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

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplant Infection
• Intervention / Treatment: Drug: Inhaled beclomethasone; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Ramsey Hachem, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: January 26, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Chronic lung allograft dysfunction; Community-acquired respiratory viral infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Virus Diseases; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone
• Other Study ID Numbers: WUIBCARV1-201404080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No