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E-nose and Inflammatory Asthma Phenotypes

Primary Purpose

Persistent Asthma

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
electronic nose
Sponsored by
Astrid Crespo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Persistent Asthma focused on measuring asthma; inflammation; electronic nose

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults with persistent asthma, defined as per the Global INitiative for Asthma Management (GINA) criteria, and specifically with positive bronchodilator test, or a daily peak expiratory flow (PEF) variability greater than 20%, or a positive methacholine challenge test documented in case history. Subjects were consecutively enrolled from the outpatient visits of a specialized Asthma Unit located in a tertiary University Hospital.

Exclusion Criteria:

Subjects were excluded if they had a respiratory tract infection or asthma exacerbation within 30 days prior to inclusion or were receiving oral steroids or immunosuppressive treatments.

Sites / Locations

  • Vicente Plaza

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

enose

Arm Description

Electronic nose can discriminate the inflammatory asthma phenotypes, supporting their potential as a non-invasive alternative tool to induced sputum.

Outcomes

Primary Outcome Measures

Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer
The recognition of volatile organic compound profiles in exhaled air by an electronic nose device can discriminate the inflammatory phenotype of patients with persistent asthma.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2013
Last Updated
December 31, 2013
Sponsor
Astrid Crespo
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1. Study Identification

Unique Protocol Identification Number
NCT02026336
Brief Title
E-nose and Inflammatory Asthma Phenotypes
Official Title
Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Astrid Crespo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with persistent asthma have different inflammatory phenotypes. The electronic nose is a new technology capable of distinguishing volatile organic compound breath-prints in exhaled breath among different pulmonary diseases. Question of the study. Is the electronic nose breath-print analysis able to discriminate among different inflammatory asthma phenotypes?
Detailed Description
Materials/patients and methods. Fifty-two consecutively enrolled patients with persistent asthma were included in a cross-sectional proof of concept study. Inflammatory asthma phenotypes were recognized by inflammatory cell counts in induced sputum. Breath-prints were analyzed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values. Receiver Operating Characteristics (ROC) was calculated. Legal and ethical aspects The study was conducted in accordance with the Declaration of Helsinki principles (18th Word Medical Assembly, 1964) and was approved by the Clinical Research Ethics Committee (approval number: IIBSP/10/122/1161) of our institution. The participants provided their written informed consent to participate in this study and personal identification data were anonymized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Asthma
Keywords
asthma; inflammation; electronic nose

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enose
Arm Type
No Intervention
Arm Description
Electronic nose can discriminate the inflammatory asthma phenotypes, supporting their potential as a non-invasive alternative tool to induced sputum.
Intervention Type
Other
Intervention Name(s)
electronic nose
Other Intervention Name(s)
Cyranose 320®; Smith Detections, Pasadena, CA
Intervention Description
Exhaled gas to assess e-nose VOC profiles was collected as described. Briefly, patients breathed through a mouthpiece into a 2-way nonrebreathing valve (Hans rudolph 2700, Hans rudolph, Kansas City, Mo) with an inspiratory VOC filter and an expiratory silica reservoir to dry the expired air. Expiratory air was collected in a 10-L "Tedlar bag". Within not more than 10 minutes, the bag was connected to the e-nose device (Cyranose 320®; Smith Detections, Pasadena, CA), provided with a 32 organic polymeric nano-composite sensor array, for 5 minutes and changes in the nano-sensor electrical resistance generated a breath-print VOC profile.
Primary Outcome Measure Information:
Title
Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer
Description
The recognition of volatile organic compound profiles in exhaled air by an electronic nose device can discriminate the inflammatory phenotype of patients with persistent asthma.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults with persistent asthma, defined as per the Global INitiative for Asthma Management (GINA) criteria, and specifically with positive bronchodilator test, or a daily peak expiratory flow (PEF) variability greater than 20%, or a positive methacholine challenge test documented in case history. Subjects were consecutively enrolled from the outpatient visits of a specialized Asthma Unit located in a tertiary University Hospital. Exclusion Criteria: Subjects were excluded if they had a respiratory tract infection or asthma exacerbation within 30 days prior to inclusion or were receiving oral steroids or immunosuppressive treatments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Plaza
Organizational Affiliation
Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau. Institut d'Investigació Biomédica Sant Pau (IIB Sant Pau). Universitat Autònoma de Barcelona, Department of Medicine. Barcelona Respiratory Network (BRN). Barcelona, Spain.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vicente Plaza
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19713445
Citation
Fens N, Zwinderman AH, van der Schee MP, de Nijs SB, Dijkers E, Roldaan AC, Cheung D, Bel EH, Sterk PJ. Exhaled breath profiling enables discrimination of chronic obstructive pulmonary disease and asthma. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1076-82. doi: 10.1164/rccm.200906-0939OC. Epub 2009 Aug 27.
Results Reference
background
PubMed Identifier
18834643
Citation
Dragonieri S, Annema JT, Schot R, van der Schee MP, Spanevello A, Carratu P, Resta O, Rabe KF, Sterk PJ. An electronic nose in the discrimination of patients with non-small cell lung cancer and COPD. Lung Cancer. 2009 May;64(2):166-70. doi: 10.1016/j.lungcan.2008.08.008. Epub 2008 Oct 1.
Results Reference
background
PubMed Identifier
20937641
Citation
Petsky HL, Cates CJ, Lasserson TJ, Li AM, Turner C, Kynaston JA, Chang AB. A systematic review and meta-analysis: tailoring asthma treatment on eosinophilic markers (exhaled nitric oxide or sputum eosinophils). Thorax. 2012 Mar;67(3):199-208. doi: 10.1136/thx.2010.135574. Epub 2010 Oct 11.
Results Reference
background
PubMed Identifier
21413563
Citation
Executive Committee GEMA 2009. GEMA 2009 (Spanish guideline on the management of asthma). J Investig Allergol Clin Immunol. 2010;20 Suppl 1:1-59. No abstract available.
Results Reference
background
PubMed Identifier
20081096
Citation
Montuschi P, Santonico M, Mondino C, Pennazza G, Mantini G, Martinelli E, Capuano R, Ciabattoni G, Paolesse R, Di Natale C, Barnes PJ, D'Amico A. Diagnostic performance of an electronic nose, fractional exhaled nitric oxide, and lung function testing in asthma. Chest. 2010 Apr;137(4):790-6. doi: 10.1378/chest.09-1836. Epub 2010 Jan 15.
Results Reference
background
PubMed Identifier
21749985
Citation
Ibrahim B, Basanta M, Cadden P, Singh D, Douce D, Woodcock A, Fowler SJ. Non-invasive phenotyping using exhaled volatile organic compounds in asthma. Thorax. 2011 Sep;66(9):804-9. doi: 10.1136/thx.2010.156695. Epub 2011 Jul 11.
Results Reference
background
PubMed Identifier
22561835
Citation
Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012 May 4;18(5):716-25. doi: 10.1038/nm.2678.
Results Reference
background
PubMed Identifier
24337046
Citation
Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12. Erratum In: Eur Respir J. 2014 Apr;43(4):1216. Dosage error in article text. Eur Respir J. 2018 Jul 27;52(1): Eur Respir J. 2022 Jun 9;59(6):
Results Reference
background
PubMed Identifier
26817140
Citation
Plaza V, Crespo A, Giner J, Merino JL, Ramos-Barbon D, Mateus EF, Torrego A, Cosio BG, Agusti A, Sibila O. Inflammatory Asthma Phenotype Discrimination Using an Electronic Nose Breath Analyzer. J Investig Allergol Clin Immunol. 2015;25(6):431-7.
Results Reference
derived
Links:
URL
http://Www.ginasthma.org/.
Description
GINA. Global strategy for asthma management and prevention, global initiative for asthma (GINA)

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E-nose and Inflammatory Asthma Phenotypes

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