Status:
COMPLETED
Closing Volume Interpretation and Bronchodilators Effect
Lead Sponsor:
University of Milan
Collaborating Sponsors:
Fondazione Salvatore Maugeri
Conditions:
Healthy
COPD
Eligibility:
All Genders
20-85 years
Phase:
PHASE4
Brief Summary
* The gold standard measures to evaluate small airways (SAW) "in vivo" is not well understood * Two tests are today used to measure SAW but real results concordance is not clear * These problems have ...
Detailed Description
Evaluation of small airways both in healthy and Chronic Obstructive Pulmonary Disease (COPD)subjects still today remains a big problem with implications in diagnostic and clinical management. The firs...
Eligibility Criteria
Inclusion
- Signature of informed consent
- Healthy subjects with age from 20 to 80 yars old and never smokers
- COPD diagnosis
- COPD with age from 50 to 85 years old
- History of COPD at least of noe year
- Respiratory stable conditions at least of one month
- Any basal FEV1 expressed in % of predicted value
- FEV1/Forced Vital Capacity (FVC) less than 70%
- COPD with history of former or active smokers with minimum of 20 pack year
Exclusion
- Pregnancy
- FEV1/FVC more than 70%
- Known deficit of alpha 1 antitrypsin
- Subjects submitted to a Lung Volume Reduction Surgery (LVRS)
- Subjects with known positivity to Human Immunodeficiency Virus (HIV)
- Known intolerance to a nasogastric balloon
- Misuse of alcool or drugs
- Absence of compliance in performing respiratory test
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01437748
Start Date
August 1 2011
End Date
September 1 2014
Last Update
October 29 2014
Active Locations (1)
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1
Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS
Milan, Milano, Italy, 20138