Rosiglitazone Versus Theophylline in Asthmatic Smokers

Exclusion Criteria

• •Asthma exacerbation or a respiratory tract infection within four weeks of screening.
• •Type 1 or type 2 diabetes mellitus.
• •Women who are lactating, pregnant, or planning to become pregnant.
• •Clinically significant renal or hepatic laboratory values (e.g. AST/ALT/total bilirubin/AP \> 2.5 times normal values).
• •Anaemia (\< 11 g/dL for males or \< 10 g/dL for females)
• •Contraindications to treatment as outlined in any of the product labels
• •Prior history of severe oedema or serious fluid related event (e.g., heart failure) associated with any TZD
• •The subject has a history of significant hypersensitivity to study drugs
• •Presence of unstable or severe angina or congestive heart failure (NYHA class III/IV) or evidence or history of known congestive heart failure (NYHA class I-IV) or an abnormal electrocardiogram (ECG), as determined by the Investigator, or subjects who have had new cardiac events (such as MI, new CHF, PTCA, CABG) within 6 months of screening.
• •History or suspicion of current drug abuse or alcohol abuse within the last 6 months.
• •History suggestive of active infection or non-asthma lung pathology
• •Clinically significant renal disease, metabolic syndrome, cirrhosis (Child-Pugh Class B/C), hypertension or any other clinically significant cardiovascular, neurological, endocrine, or haematological abnormalities that are uncontrolled on permitted therapy.
• •Risk factors for human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection at Screening (Visit 1)
• •Subjects who are morbidly obese, defined as having a body mass index (BMI) \> 40 kg/m2
• •Unable to perform spirometry
• •Subjects who require treatment with any of the following asthma medications from Screening (Visit 1) until study completion:
• •* Inhaled cromolyn sodium or nedocromil;
• •* Ipratropium bromide;
• •* Xanthines (theophylline preparations);
• •* Leukotriene modifiers;
• •* Long-acting inhaled beta2-agonists (salmeterol, formoterol);
• •* Oral beta2-agonists.
• •Treatment with oral, intravenous or intra-articular corticosteroids within 6 weeks of Screening or thereafter.
• •Subjects who have been taking in excess of 1000 μg daily of beclomethasone (or equivalent) within 6 weeks of Screening