Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

Completed

• Conditions: Alpha-1 Antitrypsin Deficiency
• Interventions: Other: collection of sputum

• Registration Number: NCT02547532
• Lead Sponsor: Fondazione Salvatore Maugeri

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

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal smokers	collection of sputum	subjects with a history of smoking, without symptoms, without AATD and with normal lung function
AATD treated	collection of sputum	patients with COPD, with AATD on augmentation therapy for AATD
usual COPD	collection of sputum	Patients meeting the diagnostic criteria for COPD and without AATD
normal non smokers	collection of sputum	subjects without a history of smoking, without symptoms, without AATD and with normal lung function
AATD not treated	collection of sputum	patients with COPD, with AATD and not on augmentation therapy for AATD

Primary Outcome Measures

Name	Time	Method
composition of microbioma in sputa	2 years

Secondary Outcome Measures

Name	Time	Method
correlation with clinical and physiological parameters	2 years