| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 |
| The primary objective of the study is to compare the effects of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) on lung function in subjects with COPD during a 2-week treatment period. |
|
| E.2.2 | Secondary objectives of the trial |
| Secondary objectives are to compare the effects of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) on further lung function endpoints at trough and post-dose timepoints using plethysmography, impulse oscillometry and spirometry plus measures of symptomatic benefit and drug safety. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
1. Male or female aged 40 - 80 years inclusive
2. Has an established clinical history of COPD (defined as per the GOLD definition 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. A signed and dated written informed consent is obtained from the subject prior to study participation
4. The subject has a post-bronchodilator FEV1 of >30% to 75% of predicted normal at Visit 1
5. The subject has a post-bronchodilator FEV1 / FVC ratio ≤ 70% at Visit 1
6. The subject achieves a score of 2 on the Modified Medical Research Council (MRC) Dyspnoea Scale at Visit 1
7. The subject is a current or ex-smoker with a smoking history of > 10 pack-years (10 pack years is defined as 20 cigarettes per day for 10 years, or 10 cigarettes (or equivalent if subject smoked cigars or a pipe) per day for 20 years). Ex smokers are required to have stopped smoking for at least 6 months prior to visit 1. Ex-smokers who stopped smoking less than 6 months ago will be defined as current smokers.
8. A female is eligible to enter this study if she is:
a of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal), or
b of child-bearing potential, but has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study
c not a nursing mother
|
|
| E.4 | Principal exclusion criteria |
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1. Has had a COPD exacerbation within the 4 weeks prior to Visit 1 (See Section 6.3.1)
2. Had any changes in COPD medication in the 4 weeks prior to Visit 1
3. Has a current medical diagnosis of asthma and/or allergic rhinitis
4. Has a medical diagnosis of narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction that in the opinion of the investigator should prevent them from entering the study
Note: As with other anticholinergic drugs, subjects with narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction should only be entered into the study at the Investigator’s discretion
5. Has known respiratory disorders other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis)
6. Has undergone lung surgery e.g., lung transplant and/or lung volume reduction
7. Is currently receiving pulmonary rehabilitation
8. 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 3 months of Visit 1)
9. Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as 12 hours oxygen use per day)
10. Requires regular treatment with oral, parenteral, or depot corticosteroids or has received 2 or more periods of oral corticosteroids for COPD exacerbation in the last 6 months
11. Received oral, parenteral, or depot corticosteroids in the 4 weeks prior to Visit 1
12. Received antibiotic therapy for either a lower respiratory tract infection or for COPD exacerbation within the 8 weeks prior to Visit 1
13. Has been hospitalised for a COPD exacerbation in the last year
14. Receiving -blockers (except eye drops)
15. Has serious, uncontrolled disease likely to interfere with the study (e.g. Left Ventricular failure, anaemia, renal or hepatic disease or serious psychological disorders)
16. Received any other investigational drugs within 4 weeks (or 5 half lives) prior to Visit 1
17. Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse
18. Has a known or suspected hypersensitivity to β2-agonists, inhaled steroids, anticholinergic treatments or any components of the formulations (e.g. lactose or milk protein)
19. Has previously been enrolled to this study
20. Subjects who are not considered able to tolerate three 2-weeks wash-out periods according to the study schedule with all COPD medications removed apart from rescue use of VENTOLIN via MDI or DISKUS (inhaled PRN use).
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
• AUC(0-4hr) sGaw (1/kPa*s) after the morning dose of study medication at Day 14
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| 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 | No |
| E.8.1.6 | Cross over | Yes |
| 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 | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| 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 | 0 |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
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