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NCT Number: NCT07730931

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

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).

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Key information

Conditions

Bronchiolitis Obliterable Syndrome

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah MO, Jerusalem, 9574869, Jerusalem,

Jerusalem, Israel

Location status: Recruiting

Location contact

Rotem Kuint, MD

CONTACT

[email protected]

+972532207609

About this study

This prospective study conducted at Hadassah Medical Organization. Patients aged 6 months and older undergoing allogeneic hematopoietic stem cell transplantation who are referred for pulmonary function testing will be enrolled. Participants will undergo standard pulmonary function tests according to routine clinical practice, including spirometry, static lung volumes, and DLCO, together with Forced Oscillation Technique (FOT). Clinical characteristics, transplant characteristics, pulmonary symptoms, graft-versus-host disease status, imaging findings, treatments, and pulmonary function parameters will be collected prospectively. Participants will be followed for up to three years to evaluate the role of FOT in the diagnosis, monitoring, and assessment of bronchiolitis obliterans syndrome and small airway disease following HSCT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 .
  • Ability to provide informed consent for performing FOT and database enrollment by patient or legal guardians.

Exclusion criteria

  • Inability or unwillingness to perform FOT

Treatment and study plan

FOT - Forced Oscillation Technique

Diagnostic Test

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

Primary outcomes

  1. Diagnostic accuracy of FOT for early detection of Bronchiolitis obliterans syndrome (BOS)

    Time frame: 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.

  2. Correlation between standard pulmonary function tests and Forced Oscillatory Technique (FOT) in patients with or without BOS following allo HSCT in children and adults

    Time frame: 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

  3. Prevalence of small airway disease detected by FOT

    Time frame: 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

  4. FOT measurements during follow-up and response to medical treatment

    Time frame: From allogeneic HSCT to 3 years after transplantation

    • Changes in FOT measurements during follow up and response to medical treatment in these patients

Study contacts

Contact information is provided by the study sponsor or research team.

Rottem Kuint, MD

CONTACT

[email protected]

+972532207609

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Forced Oscillatory Technique for the Diagnosis, Monitoring, and Assessment of Treatment Response in Bronchiolitis Obliterans Syndrome Following Allogeneic Bone Marrow Transplantation

Important dates

Study start
2021
Primary completion
2028
Study completion
2030
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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