Bronchoreversibility and Radiologic Morphology of Emphysema

• Conditions: Emphysema; COPD
• Interventions: Drug: Bronchodilators

• Registration Number: NCT02008162
• Lead Sponsor: University of Rome Tor Vergata

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-06
• Last Update Submitted: 2013-12-06
• Study First Posted: 2013-12-11
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bronchodilators	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.

Primary Outcome Measures

Name	Time	Method
post-bronchodilator FEV1 change	1 h	Assessed by spirometry carried out before and after administration of bronchodilators
post-bronchodilator change in FVC	1h	Assessed by spirometry carried out before and after administration of bronchodilators

Trial Locations

Locations (1)

Fondazione Policlinico Tor Vergata; 🇮🇹 Rome, Italy