Influence Of Salmeterol Xinafoate/Fluticasone Propionate (50/500 µg BID) On The Course Of The Disease And Exacerbation Frequency In COPD Patients Gold Stage III And IV

Inclusion criteria

• Subject must have a diagnosis of COPD based on the American Thoracic Society (ATS)/ European Respiratory Society (ERS) criteria.
• Male or female subjects, aged >=40 years. Females must be of Non Child Bearing Potential. The definition of Non Child Bearing Potential is as following: Females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation or hysterectomy, or females who are post-menopausal.
• Have diagnosed COPD stage III or IV according to GOLD criteria: a baseline post-bronchodilator Forced Expiratory Volume, measured at 1 second (FEV1) <50% of predicted normal and a baseline post- bronchodilator FEV1/Inspiratory Vital Capacity (IVC) ratio <70%.
• Have experienced at least 2 moderate or severe COPD exacerbations leading to medical consultation (requiring oral corticosteroids or increasing dosage of oral corticosteroids and/or antibiotics or hospitalization) within the 12 months preceding Visit 1.
• Have stable COPD medication within 4 weeks prior to Visit 1 (no new medication added and no dosage changes in medication).
• Current or ex-smokers with a smoking history of at least 10 pack years (number of pack years = [number of cigarettes per day / 20] x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
• Are currently managed at home (outpatients), are ambulatory and able to travel to the clinic. Subjects can be treated with all relevant COPD medication. This includes vaccines, inhaled short-acting beta-2-agonists as needed, short-acting or long-acting anticholinergics (tiotropium), systemic beta-2-agonists, theophylline, mucolytics, antioxidants, beta-1-agonists (for cardiovascular indication), non-invasive ventilation, long term oxygen therapy and can have Cor Pulmonale.
• A signed and dated written informed consent is obtained prior to participation.
• Able to comply with the requirements of the protocol and be available for study visits over 52 weeks.

Exclusion criteria

• Known other respiratory disorders or signs for other respiratory disorders (e.g. asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis, bronchoectasis).
• Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and systemic lupus erythematosus).
• Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
• Having undergone lung surgery (e.g. lung resection including lung volume reduction surgery, lung transplant) or subjects scheduled for surgery.
• Concurrent medication from Visit 1 and for the duration of the study with any of the prohibited medications: monoamine oxidase inhibitors and tricyclic antidepressants, and ritonavir (a highly potent cytochrome P450 3A4 inhibitor).
• Subjects receiving chronic or prophylactic antibiotic therapy.
• Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety.
• Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
• History of depression.
• History or presence of clinically significant drug sensitivity or clinically significant allergic reaction to corticosteroids or salmeterol.
• Moderate or severe COPD exacerbation (requiring corticosteroids or increased dosage of corticosteroids and/or antibiotics or hospitalization) within the 4 weeks prior to Visit 1
• Lower respiratory tract infection within the 4 weeks prior to Visit 1 .
• Pregnant or lactating female and female of childbearing potential.
• Subject is a participating investigator, sub-investigator, study coordinator, or other employee of a participating investigator, or is an immediate family member of the before mentioned. Subject is an employee of GlaxoSmithKline (GSK).
• Subject participated in an investigational drug study within 30 days prior to Visit 1