Microbioma in Sputa From COPD With Alpha-1 Antitrypsin De... | NCT02547532

Studies
Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

NCT02547532

Sponsor

Fondazione Salvatore Maugeri

Status

Completed

Last Update Posted

Aug 1, 2018Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Alpha-1 Antitrypsin Deficiency

Interventions

collection of sputum

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Sep 9, 2015

First Submission Date that Met QC Criteria

Sep 9, 2015

First Posted Date

Sep 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2018

Last Update Posted Date

Aug 1, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bruno Balbi, Head, Pulmonary Rehabilitation Department, Fondazione Salvatore MaugeriPrincipal Investigator

Lead Sponsor

Fondazione Salvatore MaugeriOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
collection of sputum	Other		AATD not treated AATD treated normal non smokers normal smokers usual COPD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
composition of microbioma in sputa		2 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pantaleo Giannuzzi, M.D.	Fondazione Salvatore Maugeri	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019896	alpha 1-Antitrypsin Deficiency
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided