Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

Alpha-1 Antitrypsin Deficiency Clinical Trial

— AATD  

Official title:

Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547532
• Other study ID #: Fsalvatoremaugeri
• Status: Completed
• Start date: September 2015
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Alpha-1 Antitrypsin Deficiency

Intervention

Other:
• collection of sputum

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri	Azienda Ospedaliera Spedali Civili di Brescia, Grifols Biologicals Inc., IRCCS Policlinico S. Matteo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composition of microbioma in sputa		2 years
Secondary	correlation with clinical and physiological parameters		2 years