A 12-month open-label, randomized parallel-group study to investigate the influence of salmeterol/fluticasone either in fixed combination (SFC500/50 µg bid) or seperately (SAL 50 µg and FP 500 µg bid) via Diskus inhaler(s) on course of the disease and frequency of exacerbations in subjects with severe and very severe COPD (GOLD Stage III and IV) - VIVESCO
- Conditions
- Severe and very severe COPD
- Registration Number
- EUCTR2007-003597-25-DE
- Lead Sponsor
- GlaxoSmithKline GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 < 50% of predicted normal and a baseline post-bronchodilator FEV1/IVC ratio < 70%.
4. 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 hospitalisation) within the 12 months preceding Visit 1.
5. Have stable COPD medication within 4 weeks prior to Visit 1 (no new medication added and no dosage changes in medication).
6. Current or ex-smokers with a smoking history of = 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.
7. Are currently managed at home (outpatients), are ambulatory and able to travel to the clinic. Subjects can be treated with all relevant COPD medication (refer to Section 5.6 of the protocol for details on allowed concomitant medication) including long-acting anticholinergics (Tiotropiumbromide), non-invasive ventilation, long term oxygen therapy and can have Cor Pulmonale.
8. A signed and dated written informed consent is obtained prior to participation
9. Able to comply with the requirements of the protocol and be available for study visits over 52 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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
- Secondary Outcome Measures
Name Time Method