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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Transplant Infection

Intervention / Treatment
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* Drug: Inhaled beclomethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled beclomethasone<br>Inhaled beclomethasone 320 mcg twice daily for 180 days. | Drug: Inhaled beclomethasone<br>* Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection<br>|
| Placebo Comparator: Placebo<br>Inhaled placebo twice daily for 180 days. | Drug: Placebo<br>* Placebo will serve as a control treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction |  | 180 days | 
| Death |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Rejection |  | 180 days | 
| Lymphocytic Bronchiolitis |  | 180 days | 
| Donor-specific Antibodies |  | 180 days | 
| Chronic Lung Allograft Dysfunction |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic lung allograft dysfunction, Community-acquired respiratory viral infection