NCT03226431

Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0

Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0 at Duke University to Improve FEV1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.

Detailed description

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).

Conditions

• Lung Transplant

Interventions

Type	Name	Description
DRUG	Ascorbic Acid	ARINA-1 (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer

Timeline

• Start date: 2017-12-11
• Primary completion: 2019-06-25
• Completion: 2019-06-25
• First posted: 2017-07-21
• Last updated: 2019-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study