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.
Study Type
Observational
Primary Outcome
composition of microbioma in sputa
Secondary Outcome
correlation with clinical and physiological parameters
Condition
Alpha-1 Antitrypsin Deficiency
Intervention
collection of sputum
Study Arms / Comparison Groups
usual COPD
Description: Patients meeting the diagnostic criteria for COPD and without 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
April 2018
Primary Completion Date
April 2018
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
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Pantaleo Giannuzzi, M.D., ,
Administrative Informations
NCT ID
NCT02547532
Organization ID
Fsalvatoremaugeri
Responsible Party
Principal Investigator
Study Sponsor
Fondazione Salvatore Maugeri
Collaborators
IRCCS Policlinico S. Matteo
Study Sponsor
Pantaleo Giannuzzi, M.D., Study Director, Fondazione Salvatore Maugeri
Verification Date
July 2018