Forced Oscillatory Technique for Bronchiolitis Obliterans Syndrome After Allogeneic Bone Marrow Transplantation

NCT07730931 · tracked via the Priya Life Science Israel tracker

Sponsor

Hadassah Medical Organization

Phase

Not applicable

Started

2021-08-19

Last updated

2026-07-28

Condition(s) studied

Bronchiolitis Obliterable Syndrome

Investigational drug(s) / intervention(s)

FOT - Forced Oscillation Technique

FOT - Forced Oscillation Technique: Forced Oscillation Technique (FOT) performed in addition to standard pulmonary function testing for the assessment of bronchiolitis obliterans syndrome after allogeneic hematopoietic stem cell transplantation

Study summary

Bronchiolitis obliterans syndrome (BOS) is a severe pulmonary complication following allogeneic hematopoietic stem cell transplantation (HSCT). This prospective study evaluates the usefulness of the Forced Oscillation Technique (FOT) for the diagnosis, early detection, monitoring, and assessment of treatment response in patients undergoing allogeneic HSCT. FOT results will be compared with standard pulmonary function tests (spirometry, lung volumes, and DLCO).

Eligibility

Sex

ALL

Min age

6 Months

Max age

—

Healthy volunteers

Inclusion Criteria: 1. All patients age 6 months and above, undergoing allogeneic HSCT, referred for pulmonary function test evaluation at the Hadassah Ein Kerem Institute of Pulmonary Medicine . 2. Ability to provide informed consent for performing FOT and database enrollment by patient or legal guardians. Exclusion Criteria: 1\. Inability or unwillingness to perform FOT

Primary outcome measure(s)

Diagnostic accuracy of FOT for early detection of Bronchiolitis obliterans syndrome (BOS) — From allogeneic HSCT to 3 years after transplantation
Diagnostic accuracy of FOT for early detection of BOS, assessed by sensitivity, specificity, and comparison with standard pulmonary function tests.
Correlation between standard pulmonary function tests and Forced Oscillatory Technique (FOT) in patients with or without BOS following allo HSCT in children and adults — From allogeneic HSCT to 3 years after transplantation
Correlation between standard pulmonary function tests parameters (spirometry, static lung volumes and DLCO) and Forced Oscillatory Technique (FOT) measurements in patients with or without BOS following allogeneic HSCT in children and adults
Prevalence of small airway disease detected by FOT — From allogeneic HSCT to 3 years after transplantation
Prevalence of small airway disease detected by FOT following allogeneic HSCT, specifically in pediatric and adult patients with normal spirometry
FOT measurements during follow-up and response to medical treatment — From allogeneic HSCT to 3 years after transplantation
4\. Changes in FOT measurements during follow up and response to medical treatment in these patients

Trial sites (1)

Facility	City	Region	Status
Hadassah MO, Jerusalem, 9574869, Jerusalem,	Jerusalem	Israel	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07730931 on ClinicalTrials.gov ↗ ← All trials in Israel