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

NCT02351180 | Completed Phase 1 Results FDA Drug

• 1 other identifier: WUIBCARV1-201404080
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant Infection

Keywords

Chronic lung allograft dysfunction; Community-acquired respiratory viral infection

Outcome Measures

Primary Outcomes (2)

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

  180 days

• Death

  180 days

Secondary Outcomes (4)

• Acute Rejection

  180 days

• Lymphocytic Bronchiolitis

  180 days

• Donor-specific Antibodies

  180 days

• Chronic Lung Allograft Dysfunction

  180 days

Study Arms (2)

Inhaled beclomethasone

EXPERIMENTAL

Inhaled beclomethasone 320 mcg twice daily for 180 days.

Drug: Inhaled beclomethasone

Placebo

PLACEBO COMPARATOR

Inhaled placebo twice daily for 180 days.

Drug: Placebo

Interventions

Inhaled beclomethasone DRUG

Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection

Inhaled beclomethasone

Placebo DRUG

Placebo will serve as a control treatment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Results Point of Contact

• Title: Ramsey Hachem, MD
• Organization: Washington University in St. Louis

rhachem@wustl.edu

3144548766

Study Officials

• Ramsey Hachem, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: January 30, 2015
• Study Start: February 1, 2017
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: March 3, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)