E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Study is to be conducted in patients with COPD whose airflow limitation, in terms of percentage of predicted FEV1 is between 50-80% normal. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 <80% and > 50% of predicted normal at Visit 1 5. Demonstrates a post-bronchodilator FEV1 / FVC ratio < 70% at Visit 1 6. Has poor reversibility of airflow obstruction defined as < 10% of the predicted normal FEV1 value recorded 30 minutes after inhalation of 400mcg VENTOLIN (FEV1 values of 10.1 to 10.4% will be rounded down to 10%; values of 10.5 to 10.9% will be rounded up to 11%). This must be demonstrated at Visit 1 7. Is a current or former smoker with a smoking history of > 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.
|
|
E.4 | Principal 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 β2-agonists, inhaled steroids or any components of the formulations (e.g. lactose or milk protein)
|
|
E.5 End points |
E.5.1 | 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
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |