Bronchoreversibility and Radiologic Morphology of Emphysema

Overview

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.

Full Title of Study: “Response to Bronchodilation With Tiotropium Plus Salbutamol Correlates With Radiologic Morphology of the Lung in COPD of the Emphysematous Phenotype”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2013

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Rome Tor Vergata
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eugenio Pompeo, Associate Professor – University of Rome Tor Vergata
  • Overall Official(s)
    • Eugenio Pompeo, MD, Principal Investigator, Tor Vergata University

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