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Trial record 1 of 80 for:    ALPHA-1-ANTITRYPSIN DEFICIENCY
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Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency (AATD)

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ClinicalTrials.gov Identifier: NCT02547532
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : August 1, 2018
Sponsor:
Collaborators:
IRCCS Policlinico S. Matteo
Azienda Ospedaliera Spedali Civili di Brescia
Grifols Biologicals Inc.
Information provided by (Responsible Party):
Bruno Balbi, Fondazione Salvatore Maugeri

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.

Condition or disease Intervention/treatment
Alpha-1 Antitrypsin Deficiency Other: collection of sputum

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
Actual Study Start Date : September 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018


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



Primary Outcome Measures :
  1. composition of microbioma in sputa [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. correlation with clinical and physiological parameters [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Normal volunterrs Patients with COPD without AATD Patients with COPD and with AATD
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547532


Sponsors and Collaborators
Fondazione Salvatore Maugeri
IRCCS Policlinico S. Matteo
Azienda Ospedaliera Spedali Civili di Brescia
Grifols Biologicals Inc.
Investigators
Study Director: Pantaleo Giannuzzi, M.D. Fondazione Salvatore Maugeri

Responsible Party: Bruno Balbi, Head, Pulmonary Rehabilitation Department, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT02547532     History of Changes
Other Study ID Numbers: Fsalvatoremaugeri
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Keywords provided by Bruno Balbi, Fondazione Salvatore Maugeri:
COPD
alpha-1 antitrypsin deficiency
microbioma

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action