Bronchiolitis Obliterable SyndromeNCT07730931
Forced Oscillatory Technique for Bronchiolitis Obliterans Syndrome After Allogeneic Bone Marrow Transplantation
A study testing FOT - Forced Oscillation Technique in people with Bronchiolitis Obliterable Syndrome, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Bronchiolitis Obliterable Syndrome
- What is being tested?
- FOT - Forced Oscillation Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Aug 2021to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Inability or unwillingness to perform FOT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah MO, Jerusalem, 9574869, Jerusalem,
Jerusalem
Rotem Kuint, MD, +972532207609, kuint@hadassah.org.il
About this study
Official title: Forced Oscillatory Technique for the Diagnosis, Monitoring, and Assessment of Treatment Response in Bronchiolitis Obliterans Syndrome Following 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).
Read the detailed description
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
- Conditions
- Bronchiolitis Obliterable Syndrome
- Being tested
- FOT - Forced Oscillation Technique
- Keywords
- FOT, BOS, Bronchiolitis Obliterable Syndrome, Forced Oscillation Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOT - Forced Oscillation TechniqueDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| FOT Assessment | Experimental | Not described Receives: Diagnostic Test: FOT - Forced Oscillation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of FOT for early detection of Bronchiolitis obliterans syndrome (BOS)
Diagnostic accuracy of FOT for early detection of BOS, assessed by sensitivity, specificity, and comparison with standard pulmonary function tests.
Measured: From allogeneic HSCT to 3 years after transplantation
Correlation between standard pulmonary function tests and Forced Oscillatory Technique (FOT) in patients with or without BOS following allo HSCT in children and adults
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
Measured: From allogeneic HSCT to 3 years after transplantation
Prevalence of small airway disease detected by FOT
Prevalence of small airway disease detected by FOT following allogeneic HSCT, specifically in pediatric and adult patients with normal spirometry
Measured: From allogeneic HSCT to 3 years after transplantation
FOT measurements during follow-up and response to medical treatment
- Changes in FOT measurements during follow up and response to medical treatment in these patients
Measured: From allogeneic HSCT to 3 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start19 Aug 2021
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis Obliterable SyndromeStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rotem Kuint, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730931
- Sponsor's protocol ID
- 0401-21 HMO
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forced Oscillatory Technique for the Diagnosis, Monitoring, and Assessment of Treatment Response in Bronchiolitis Obliterans Syndrome Following Allogeneic Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT07730931
- Acronym / sponsor ID
- 0401-21 HMO
- Conditions
- Bronchiolitis Obliterable Syndrome
- Keywords
- FOT, BOS, Bronchiolitis Obliterable Syndrome, Forced Oscillation Technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOT Assessment | Experimental | Diagnostic Test: FOT - Forced Oscillation Technique |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Inability or unwillingness to perform FOT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOT - Forced Oscillation TechniqueForced Oscillation Technique (FOT) performed in addition to standard pulmonary function testing for the assessment of bronchiolitis obliterans syndrome after allogeneic hematopoietic stem cell transplantation | Diagnostic test | FOT Assessment |
Primary outcome
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.
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
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
FOT measurements during follow-up and response to medical treatment
Time frame: From allogeneic HSCT to 3 years after transplantation
4. Changes in FOT measurements during follow up and response to medical treatment in these patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Bronchiolitis Obliterable Syndrome
RecruitingObservational study
Longitudinal Pulmonary Chronic Graft-versus-host-disease (GvHD) Assessment in Hematopoietic Stem Cell Transplantation (HSCT) Patients
Bronchiolitis Obliterable Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOT - Forced Oscillation Technique in people with Bronchiolitis Obliterable Syndrome, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rottem Kuint, MD (+972532207609, KUINT@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of FOT for early detection of Bronchiolitis obliterans syndrome (BOS) (time frame: From allogeneic HSCT to 3 years after transplantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.