Role of Innate Immunity in Non-Cystic Fibrosis Bronchiect... | NCT02163642

Studies
Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

NCT02163642

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Unknown status

Last Update Posted

Sep 8, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Bronchiectasis

Interventions

Cyranose® 320

Countries

Spain

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Apr 2018Estimated

Completion Date

Apr 2018Estimated

First Submitted Date

May 19, 2014

First Submission Date that Met QC Criteria

Jun 11, 2014

First Posted Date

Jun 13, 2014Estimated

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

Sep 7, 2016

Last Update Posted Date

Sep 8, 2016Estimated

Name	Class
Sociedad Española de Neumología y Cirugía Torácica	OTHER

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

The purpose of this study is to demonstrate that 1) the secretion of mucins, antimicrobial peptides and Toll-like receptors is altered in certain patients with non-CF bronchiectasis, which makes them more susceptible to be infected by potentially pathogenic bacteria (PPB); and 2) the electronic nose is able to detect patterns of specific Volatile Organic Compounds (VOC) for patients with non-CF bronchiectasis colonized by PPB.

Detailed Description

Prospective, observational study, which will include 50 patients with non-CF bronchiectasis who will be followed for a period of 12 months. A follow up control will be performed every three months to all patients, consisting in medical record, lung function tests, blood and serum collection, sputum analysis and culture, and collection of exhaled air for analysis using an electronic nose. These tests will also be repeated whenever the patient has an exacerbation. At the beginning and end of the study, a high resolution chest CT will be performed.

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

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-CF Bronchiectasis		Cyranose® 320	Device: Cyranose® 320

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyranose® 320	Device	Detection of patterns of specific Volatile Organic Compounds in exhaled air	Non-CF Bronchiectasis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in sputum mucin levels at 12 months	Mucin levels in sputum will be determined with ELISA kits	Baseline and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in sputum mucin levels at 3 months	Mucin levels in sputum will be determined with ELISA kits	Baseline and 3 months
Change from baseline in sputum mucin levels at 6 months

Other Outcomes

Measure	Description	Time Frame
Change from baseline in patterns of specific volatile organic compounds in exhaled air at 3 months	The patterns of specific volatile organic compounds in exhaled air will be determined with the electronic nose device (Cyranose® 320).	Baseline and 3 months
Change from baseline in patterns of specific volatile organic compounds in exhaled air at 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of non- CF bronchiectasis based on at least 1 lobe with bronchial dilatation and compatible clinical symptoms such as cough, sputum production and respiratory infections.
Signed informed consent.

Exclusion Criteria:

Presence of exacerbation in the last 4 weeks.
Antibiotic treatment in the last 4 weeks
Use of oral corticosteroids in the last 4 weeks
Concomitant terminal illness.
Current cigarette smoking
Active allergic bronchopulmonary aspergillosis
Diagnosis of tuberculosis or active non-tuberculous Mycobacterial infection

Accepts Healthy Volunteers

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

Patients with diagnosis of non-CF bronchiectasis will be recruited from the outpatient clinic of the Pneumology Service of the Sant Pau Hospital in Barcelona

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oriol Sibila, MD PhD	Contact	0034647914193		osibila@santpau.cat

Overall Officials

Name	Affiliation	Role
Oriol Sibila, MD PhD	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de la Santa Creu i Sant Pau	Recruiting	Barcelona	Barcelona	08025	Spain

Condition Browse Module

MeSH Terms

ID	Term
D001987	Bronchiectasis

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

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