N/A
N=26
Respiratory Impedance and Obliterative Bronchiolitis
Hematopoietic Stem Cell Transplantation · Obliterative Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT01255449 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) — 0.07 1/cmH2O*s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- albuterol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) |
0.07 | — |
| SECONDARY Post-HSCT Changes in Lung Tissue Density |
0.03 | — |
Summary
The aim of the present study will be to test the hypothesis that changes in within-breath total respiratory input impedance (Zrs) may provide an early evidence of obliterative bronchiolitis after allogeneic hematopoietic stem cell transplantation (HSCT). Before and after HSCT, Zrs will be measured by a modified forced oscillation technique (FOT) during spontaneous breathing both at baseline and 30 min after albuterol inhalation . Such technique may be particularly sensitive to small changes in lung mechanics observed in the early stages of peripheral airflow obstruction.
Eligibility Criteria
Inclusion Criteria
- consecutive, clinically-stable, outpatients undergoing allogeneic HSCT (sourcing from bone marrow) for hematological malignancies
- values of standard PFTs within normal range before HSCT
- good collaboration during the maneuvers
Exclusion Criteria
- patients showing any spirometric and/or volumetric abnormality before HSCT
- poor collaboration and/or coordination during the maneuvers
- any clinically-significant respiratory disease (bronchial asthma, COPD, cystic fibrosis, etc.) before HSCT
Data sourced from ClinicalTrials.gov (NCT01255449). 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.