Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02547532

Acronym

AATD

Enrollment

100

Registered

2015-09-11

Start date

2015-09-30

Completion date

2018-04-30

Last updated

2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alpha-1 Antitrypsin Deficiency

Keywords

COPD, alpha-1 antitrypsin deficiency, microbioma

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.

Interventions

OTHERcollection of sputum

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
composition of microbioma in sputa	2 years

Secondary

Measure	Time frame
correlation with clinical and physiological parameters	2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026