Phase 2
N=16
Inhaled Beclomethasone After Community-Acquired Respiratory Viral Infection in Lung Transplant Recipients
Lung Transplant Infection
Bottom Line
View on ClinicalTrials.gov: NCT02351180 ↗Enrolled (actual)
16
Serious AEs
53.3%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction — 2; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Inhaled beclomethasone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction |
2; 4 | — |
| PRIMARY Death |
0; 0 | — |
| SECONDARY Acute Rejection |
1; 0 | — |
| SECONDARY Lymphocytic Bronchiolitis |
0; 1 | — |
| SECONDARY Donor-specific Antibodies |
0; 0 | — |
| SECONDARY Chronic Lung Allograft Dysfunction |
2; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02351180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.