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Bronchodilator Responsiveness in Obliterative Bronchiolitis

Information source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obliterative Bronchiolitis

Intervention: albuterol plus tiotropium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Official(s) and/or principal investigator(s):
Giovanni Barisione, MD, Principal Investigator, Affiliation: Unit of Preventive and Occupational Medicine, University Hospital San Martino, Genoa, Italy

Summary

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.

Clinical Details

Official title: Acute Bronchodilator Responsiveness in Obliterative Bronchiolitis (OB) Following Hematopoietic Stem Cell Transplantation

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome:

Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators

Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators

Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators

Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators

Per Cent Change of Instantaneous Maximal Forced Expiratory Flow (V'Max) After Bronchodilators

Per Cent Change of Partial Forced Expiratory Flow (V'Part) After Bronchodilators

Per Cent Change of Residual Volume (RV) After Bronchodilators

Absolute Change of Residual Volume (RV) After Bronchodilators

Per Cent Change of Functional Residual Capacity (FRC) After Bronchodilators

Absolute Change of Functional Residual Capacity (FRC) After Bronchodilators

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Obliterative bronchiolitis (OB) following allogeneic HSCT

- FEV1 to slow inspiratory vital capacity (VC) ratio (FEV1/VC)<5th percentile

- FEV1 <75% predicted or absolute FEV1 fall >10% of pre-HSCT value

- evidence of OB by computed tomography scanning

- negative microbiological yields in bronchoalveolar lavage fluid

- chronic graft-versus-host disease score >0

- negative history for bronchial asthma, chronic obstructive pulmonary disease or other

significant respiratory disease. Exclusion Criteria:

- inability to perform lung function maneuvers

- pre-existent chronic lung disease other than OB

Locations and Contacts

Unit of Preventive and Occupational Medicine - Laboratory of Respiratory Pathophysiology, University Hospital San Martino, Genoa 16132, Italy
Additional Information

Related publications:

Pellegrino R, Rodarte JR, Brusasco V. Assessing the reversibility of airway obstruction. Chest. 1998 Dec;114(6):1607-12.

Barisione G, Bacigalupo A, Crimi E, Van Lint MT, Lamparelli T, Brusasco V. Changes in lung volumes and airway responsiveness following haematopoietic stem cell transplantation. Eur Respir J. 2008 Dec;32(6):1576-82. doi: 10.1183/09031936.0139807. Epub 2008 Aug 6.

Starting date: April 2010
Last updated: February 28, 2011

Page last updated: August 20, 2015

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