Bronchoreversibility and Radiologic Morphology of Emphysema

December 6, 2013 updated by: Eugenio Pompeo, University of Rome Tor Vergata

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00133
        • Recruiting
        • Fondazione Policlinico Tor Vergata
        • Contact:
        • Principal Investigator:
          • Eugenio Pompeo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Bronchodilators
Administration of both albuterol and tiotropium bromide after a 48h period of washout from all bronchodilators, followed by spirometry and plethysmography
Other Names:
  • Tiotropium bromide
  • Albuterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-bronchodilator FEV1 change
Time Frame: 1 h
Assessed by spirometry carried out before and after administration of bronchodilators
1 h
post-bronchodilator change in FVC
Time Frame: 1h
Assessed by spirometry carried out before and after administration of bronchodilators
1h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Investigators

  • Principal Investigator: Eugenio Pompeo, MD, Tor Vergata University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 6, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BREPTV-108.7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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