Closing Volume Interpretation and Bronchodilators Effect

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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 a small evidence

• Data about real effect of bronchodilators on SAW (eg Tiotropium and Indacaterol) has never been studied

• Only an acute bronchodilators effect, after one hour of drugs inhalation, will be evaluated

• The time frame of study evaluations per patient will be of three hours: one hour for basal test; one hour rest after drug administration; one hour for post bronchodilators test

• All enrolled subjects will be outpatients and will be evaluated after 24 hours of inhalatory drugs washout

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Milan
• Collaborator: Fondazione Salvatore Maugeri
• Treatments: Bromides; Bronchodilator Agents; Maleic acid; Tiotropium Bromide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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