COPD, Asthma, wheezing, airway inflammation, smoking
Conditions
Interventions
Sponsors
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  Shortness of breath typically developing on exertion  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
| Measure | Time 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
| Measure | Time 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 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. | — |
Contacts
Clinical Research Fellow 'Electronic Nose' Academic Medical Center (AMC) University of Amsterdam Department of Pulmonology F5-260 P.O.Box 22660