Biomarkers of iNOS Activity in COPD, Asthma, Healthy Control

Exclusion Criteria

• •Healthy volunteers (smokers)
• •A healthy smoking subject will not be eligible for inclusion in this study if any of the following criteria apply:
• •1. As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
• •2. The subject has participated in a study with a new molecular entity during the previous 4 months or any other clinical trial during the previous 3 months. In case of a non invasive, clinical trial not involving new molecular entities a 1 month washout will be sufficient.
• •3. The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
• •4. The subject regularly, or on average, drinks more than 21 units per week
• •5. The subjects is taking any medication (whether prescribed or over-the-counter), any herbal medication (incl. St.John's Wort) or high doses of nutritional supplements which could interfere with the study tests, within 14 days of study entry and throughout the study.
• •6. The subject has received oral steroids within 3 months of study entry
• •7. The subject significant risk factors for Hepatitis B or C infection
• •8. The subject has significant risk factors for HIV infection.
• •COPD (smokers)
• •A smoking COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
• •1. As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
• •2. The subject has participated in a study with a new molecular entity during the previous 4 months or any other clinical drug trial during the previous 3 months. In case of a non invasive, clinical trial not involving new molecular entities a 1 month washout will be sufficient.
• •3. The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
• •4. The subject regularly, or on average, drinks more than 21 units per week
• •5. The subjects is taking any medication (whether prescribed or over-the-counter), any herbal medication (incl. St.John's Wort) or high doses of nutritional supplements which could interfere with the study tests, within 14 days of study entry and throughout the study.
• •6. The subject has received oral steroids within 3 months of study entry.
• •7. The subject has history of an upper respiratory infection (including sinusitis) within 4 weeks prior to study entry.
• •8. The subject has been hospitalised for a COPD exacerbation within 3 months of study entry
• •9. Subject is unable to abstain from xanthines (theophylline), inhaled long acting beta-2 agonists and tiotropium from 4 hours prior to first study visit until completion of study visit
• •10. For the non-steroid group, inhaled steroid use is not permitted within 14 days of study entry until completion of the study
• •11. The subject significant risk factors for Hepatitis B or C infection
• •12. The subject has significant risk factors for HIV infection. Asthma (non-smokers)
• •A non smoking asthmatic subject will not be eligible for inclusion in this study if any of the following criteria apply:
• •1. The subject has a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with either hypercapnoea, respiratory arrest or hypoxia seizures.
• •2. Subjects have a symptomatic pattern suggestive of poorly controlled asthma that in the opinion of the investigator precludes them from entry into the study
• •3. The subject received inhaled steroid within 14 days of study entry. Any subject who needs inhaled, intranasal or topical steroids between screening and study start should not be included in the study.
• •4. As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
• •5. The subject has participated in a study with a new molecular entity during the previous 4 months or any other clinical drug trial during the previous 3 months. In case of a non invasive, clinical trial not involving new molecular entities a 1 month washout will be sufficient.
• •6. The subject has donated a unit of blood within the previous month or intends to donate in the month after completing the study
• •7. The subject regularly, or on average, drinks more than 21 units per week
• •8. The subjects is taking any medication (whether prescribed or over-the-counter), any herbal medication (incl. St.John's Wort) or high doses of nutritional supplements which could interfere with the study tests, within 14 days of study entry and throughout the study.
• •9. The subject has received oral steroids within 3 months of study entry
• •10. The subject has history of a respiratory infection (including sinusitis) within 4 weeks prior to study entry
• •11. The subject has been hospitalised for a asthma exacerbation within 3 months of study entry
• •12. The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen or a positive medical history for hepatitis C antibody or hepatitis B surface antigen.
• •13. History of current or past drug or alcohol abuse.
• •14. Subject is unable to abstain from xanthines (theophylline), inhaled long acting beta-2 agonists and tiotropium from 4 hours prior to first study visit until completion of study visit.
• •15. Current or past smoking history.
• •16. The subject significant risk factors for Hepatitis B or C infection
• •17. The subject has significant risk factors for HIV infection.