Bronchoreversibility and Radiologic Morphology of Emphysema

NCT ID: NCT02008162

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Brief Summary

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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

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Conditions

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Emphysema COPD

Keywords

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Emphysema, COPD, bronchoreversibility, ventilatory obstruction, lung volume reduction surgery, LVRS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bronchodilators

Intervention Type DRUG

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

Interventions

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Bronchodilators

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

Intervention Type DRUG

Other Intervention Names

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Albuterol Tiotropium bromide

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Eugenio Pompeo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugenio Pompeo, MD

Role: PRINCIPAL_INVESTIGATOR

Tor Vergata University

Locations

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Fondazione Policlinico Tor Vergata

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Eugenio Pompeo, MD

Role: primary

Other Identifiers

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BREPTV-108.7

Identifier Type: -

Identifier Source: org_study_id