Response to Bronchodilation With Tiotropium Plus Salbutamol Correlates With Radiologic Morphology of the Lung in COPD of the Emphysematous Phenotype
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- post-bronchodilator FEV1 change
Study Overview
Brief Summary
To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe emphysema and analyze relationships between bronchoreversibility response and semiquantitative computed-tomography based emphysema severity measures.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Radiologic evidence of severe heterogeneous emphysema
- •GOLD COPD class III-IV
- •No other significant pulmonary comorbidity
- •Quit smoking since at least 4 months
Exclusion Criteria
- Not provided
Arms & Interventions
Bronchodilators
Patients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery.
Bronchodilators employed for the study include albuterol 200µg and tiotropium bromide 18 µg administered by puffs following a first spirometry and plethysmography performed after a washout period of 48h from all bronchodilators and subsequently repeated within 30 min after bronchodilators administration.
Intervention: Bronchodilators (Drug)
Outcomes
Primary Outcomes
post-bronchodilator FEV1 change
Time Frame: 1 h
Assessed by spirometry carried out before and after administration of bronchodilators
post-bronchodilator change in FVC
Time Frame: 1h
Assessed by spirometry carried out before and after administration of bronchodilators
Secondary Outcomes
No secondary outcomes reported
Investigators
Eugenio Pompeo
Associate Professor
University of Rome Tor Vergata