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NCT02008162 Clinical Trial

Bronchoreversibility and Radiologic Morphology of Emphysema

COPD Clinical Trial

Official title:
Response to Bronchodilation With Tiotropium Plus Salbutamol Correlates With Radiologic Morphology of the Lung in COPD of the Emphysematous Phenotype

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02008162
Other study ID # BREPTV-108.7
Secondary ID
Status Recruiting
Phase N/A
First received December 6, 2013
Last updated December 6, 2013
Start date November 2009

Study information
Verified date December 2013
Source University of Rome Tor Vergata
Contact n/a
Is FDA regulated No
Health authority Italy: Comitato Etico, Fondazione Policlinico Tor Vergata
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Bronchodilators
Administration of both albuterol and tiotropium bromide after a 48h period of washout from all bronchodilators, followed by spirometry and plethysmography

Locations
Country Name City State
Italy Fondazione Policlinico Tor Vergata Rome

Sponsors (1)
Lead Sponsor Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary post-bronchodilator FEV1 change Assessed by spirometry carried out before and after administration of bronchodilators 1 h No
Primary post-bronchodilator change in FVC Assessed by spirometry carried out before and after administration of bronchodilators 1h No
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