An interventional study of FOT - Forced Oscillation Technique in Bronchiolitis Obliterable Syndrome, sponsored by Hadassah Medical Organization. Recruiting at 1 site in Israel. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Diagnostic
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).
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
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 195 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Hadassah Medical Organization is the lead sponsor of 675 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
1. Inability or unwillingness to perform FOT
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: 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
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.
Time frame: 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
Time frame: 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
Time frame: From allogeneic HSCT to 3 years after transplantation
FOT measurements during follow-up and response to medical treatment
4\. Changes in FOT measurements during follow up and response to medical treatment in these patients
Time frame: From allogeneic HSCT to 3 years after transplantation
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2021 (actual). Primary completion is estimated for Dec 2028, 88 months after the start.
Of 54 non-industry interventional studies with no phase under Bronchiolitis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 88 months is above that.
Counting every sponsor, half of 57 studies reached it within 22 months; a quarter within 11 and three quarters within 35.
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