Clinical trial NCT02351180: Inhaled Beclomethasone After Community-Acquired Respiratory Viral Infection in Lung Transplant Recipients
Official title: A Randomized Placebo Controlled Trial of Inhaled Beclomethasone After Community-acquired Respiratory Viral Infection in Lung Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Transplant Infection
Keywords: Chronic lung allograft dysfunction
Community-acquired respiratory viral infection
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction
timeFrame: 180 days
measure: Death
timeFrame: 180 days
Secondary outcomes:
measure: Acute Rejection
timeFrame: 180 days
measure: Lymphocytic Bronchiolitis
timeFrame: 180 days
measure: Donor-specific Antibodies
timeFrame: 180 days
measure: Chronic Lung Allograft Dysfunction
timeFrame: 180 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ramsey Hachem, MD
role: PRINCIPAL_INVESTIGATOR
References: