Phase 4
N=17
Bronchodilator Responsiveness in Obliterative Bronchiolitis
Obliterative Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT01112241 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators — 14; 7 per cent positive change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- albuterol plus tiotropium (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators |
14; 7 | — |
| PRIMARY Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators |
0.26; 0.12 | — |
| PRIMARY Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators |
24; 2 | — |
| PRIMARY Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators |
0.65; 0.07 | — |
| PRIMARY Per Cent Change of Instantaneous Maximal Forced Expiratory Flow (V'Max) After Bronchodilators |
66; 14 | — |
| PRIMARY Per Cent Change of Partial Forced Expiratory Flow (V'Part) After Bronchodilators |
59; 17 | — |
| PRIMARY Per Cent Change of Residual Volume (RV) After Bronchodilators |
19; 0 | — |
| PRIMARY Absolute Change of Residual Volume (RV) After Bronchodilators |
0.65; 0.00 | — |
| PRIMARY Per Cent Change of Functional Residual Capacity (FRC) After Bronchodilators |
16; 2 | — |
| PRIMARY Absolute Change of Functional Residual Capacity (FRC) After Bronchodilators |
0.78; 0.07 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Obliterative bronchiolitis (OB) following allogeneic HSCT
- FEV1 to slow inspiratory vital capacity (VC) ratio (FEV1/VC) 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
Data sourced from ClinicalTrials.gov (NCT01112241). 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.