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

Phase 1

Completed

• Conditions: Lung Transplant Infection
• Interventions: Drug: Inhaled beclomethasone; Drug: Placebo

• Registration Number: NCT02351180
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-30
• Study Start: 2017-02-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2022-01
• Results First Submitted: 2022-01-18
• Results First Submitted QC: 2022-02-08
• Last Update Submitted: 2022-02-08
• Results First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled beclomethasone	Inhaled beclomethasone	Inhaled beclomethasone 320 mcg twice daily for 180 days.
Placebo	Placebo	Inhaled placebo twice daily for 180 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction	180 days
Death	180 days

Secondary Outcome Measures

Name	Time	Method
Donor-specific Antibodies	180 days
Lymphocytic Bronchiolitis	180 days
Acute Rejection	180 days
Chronic Lung Allograft Dysfunction	180 days

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States