Study is to be conducted in patients with COPD whose airflow limitation, in terms of percentage of predicted FEV1 is between 50-80% normal.
Conditions
Interventions
Trade Name: Seretide Diskus 50/250 microg/dose
Product Name: Seretide DISKUS (50/250mcg/dose)
Product Code: Seretide DISKUS COPD/001
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Propos
Sponsors
GlaxoSmithKline AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is male or female aged 40 - 80 years inclusive 2. Has an established clinical history of COPD stage II (As per the GOLD definition (GOLD 2003) which defines COPD as characterised by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases) 3. Provides a signed and dated written informed consent form prior to participation 4. Demonstrates a post-bronchodilator FEV1 of 50% of predicted normal at Visit 1 5. Demonstrates a post-bronchodilator FEV1 / FVC ratio 10 pack-years (10 pack years is defined as 20 cigarettes (or equivalent if subject smoked cigars or a pipe) per day for 10 years, or 10 cigarettes per day for 20 years). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Smokers who have stopped smoking less than 6 months before Visit 1 will be defined as current smokers 8. Achieves a minimum score of ? 2 on the Modified Medical Research Council Dyspnoea Scale at Visit 1(See Appendix 3) 9. A female is eligible to enter this study if in addition to the above, she is of: a) non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal), or b) child-bearing potential but has a negative urinary pregnancy test at Visit 1 and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study. Are the trial subjects under 18? 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
Exclusion criteria
Exclusion criteria: 1. Is experiencing an exacerbation of COPD requiring treatment with oral corticosteroids and/or antibiotics or hospitilisation, or has experienced such exacerbation in the 4 weeks prior to Visit 1 2. Has a current medical diagnosis of asthma, eczema, atopic dermatitis and/or allergic rhinitis 3. Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis) 4. Has undergone lung surgery e.g., lung transplant and/or lung volume reduction 5. Had a chest X-ray indicating diagnosis other than COPD that might interfere with the study (chest X-ray to be taken at entry to the run-in period, if subject has not had one taken within the last 3 months) 6. Is a nursing mother 7. Requires regular (daily) or long term oxygen therapy (LTOT). LTOT is defined as ? 12 hours oxygen use per day with resting PO2 below 7.3 8. Is receiving ?-blockers (except eye drops) 9. Has serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study 10. Had any changes in COPD medication in the 4 weeks prior to Visit 1 11. Received antibiotic therapy and/or been hospitalised for a lower respiratory tract infection within the 4 weeks prior to Visit 1 12. Has received tiotropium bromide, inhaled corticosteroids or anti-leukotrienes including modulators of leukotriene production such as Zileuton, montelukast or zafirlukast within 14 days prior to Visit 1 13. Has received oral/parenteral corticosteroids within the 4 weeks prior to Visit 1 14. Has received any other investigational drugs within the 4 weeks prior to Visit 1 15. Has a known or suspected hypersensitivity to ß2-agonists, inhaled steroids or any components of the formulations (e.g. lactose or milk protein)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectiveness of SERETIDE 50/250mcg with salmeterol 50mcg both delivered twice daily via the DISKUS/ACCUHALER inhaler on lung function (Trough FEV1) and relief of dyspnoea as measured by the Transition Dyspnoea Index (TDI) in subjects with COPD over a 24 week treatment period.;Secondary Objective: To assess the effect of treatment on quality of life as determined using the St George’s Respiratory Questionnaire (SGRQ) To compare effects of treatment on other parameters of treatment efficacy including lung function and symptoms of COPD ;Primary end point(s): ? Change from baseline in trough FEV1 (measured prior to use of VENTOLIN and before the administration of the morning dose of study medication) at endpoint. ? Transition Dyspnoea Index (TDI) focal score at endpoint | — |
Countries
Sweden
Outcome results
None listed