Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

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.

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Key information

Conditions

Alpha-1 Antitrypsin Deficiency Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Emphysema Genetic Diseases, Inborn Liver Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Subcutaneous Emphysema alpha 1-Antitrypsin Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

collection of sputum

Other

Primary outcomes

composition of microbioma in sputa

Time frame: 2 years

Secondary outcomes

correlation with clinical and physiological parameters

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Fondazione Salvatore Maugeri

Other

Collaborators

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Fondazione IRCCS Policlinico San Matteo di Pavia
Grifols Biologicals, LLC

Registry information

Acronym: AATD

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Sep 11, 2015
Registry last updated: Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed