Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

NCT ID: NCT02547532

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-04-30

Brief Summary

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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

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Conditions

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Alpha-1 Antitrypsin Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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usual COPD

Patients meeting the diagnostic criteria for COPD and without AATD

collection of sputum

Intervention Type OTHER

normal smokers

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

collection of sputum

Intervention Type OTHER

normal non smokers

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

collection of sputum

Intervention Type OTHER

AATD not treated

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

collection of sputum

Intervention Type OTHER

AATD treated

patients with COPD, with AATD on augmentation therapy for AATD

collection of sputum

Intervention Type OTHER

Interventions

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collection of sputum

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role collaborator

Grifols Biologicals, LLC

INDUSTRY

Sponsor Role collaborator

Fondazione Salvatore Maugeri

OTHER

Sponsor Role lead

Responsible Party

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Bruno Balbi

Head, Pulmonary Rehabilitation Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pantaleo Giannuzzi, M.D.

Role: STUDY_DIRECTOR

Fondazione Salvatore Maugeri

Other Identifiers

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Fsalvatoremaugeri

Identifier Type: -

Identifier Source: org_study_id

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