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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23287
Enrollment
120
Registered
2008-04-16
Start date
2007-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Asthma, wheezing, airway inflammation, smoking

Interventions

Sponsors

Academic Medical Center Amsterdam, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 &#61607; Shortness of breath typically developing on exertion &#61607; Occasional occurrence of cough and sputum production o Postbronchodilator 50% 40 years controls: • Non-smoking ( 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 ( 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 criteria

Exclusion criteria: Two 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

Design outcomes

Primary

MeasureTime frame
Electronic 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

MeasureTime frame
Skin 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 &#956;g 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.

Contacts

Public ContactNiki Fens

Clinical Research Fellow 'Electronic Nose' Academic Medical Center (AMC) University of Amsterdam Department of Pulmonology F5-260 P.O.Box 22660

N.Fens@amc.nl+31 (0)20 5664359

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)