Obliterative Bronchiolitis Clinical Trial
Official title:
Acute Bronchodilator Responsiveness in Obliterative Bronchiolitis (OB) Following Hematopoietic Stem Cell Transplantation
This study has been designed to provide a substantial evidence of acute bronchodilator responsiveness to two sequentially inhaled drugs, a beta2-agonist (i.e., albuterol) and an anticholinergic (i.e., tiotropium bromide), in a group of patients who developed obliterative bronchiolitis after hematopoietic stem cell transplantation.
Obliterative bronchiolitis is a life-threatening non-infectious pulmonary complication of
allogeneic hematopoietic stem cell transplantation (HSCT). It is characterized by the
development of an obstructive abnormality which has been considered to be insensitive to
bronchodilator treatments. However, this knowledge stems from measurements of forced
expiratory volume in 1 s (FEV1) which is relatively insensitive to changes in small airway
caliber. Moreover, it is known from studies in chronic obstructive pulmonary disease that
symptoms improve after bronchodilator treatment even when FEV1 is minimally increased and
correlate with the reduction of lung hyperinflation, which is the major consequence of
severe expiratory airflow limitation. Therefore, measurements of airway caliber by
parameters not affected by volume history and absolute lung volumes are preferable for
assessing the effect of bronchodilator interventions.
In the current study, the bronchodilators responsiveness will be assessed by using not only
spirometry but also measurements of absolute lung volumes and the forced expiratory flow of
a partial maneuver (V'part) started from submaximal lung inflation, thus free of volume
history effects.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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||
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|
N/A |