Mild to moderate Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
No therapeutic intervention, only DIAGNOSTIC tests. The indextest and the referencetest will both be assessed in a group of patients.
Sponsors
Dept. of Repiratory Medicine
Academic Medical Center
University of Amsterdam
P.O. Box 22700
NL-1100 DE Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of COPD conform the diagnostic criteria of the Global Initiative for Obstructive Lung Disease for stage I or II (mild to moderate) COPD www.goldcopd.org. 2. Age > 40 years 3. Have post-bronchodilator FEV1 > 1,5 liters and at least 50% of predicted for height, age and gender conform the ERS normal value (see appendix 1 for formula). 4. Smoking history > 20 pack-year* 5. Current smokers as well as ex-smokers. 6. As determined by the investigator, are capable and willing to: - perform all of the techniques necessary to measure lung function - administer the dry powder mannitol 7. Are capable of, and have given informed consent to participate in the study. 8. The subject must be in stable clinical condition at the time of, and for a period of 14 days prior to, their recruitment into the study. Stable clinical condition is defined as lack of: - change in sputum production (volume, color, consistency); - increased cough; - worsening dyspnoea; - increased malaise, fatigue or lethargy; - reduction in exercise tolerance; - fever; - antibiotic treatment (for respiratory infection). 9. No use of oral or inhaled corticosteroids 4 weeks before the first visit.
Exclusion criteria
Exclusion criteria: 1. Subjects receiving treatment with inhaled corticosteroids of oral corticosteroids within the last 4 weeks. 2. Subjects who have had an exacerbation or a chest infection within the last 2 weeks prior to the study. 3. Subjects who receiving antibiotic treatment for respiratory infection. 4. Known diagnosis of asthma or allergic rhinitis. 5. Myocardial infarction in the six months prior to enrolment. 6. Cerebral vascular accident in the six months prior to enrolment. 7. Ocular surgery in the three months prior to enrolment. 8. Active tuberculosis (TB). 9. Lung cancer or any other malignancies, which are considered by the investigator as a contraindication to participating in the study. 10. Lung disease other than COPD 11. Uncontrolled insulin-dependent or non-insulin dependent diabetes. 12. Inability to obtain informed consent from the subject or subject’s authorized representative. 13. Known intolerance to mannitol. 14. Uncontrolled hypertension-systolic blood pressure (BP)> 200 mmHg and or diastolic BP> 100 mmHg. 15. Have had major abdominal or chest surgery in the three months prior to enrolment. 16. Have known cerebral, aortic or abdominal aneurysm. 17. Subjects receiving treatment with béta-blockers. 18. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic tests: - Mannitol (Osmohale) challenge test (Index test). - Sputum induction to assess the degree of airway inflammation (Reference test) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Influence of the mannitol challenge test on induced sputum (repeatability) - exhaled nitric oxide (NO) measured according to the ATS recommendations. - serum inflammatory proteins: albumin, alpha2 macroglobulin, Luminex assay. - Electronic nose: the Cyranose 320. A vital capacity volume is analyzed as smell print. - GC-MS: gas chromatography and mass spectrometry of breath samples (Philips Medical Research, Eindhoven, The Netherlands). | — |
Contacts
Public ContactS.B. Nijs, de
Dept. Pulmonology Academic Medical Center (C2-435) Meibergdreef 9
Outcome results
None listed