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The electronic nose as a diagnostic tool in the discrimination of COPD and controls


- candidate number3202
- NTR NumberNTR1282
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-apr-2008
- Secondary IDs07/153 METC AMC
- Public TitleThe electronic nose as a diagnostic tool in the discrimination of COPD and controls
- Scientific TitleThe electronic nose as a diagnostic tool in the discrimination of COPD and controls
- ACRONYMThe electronic nose in the discrimination of COPD and controls
- hypothesisWe postulate that exhaled breath sampling by an electronic nose can distinguish:
1. Patients with COPD GOLD stadium 2-3, who do not use inhaled corticosteroids
2. Patients with COPD GOLD stadium 2-3, who use inhaled corticosteroids
3. Patients with COPD GOLD stadium 2-3, who are smoking
4. Patients with COPD GOLD stadium 2-3, who are not smoking
5. Asymptomatic controls who are smoking (>10 Packyears (PY))
6. Non-smoking asymptomatic controls (< 5 PY)
7. Non-smoking patients with allergic asthma (<5 PY), who use inhaled corticosteroids
- Healt Condition(s) or Problem(s) studiedRespiratory tract infection, Asthma, Smoking, COPD, Electronic nose
- Inclusion criteria1. COPD patients
2. A minimum of ten patients 40-75 years with moderate to severe COPD:
• Smoking 10 cigarettes/day, > 10 pack years or
• Non-smoking (> 10 pack years, > 12 months)
• Matching GOLD severity step 2:
o Presence of symptoms of
 Shortness of breath typically developing on exertion
 Occasional occurrence of cough and sputum production
o Postbronchodilator 50% < FEV1 < 80% predicted
o Postbronchodilator FEV1/FVC < 0.70
• Matching GOLD severity step 3:
o Presence of symptoms of
 Greater shortness of breath
 Reduced exercise capacity
 Fatigue and
 Repeated exacerbations that affect quality of life
o Postbronchodilator 30% < FEV1 < 50%
o Postbronchodilator FEV1/FVC < 0.70

Controls
A minimum of ten asymptomatic age-matched > 40 years controls:
• Non-smoking (< 5 pack-years, > 12 months) and
• Smoking (> 10 pack-years, >10 cigarettes/day) and
• Ex-smoking (> 10 pack years, > 12 months)
• A negative history on lung diseases
• A negative history on any other acute or chronic illness
• Prebronchodilator FEV1 > 80% predicted
• FEV1/FVC > 0.70
• Absence of bronchial hyperresponsiveness demonstrated by PC20 > 4 mg/ml
• Negative skin prick test or RAST to common environmental allergens
• Absence of symptoms of
o Shortness of breath
o Chest pains
o Cough
o Sputum production
o Reduced exercise capacity
o Fatigue

Asthma
A minimum of ten asthmatic patients > 18 years:
• Non-smoking (< 5 pack-years, > 12 months) and
• A negative history on other lung diseases than asthma
• A negative history on any other acute or chronic illness than asthma
• Prebronchodilator FEV1 > 50% predicted
• Presence of bronchial hyperresponsiveness demonstrated by PC20 < 8 mg/ml
• Positive skin prick test or RAST to one or more common environmental allergens
• Chronic use of inhaled corticosteroids
- Exclusion criteriaTwo or more of the following:
• Severe cardiovascular disease, history or present
• Myocardial infarction
• Coronary bypass surgery
• CVA
• Pulmonary embolism and deep venous thrombosis
• Heart failure
• Diabetes mellitus (documented in the past)
• Hypercholesterolaemia (documented in the past)
• Systemic inflammatory disease
• Cancer diagnosed and treated within 5 years, or known incomplete remission if earlier
• Any active inflammation

One or more of the following:
• The use of oxygen.
• For COPD-patients: GOLD-stadium I or IV.
• For controls: Reversibility in FEV1 by 400 ug of inhaled salbutamol > 12 % pred. (7)
• For asthma patients: the use of oral corticosteroids
• History of other pulmonary diseases or abnormalities eg tuberculosis, bronchiectasis, asthma, lung cancer, sarcoidosis
• Presence or recent history (4 weeks) of paradontitis
• History of upper or lower respiratory infection in the past 4 weeks.
• For patients: Exacerbation in the past 8 weeks
The definition of an exacerbation of COPD will follow the criteria by Anthonisen et al (6). This includes two or more of the following symptoms: worsening dyspnoea, increased sputum purulence, increased sputum volume, or one of these plus one of: upper respiratory tract infection during the past 5 days, fever without other cause, increased wheeze, increased cough or increased heart or respiratory rate by more than 20%.
• The presence of right-sided heart failure as indicated by physical examination.
• Inhalation medication < 12 hours (short-acting bronchodilation) or < 24 hours (long-acting) or < 3 hours inhaled corticosteroids
• Antihistamines, theofylline, and antibiotic use in the past 2 days
• Eating (including chewing gum), drinking, smoking, brushing teeth < 3 hours before measurements
• Bad technique in previous lung function tests
• Lack of comprehension of the study and measurements
• Pregnancy
• Hyper- or hypothyroid function or use of Levothyroxine
• Renal insufficiency
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2007
- planned closingdate31-okt-2008
- Target number of participants120
- InterventionsNone: diagnostic study.
- Primary outcomeElectronic nose: the Cyranose 320 (Smith Detections, Pasadena, Ca, USA), a handheld portable chemical vapor analyzer, containing a nanocomposite sensor array with 32 polymer sensors. When exposed to a gas mixture, the sensors will swell and thus change the electrical conductance, resulting in a unique smell-print. These measurements are stored in an on-board database and can be analyzed by the pattern recognition software as well as by offline statistics software (see analysis section).
Breathing maneuver: patients will breathe normally through a mouthpiece, connected to a three-way non-re-breathing valve and an inspiratory VOC-filter (A2, North Safety, NL) for 5 minutes. After a single deep inspiration the patient exhales a vital capacity volume into a Tedlar bag connected to the expiratory port. Sampling: Within 30 minutes the electronic nose will be connected to the Tedlar bag, followed by 1 minute sampling of the exhaled air.
Measurements as described above will be performed in duplo.
- Secondary outcomeSkin prick test/RAST: using a panel of 10 common airborne allergens (Grass mix, tree mix, Aspergillus Fumigatus, Alternaria Alternate, house dust mite, Cladosporium, cat, dog, latex, rabbit, guinea pig, cockroach (Blatella Germanica)). Spirometry: pre- and postbronchodilator spirometry (if not available from past 2 weeks), performed by standardized methods (ERS/ATS). Measurements will be performed before and after 400 μg of inhaled salbutamol.
Bronchial responsiveness by methacholine challenge (if not available from past 2 months) (for controls and asthma patients), using a standardized procedure (ERS/ATS).
CO-diffusion capacity will be measured by a single-breath, breath holding technique. Symptoms: validated questionnaires for assessing symptoms of COPD, smoking history and for co-morbidity will be used. HbCO measurement in capillary blood.
- TimepointsAll measurements take place in a single visit for COPD patients.
In addition, controls and asthma patients perform a metacholine test on a separate day within one month.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESM.D. Niki Fens
- CONTACT for SCIENTIFIC QUERIESM.D. Niki Fens
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Asthma Foundation
- Publications- N. Fens, MD1, M.P.C. van der Schee, BSc1, D. Cheung, MD,PhD2, E. Dijkers1, S.B. de Nijs1, P.J.E. Bindels, MD,PhD1, E.H.D. Bel, MD,PhD1 and P.J. Sterk, MD,PhD1. 1Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands and 2Vlietland Hospital, Schiedam, Netherlands. COPD can be Discriminated from Controls by Fingerprint Analysis of Volatile Organic Compounds in Exhaled Air using eNose Technology. Abstract ATS 2008.
- N. Fens, N.Fens@amc.nl, MD1, M.P.C. van der Schee, M.P.C.van_der_Schee@lumc.nl1, S.B. de Nijs, S.B.deNijs@amc.nl1, E. Dijkers, E.Dijkers@amc.nl1, Prof. Dr E.H. Bel, E.H.Bel@amc.nl, MD1 and Prof. Dr P.J. Sterk, P.J.Sterk@amc.nl, MD1. 1Respiratory Medicine, Academic Medical Center, Amsterdam, Netherlands. Exhaled breath molecular profiling in measuring inflammatory status in COPD http://www.ncbi.nlm.nih.gov/pubmed/19713445?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
- Brief summaryBackground: Recently, ‘omics’ techniques became available, based on an empirical approach of analysis of the overall molecular characteristics of biological samples, including exhaled breath. By the use of arrays of sensors, combined with pattern recognition algorithms, a sample of breath can be analyzed for its volatile organic compounds by an electronic nose, resulting in a specific ‘smell-print’. The usage of the electronic nose in COPD can potentially improve diagnostics and monitoring.
Hypothesis: We postulate that exhaled breath sampling by an electronic nose can distinguish the following groups of patients: patients with COPD (GOLD stadium II or III; smoking or ex-smoking; using or not using inhaled corticosteroids), smoking and non-smoking asymptomatic controls and asthma patients.
Aim: The aim of this study is to provide evidence that the electronic nose is able to discriminate between the groups that are mentioned above in a cross-sectional study. Outcome parameters: The primary outcome parameter is the smell-print provided by the electronic nose, together with the results of the on-board and offline statistical analysis.
Subjects: A minimum of ten subjects in each category mentioned above are required. All patients and controls will be 40-75 years.
Design: Cross-sectional case-reference design in order to train the electronic nose in discriminating between several subgroups of COPD, controls and asthma.
Methods: Electronic nose: the Cyranose 320 (Smith Detections, Pasadena, Ca, USA). When exposed to a gas mixture, the sensors will swell and thus change the electrical conductance, resulting in a unique smell-print. These measurements can be analyzed by the pattern recognition software as well as by offline statistics software.
Breathing maneuver: patients will breathe normally through a mouthpiece, connected to a three-way non-re-breathing valve and an inspiratory VOC-filter (A2, North Safety, NL) for 5 minutes. The patient exhales a vital capacity volume into a Tedlar bag connected to the expiratory port.
Sampling: Within 30 minutes the electronic nose will be connected to the Tedlar bag, followed by 1 minute sampling of the exhaled air.
Skin prick test/RAST: using a panel of 10 common airborne allergens.
Spirometry and reversibility: performed by standardized ATS/ERS methods.
Bronchial responsiveness: by methacholine challenge using a standardized ATS/ERS procedure.
CO-diffusion capacity: single-breath, breath holding technique.
Symptoms: validated questionnaires for assessing symptoms of COPD, smoking habits and for co-morbidity.
Ethics: The LUMC and AMC Medical Ethics Committees have approved the protocol entitled: ‘The electronic nose in the diagnostic assessment of airway disease’ (05/119 LUMC, 07/153 AMC).
- Main changes (audit trail)
- RECORD16-apr-2008 - 15-okt-2009


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