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Bronchoreversibility and Radiologic Morphology of Emphysema

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ClinicalTrials.gov Identifier: NCT02008162
Recruitment Status : Unknown
Verified December 2013 by Eugenio Pompeo, University of Rome Tor Vergata.
Recruitment status was:  Recruiting
First Posted : December 11, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Eugenio Pompeo, 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.

Condition or disease Intervention/treatment
Emphysema COPD Drug: Bronchodilators

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Response to Bronchodilation With Tiotropium Plus Salbutamol Correlates With Radiologic Morphology of the Lung in COPD of the Emphysematous Phenotype
Study Start Date : November 2009
Actual Primary Completion Date : December 2013


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:
  • Albuterol
  • Tiotropium bromide




Primary Outcome Measures :
  1. post-bronchodilator FEV1 change [ Time Frame: 1 h ]
    Assessed by spirometry carried out before and after administration of bronchodilators

  2. post-bronchodilator change in FVC [ Time Frame: 1h ]
    Assessed by spirometry carried out before and after administration of bronchodilators



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008162


Locations
Italy
Fondazione Policlinico Tor Vergata Recruiting
Rome, Italy, 00133
Contact: Eugenio Pompeo, MD    +393496154524    pompeo@med.uniroma2.it   
Principal Investigator: Eugenio Pompeo, MD         
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
Principal Investigator: Eugenio Pompeo, MD Tor Vergata University

Responsible Party: Eugenio Pompeo, Associate Professor, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT02008162     History of Changes
Other Study ID Numbers: BREPTV-108.7
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by Eugenio Pompeo, University of Rome Tor Vergata:
Emphysema, COPD, bronchoreversibility, ventilatory obstruction, lung volume reduction surgery, LVRS

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Tiotropium Bromide
Albuterol
Bronchodilator Agents
Bromides
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Anticonvulsants