Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency (AATD)

Fondazione Salvatore Maugeri

Status: Completed

Conditions: Alpha-1 Antitrypsin Deficiency

Treatments: Other: collection of sputum

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02547532

Fsalvatoremaugeri

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

100 participants in 5 patient groups

usual COPD

Description:

Patients meeting the diagnostic criteria for COPD and without AATD

Treatment:

Other: collection of sputum

normal smokers

Description:

subjects with a history of smoking, without symptoms, without AATD and with normal lung function

Treatment:

Other: collection of sputum

normal non smokers

Description:

subjects without a history of smoking, without symptoms, without AATD and with normal lung function

Treatment:

Other: collection of sputum

AATD not treated

Description:

patients with COPD, with AATD and not on augmentation therapy for AATD

Treatment:

Other: collection of sputum

AATD treated

Description:

patients with COPD, with AATD on augmentation therapy for AATD

Treatment:

Other: collection of sputum