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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02351180
Recruitment Status : Active, not recruiting
First Posted : January 30, 2015
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Lung Transplant Infection Drug: Inhaled beclomethasone Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Placebo Controlled Trial of Inhaled Beclomethasone After Community-acquired Respiratory Viral Infection in Lung Transplant Recipients
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Freedom from new or progressive chronic lung allograft dysfunction [ Time Frame: 180 days ]
  2. Death [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Respiratory virus symptom score [ Time Frame: 7 days ]
  2. Acute rejection [ Time Frame: 180 days ]
  3. Lymphocytic bronchiolitis [ Time Frame: 180 days ]
  4. Donor-specific antibodies [ Time Frame: 180 days ]
  5. Chronic lung allograft dysfunction [ Time Frame: 365 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351180


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Ramsey Hachem, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02351180    
Other Study ID Numbers: WUIBCARV1-201404080
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

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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
Keywords provided by Washington University School of Medicine:
Chronic lung allograft dysfunction
Community-acquired respiratory viral infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Virus Diseases
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents