Bronchodilator Responsiveness in Obliterative Bronchiolitis

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Treatments: Albuterol; Bronchodilator Agents; Tiotropium Bromide

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