Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

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 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., , 

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