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Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

Descriptive Information
Brief Title † Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
Official Title † Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
Brief Summary In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. These quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.
Detailed Description
Study Phase N/A
Study Type † Observational
Study Design † Observational Model: Cohort, Time Perspective: Cross-Sectional
Primary Outcome Measure † composition of microbioma in sputa
Secondary Outcome Measure † correlation with clinical and physiological parameters
Condition † Alpha-1 Antitrypsin Deficiency
Intervention † Othercollection of sputum
Study Arms / Comparison Groups usual COPD Patients meeting the diagnostic criteria for COPD and without AATD normal smokers subjects with a history of smoking, without symptoms, without AATD and with normal lung function normal non smokers subjects without a history of smoking, without symptoms, without AATD and with normal lung function AATD not treated patients with COPD, with AATD and not on augmentation therapy for AATD AATD treated patients with COPD, with AATD on augmentation therapy for AATD
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Other
Estimated Enrollment † 100
Start Date † September 2015
Completion Date October 2017
Primary Completion Date March 2017
Eligibility Criteria † Inclusion Criteria: - diagnosis of COPD and a clinical stable condition, i.e. at least three months from the last AECOPD and/or antibiotic treatment. For patients with AATD this condition will be diagnosed by laboratory tests showing low levels of AAT and genotyping of AATD-related genes. . Exclusion Criteria: - The presence of important co-morbidities (diabetes, systemic or organ infections, immunodeficiency, tumors, moderate-severe heart failure) will be considered as exclusion criteria.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts †† Bruno Balbi, M.D., Ph.D., +39-0322-884711, bruno.balbi@fsm.it
Location Countries †
Administrative Information
NCT ID † NCT02547532
Organization ID Fsalvatoremaugeri
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Fondazione Salvatore Maugeri
Collaborators †† IRCCS Policlinico S. Matteo
Investigators † Study Director: Pantaleo Giannuzzi, M.D., Fondazione Salvatore Maugeri
Information Provided By
Verification Date September 2015
First Received Date † September 9, 2015
Last Updated Date September 9, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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