| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| This is an application for a phase III study to be conducted in COPD patients. |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Classification code | 10010952 |
|
| 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 efficacy (pre-/post dose FEV1) of Symbicort® pMDI (pressurised Metered Dose inhaler) 2x 160/4.5μg/inhalation twice daily and of Symbicort® pMDI 2x 80/4.5μg/inhalation twice daily to formoterol Turbuhaler 2x4.5μg/inhalation twice daily and placebo, over a 12-month period in patients with COPD. |
|
| E.2.2 | Secondary objectives of the trial |
| To evaluate efficacy for a number of secondary variables (e.g. dyspnea, QoL, exacerbations) and safety (e.g. AE, ECG, urinary cortisol, ophtalmology, bone mineral density, hematology, clinical chemistry) of budesonide and formoterol. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
1. Signed written informed consent from the patient.
2. Outpatients, men or women >= 40 years of age.
3. Clinical diagnosis of COPD, with COPD symptoms for more than 2 years.
4. Smoking, current or previous, with a smoking history >= 10 pack years.
5. Pre-bronchodilatory FEV1 £50% of predicted normal value.
6. Pre-bronchodilatory FEV1/VC <70 %
7. Documented use of short-acting inhaled bronchodilatator (β2-agonist or anticholinergics) as rescue medication.
8. A score of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months prior to Visit 1 (ie, not within the 30 days prior to Visit 1).
9. Total symptom score of 2 or more per day for at least half of the run-in period (by totalling the Breathlessness Diary, cough and sputum scores from the diary card). |
|
| E.4 | Principal exclusion criteria |
1. A history of asthma (National Institutes of Health 2002).
2. A history allergic rhinitis before 40 years of age.
3. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator.
4. Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant.
5. Known homozygous Alpha-1 antitrypsin deficiency.
6. Any significant disease or disorder (e.g. gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patients ability to participate in the study.
7. Patients who have needed additions or alterations to their usual maintenance or rescue therapy for COPD due to worsening symptoms within the 30 days prior to Visit 1.
8. Use of oral or ophthalmic non-cardio-selective b-blocking agents.
9. Use of oral steroids.
10. Participation in a COPD rehabilitation program within 6 months prior to the study or who are scheduled for such a programme during the study.
11. Known or suspected hypersensitivity to study therapy or excipients.
12. Scheduled in-patient hospitalisation during the course of the study.
13. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator. Female patients who are not post-menopausal or surgically sterile must have a negative pregnancy test prior to randomisation.
14. Participation in a clinical study evaluating an investigational drug in the last 30 days prior to Visit 1, or previous allocation of a randomisation code in this study (if a patient has previously been enrolled, fulfilled all the inclusion criteria and none of the exclusion criteria at Visit 1, but was not eligible to be randomized due to worsening COPD symptoms in the run-in period, the patient may be enrolled into the study a second time).
15. Previous participation in a Symbicort pMDI clinical study.
16. A history of any condition associated with poor compliance.
17. Involvement in the planning or conduct of the study (applies to both AstraZeneca staff and staff at the Investigator site).
18. At Visit 2: patient who have needed additions or alterations to their usual maintenance or rescue therapy for COPD due to worsening symptoms since Visit 1.
19. In the ophthalmologic assessment sub-group: inability to dilate pupil 6mm or more. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Pre-dose FEV1 and 1 hour post-dose FEV1. |
|
| 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 | Yes |
| 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 | Yes |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| 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 | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| 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
|
| Database lock has been defined as the end of the trial to ensure consistency with trials conducted outside the EU. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 11 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 11 |
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