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

Lung Transplant Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351180
• Other study ID #: WUIBCARV1-201404080
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: January 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Lung Transplant Infection
• Virus Diseases

Intervention

Drug:
• Inhaled beclomethasone
Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
• Placebo
Placebo will serve as a control treatment

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction		180 days
Primary	Death		180 days
Secondary	Acute Rejection		180 days
Secondary	Lymphocytic Bronchiolitis		180 days
Secondary	Donor-specific Antibodies		180 days
Secondary	Chronic Lung Allograft Dysfunction		180 days