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Persistent AsthmaNCT02026336

E-nose and Inflammatory Asthma Phenotypes

A study testing electronic nose in people with Persistent Asthma, run by Astrid Crespo at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Persistent Asthma
What is being tested?
electronic nose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteSpain
Study dates
Jun 2011to Jun 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Vicente Plaza

    Barcelona, 08025

Other trials in Spain

About this study

Official title: Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer

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?

Read the 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.

Being tested
electronic nose
Keywords
asthma; inflammation; electronic nose
Medical subject headings
Asthma, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electronic noseOther

    Also called Cyranose 320®; Smith Detections, Pasadena, CA

    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.

Study groups in NCT02026336
Study groupRoleWhat they receive
enoseNo interventionElectronic nose can discriminate the inflammatory asthma phenotypes, supporting their potential as a non-invasive alternative tool to induced sputum.
Receives: Other: electronic nose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2014 (estimated)
  2. Study startJun 2011
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02026336
Sponsor's protocol ID
10/122/1161
Status last verified
Dec 2013
First submitted
28 Dec 2013
Last updated
1 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19713445

  • 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.

    PubMed 18834643

  • 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.

    PubMed 20937641

  • 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.

    PubMed 21413563

  • 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.

    PubMed 20081096

  • 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.

    PubMed 21749985

  • 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.

    PubMed 22561835

  • 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.

    PubMed 24337046

  • 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.

    PubMed 26817140

Questions about this trial

What is this clinical trial studying?

A study testing electronic nose in people with Persistent Asthma, run by Astrid Crespo at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02026336, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2014.

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