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

NCT ID: NCT02351180

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2021-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Inhaled beclomethasone

Inhaled beclomethasone 320 mcg twice daily for 180 days.

Group Type: EXPERIMENTAL

Inhaled beclomethasone

Intervention Type: DRUG

Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection

Placebo

Inhaled placebo twice daily for 180 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will serve as a control treatment

Interventions

Inhaled beclomethasone

Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection

Intervention Type: DRUG

Placebo

Placebo will serve as a control treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult (≥ 18 years old)
• Single, bilateral, or heart-lung transplant recipient
• Confirmed infection with a community-acquired respiratory virus including: adenovirus, coronavirus, influenza A or B, respiratory syncytial virus (RSV), parainfluenza virus (PiV), human metapneumovirus (hMPV), and rhinovirus
• At least 6 months post-transplant, with completion of 6 month bronchoscopy if indicated
• Able and willing to give written informed consent and comply with study procedures (e.g. testing, treatment)

Exclusion Criteria

• BOS Stage 3
• Requirement for mechanical ventilation at study entry
• Use of inhaled steroids at the time of CARV infection
• Any condition that in the investigator's opinion would preclude the patient's participation in a clinical trial
• Lack of available spirometric data to establish a baseline forced expiratory volume in 1 second and/or forced vital capacity
• Pregnancy
• Current participation in another interventional clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramsey Hachem, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

WUIBCARV1-201404080

Identifier Type: -

Identifier Source: org_study_id