Bronchoreversibility and Radiologic Morphology of Emphysema

NCT02008162 | Unknown

• 1 other identifier: BREPTV-108.7
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Emphysema; COPD

Keywords

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

Outcome Measures

Primary Outcomes (2)

• post-bronchodilator FEV1 change

  Assessed by spirometry carried out before and after administration of bronchodilators

  1 h

• post-bronchodilator change in FVC

  Assessed by spirometry carried out before and after administration of bronchodilators

  1h

Study Arms (1)

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

Interventions

Bronchodilators DRUG

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

Also known as: Albuterol, Tiotropium bromide

Bronchodilators

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Radiologic evidence of severe heterogeneous emphysema
• GOLD COPD class III-IV
• No other significant pulmonary comorbidity
• Quit smoking since at least 4 months

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Fondazione Policlinico Tor Vergata

Rome, 00133, Italy

RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Interventions

Bronchodilator Agents; Albuterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Eugenio Pompeo, MD

  Tor Vergata University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: November 1, 2009
• Primary Completion: December 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

IT (1)