NCT02351180

Inhaled Beclomethasone After Community-Acquired Respiratory Viral Infection in Lung Transplant Recipients

A Randomized Placebo Controlled Trial of Inhaled Beclomethasone After Community-acquired Respiratory Viral Infection in Lung Transplant Recipients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the use of inhaled beclomethasone after a community-acquired respiratory viral infection in a lung transplant recipient decreases the risk of the subsequent development of chronic lung allograft dysfunction.

Detailed description

Community-acquired respiratory viral (CARV) infections after lung transplantation are associated with an increased risk for the development of chronic lung allograft dysfunction (CLAD) after lung transplantation. The exact mechanisms whereby CARV infections increase this risk are unknown. We propose that viral infection results in airway epithelial cell injury and the expression of injury-response genes that provide signals that initiate immunologic and non-immunologic pathways that result in the airway remodeling characteristic of obliterative bronchiolitis, the predominant pathology of CLAD. Systemic and inhaled corticosteroids are frequently used as anti-inflammatory agents to treat the peribronchiolar inflammation seen in viral bronchiolitis. Beneficial effects from corticosteroids have been reported, but this has not been demonstrated in lung transplant recipients. The aim of this single center, randomized, double blind, placebo controlled study is to evaluate the short and long term effects of a 6 month course of inhaled beclomethasone on adult lung transplant recipients with CARV infection.

Conditions

• Lung Transplant Infection

Interventions

Type	Name	Description
DRUG	Inhaled beclomethasone	Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
DRUG	Placebo	Placebo will serve as a control treatment

Timeline

• Start date: 2017-02-01
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2015-01-30
• Last updated: 2022-03-03
• Results posted: 2022-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study