sample collection in smoking asthma

Conditions: Asthma

Summary: this study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers and normal healthy subjects, to compare the biological markers of disease and inflammation.


Eligibility criteria:
inclusion criteria (healthy subjects): * male or female, between 18 and 55 years of age, inclusive. * no clinically significant abnormalities. * able to produce an adequate induced sputum sample. * no history of chronic respiratory disease including asthma. * no history of allergic symptoms e.g., allergic rhinitis, eczema. * no other acute illness in the 6 weeks prior to visit 1. additional inclusion criterion for healthy smoking subjects * be a smoker for \>/= 1 year. additional inclusion criteria (persistent asthmatic subjects): * no contraindications to the procedures in this study. * symptoms compatible with asthma for at least 6 months prior to screening * pre-bronchodilator fev1 \>/=50% predicted at visit 1. * clinically stable asthma for at least 6 weeks prior to visit 1. * no acute illness including asthma exacerbation requiring augmentation of therapy in the 6 weeks prior to visit 1. * on current asthma controller therapy for \>/= 6 weeks prior to visit 1. additional inclusion for steroid naïve asthmatics (smoking or non-smoking) * must not have received a regular course of inhaled or oral corticosteroids for at least 3 months prior to visit 1. additional inclusion for smoking asthmatics * be a smoker for \>/= 1 year prior to visit 1. exclusion criteria (healthy): * history of any clinically significant medical illness or medical disorders. * diagnosis of chronic obstructive pulmonary disease (copd), cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms. * bronchodilator response of \>/=12% and at least 200 ml from baseline or an fev1 value \<85% of predicted value at visit 1. * positive urine pregnancy screening result. * recent history (within previous 6 months) of alcohol or drug abuse. * positive urine toxicology screen for substances of abuse * positive serology test for hiv antibodies, hepatitis b surface antigen (hbsag), or hepatitis c virus antibody (anti-hcv) at visit 1. * received an experimental antibody or biologic therapy within the 6 months prior to visit 1, or received any other experimental therapy or new investigational agent within 60 days of visit 1. * is an employee or family member of the investigator, study centre or sponsor. * any condition that, in the opinion of the investigator, would complicate or compromise the study, or the well-being of the subject. * use of any antioxidants within 1 week of visit 1 and throughout the study period. * known allergies, hypersensitivity, or intolerance to short acting β-agonists (saba). additional exclusion criterion for healthy non-smoking subjects * subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to visit 1. additional exclusion criteria (persistent asthma subjects): * diagnosis of allergic bronchopulmonary aspergillosis (abpa), allergic bronchopulmonary mycosis (abpm), or occupational asthma. * diagnosis of copd, cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms. * use of theophylline, n-acetyl cysteine, or any other anti-oxidants within 1 week of visit 1 and throughout the study period. * positive test for tuberculosis at visit 1. additional exclusion criterion for non-smoking asthmatic subjects * subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to visit 1.