Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

NCT02547532 | Completed

• 1 other identifier: Fsalvatoremaugeri
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alpha-1 Antitrypsin Deficiency

Keywords

COPD; alpha-1 antitrypsin deficiency; microbioma

Outcome Measures

Primary Outcomes (1)

• composition of microbioma in sputa

  2 years

Secondary Outcomes (1)

• correlation with clinical and physiological parameters

  2 years

Study Arms (5)

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

Interventions

collection of sputum OTHER

AATD not treated; AATD treated; normal non smokers; normal smokers; usual COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: collaborator
• Grifols Biologicals, LLC: collaborator

MeSH Terms

Conditions

alpha 1-Antitrypsin Deficiency; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes

Study Officials

• Pantaleo Giannuzzi, M.D.

  Fondazione Salvatore Maugeri

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Pulmonary Rehabilitation Department

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07