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

Primary Purpose

Lung Transplant Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Inhaled beclomethasone
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Transplant Infection focused on measuring Chronic lung allograft dysfunction, Community-acquired respiratory viral infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaled beclomethasone

Placebo

Arm Description

Inhaled beclomethasone 320 mcg twice daily for 180 days.

Inhaled placebo twice daily for 180 days.

Outcomes

Primary Outcome Measures

Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction
Death

Secondary Outcome Measures

Acute Rejection
Lymphocytic Bronchiolitis
Donor-specific Antibodies
Chronic Lung Allograft Dysfunction

Full Information

First Posted
January 26, 2015
Last Updated
February 8, 2022
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02351180
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant Infection
Keywords
Chronic lung allograft dysfunction, Community-acquired respiratory viral infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled beclomethasone
Arm Type
Experimental
Arm Description
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inhaled placebo twice daily for 180 days.
Intervention Type
Drug
Intervention Name(s)
Inhaled beclomethasone
Intervention Description
Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will serve as a control treatment
Primary Outcome Measure Information:
Title
Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction
Time Frame
180 days
Title
Death
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Acute Rejection
Time Frame
180 days
Title
Lymphocytic Bronchiolitis
Time Frame
180 days
Title
Donor-specific Antibodies
Time Frame
180 days
Title
Chronic Lung Allograft Dysfunction
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramsey Hachem, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD

Learn more about this trial

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

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