison of fluorodeoxyglucose (18F-FDG) uptake rate in subjects before and after inhalation of RNS60 or placebo | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Regional VA and Vdef volume | Comparison of regional ventilation (VA) and ventilation defective areas (Vdef) volume in subjects before and after inhalation of RNS60 or placebo | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2696 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000627108 | RNS60 |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |