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To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.
To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0. Treating physicians will follow standard of care for patients and monitor pulmonary function, fractional exhaled nitric oxide and quality of life of the patients.
Patient safety will be monitored by assessing changes in these parameters, as well as changes in standard of care measurements (e.g., laboratory values and x-ray images).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARINA-1 | Experimental | Ascorbic acid (ARINA-1) (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic Acid | Drug | ARINA-1 (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in FEV1 | Each individual's changes in pulmonary function will be assessed using the linear slope of FEV1 change from enrollment to the end of the treatment period. | Baseline, 1 month, 3 months, 6 months, 12 months |
| Changes in FENO | Each individual's changes in FENO will be assessed using the change in mean baseline FENO measurements to the mean measurements post-ARINA-1 use. | Baseline |
| Changes in Quality of Life | Patient-reported quality of life measures assessed pre- and post-ARINA-1 will be compared for each participant. | Baseline, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar Mohamedaly, MD | Duke Health | Principal Investigator |
| Lorenzo Zaffiri, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |