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

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.

Study Overview

• Status: Completed
• Conditions: Alpha-1 Antitrypsin Deficiency
• Intervention / Treatment: Other: collection of sputum

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Normal volunterrs Patients with COPD without AATD Patients with COPD and with AATD

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
composition of microbioma in sputa	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
correlation with clinical and physiological parameters	2 years

Collaborators and Investigators

• Sponsor: Fondazione Salvatore Maugeri
• Collaborators: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia; Grifols Biologicals, LLC; IRCCS Policlinico S. Matteo
• Investigators: Study Director: Pantaleo Giannuzzi, M.D., Fondazione Salvatore Maugeri

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: COPD; microbioma; alpha-1 antitrypsin deficiency
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Liver Diseases; Genetic Diseases, Inborn; Subcutaneous Emphysema; Emphysema; Alpha 1-Antitrypsin Deficiency
• Other Study ID Numbers: Fsalvatoremaugeri