Severe and very severe COPD
Conditions
Interventions
Trade Name: Viani forte 50 µg/500µg Diskus
Product Name: Viani forte 50µg/500µg Diskus
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Salmeterol (as salmeterol xinafoate)
C
Sponsors
GlaxoSmithKline GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Subject must have a diagnosis of COPD based on the American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria. 2. 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 hysterctomy, or females who are post-menopausal 3. Have diagnosed COPD stage III or IV according to GOLD criteria: a baseline post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: 1. Known other respiratory disorders or signs for other respiratory disorders (e.g. asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis, bronchoectasis). 2. Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and systemic lupus erythematosus). 3. Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ) 4. Having undergone lung transplant) or subjects scheduled for surgery. 5. Concurrent medication from Visit 1 and for the duration of the study with any of the prohibited medications listed in Section 5.6.2 6. Subjects receiving chronic or prophylactic antibiotic therapy. 7. Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subjects safety. 8. Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. 9. History of depression. 10. History or presence of clinically significant drug sensitivity or clinically significant allergic reaction to corticosteroids or salmeterol. 11. Moderate or severe COPD exacerbation (requiring corticosteroids or increased dosage of corticosteroids and/or antibiotics or hospitalisation)within the 4 weeks prior to Visit 1 12. Lower respiratory tract infection within the 4 weeks prior to Visit 1. 13. Pregnant or lactating female and female with childbearing potential. 14. Subject is a participating investigator, sub-investigator, study co-ordinator, or other employee of a participating investigator, or is an immediate family member of the before mentioned. Subject is an employee of GSK. 15. Subject participated in an investigational drug study within 30 days prior to Visit 1. Any factor, which in the opinion of the investigator would jeopardise the evaluation or safety or be associated with poor adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain data on the frequency and variability of exacerbations in severe and very severe COPD patients (GOLD stage III und IV) receiving SFC or Sal/FP with individual standard therapy.;Secondary Objective: To assess adherence of patients with COPD (GOLD stage III and IV) taking either SFC in fix combination or Sal/FP from separate inhalers. To assess the health care utilisation costs in patients with COPD (GOLD stage III and IV).;Primary end point(s): Frequency of exacerbations (Grade II and III) according to Rodriguez-Roisin | — |
Countries
Germany
Outcome results
None listed