E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with moderate Chronic Obstructive Pulmonary Disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038738 |
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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 |
Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose, compared with salmeterol, 50 μg single dose, in patients with moderate COPD. Primary efficacy variable � Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes post dose. Secondary efficacy variables � Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes) � Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes) � Proportion of patients who has achieved at least 12% increase in FEV1 at 5 minutes post dose. � Proportion (cumulative) of patients who has achieved at least 12 % increase in FEV1 at each time point between 10 to 120 minutes post dose. � Time to a 12 % increase in FEV1 |
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E.2.2 | Secondary objectives of the trial |
Evaluate safety: � Adverse events (nature, incidence and intensity) � Pulse rate and blood pressure |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For inclusion in the study patient should fulfil the following criteria: 1. Provision of informed consent obtained prior to conducting any study-related procedures including withdrawal of pre-study medication 2. Outpatients, female or male, ≥ 40 years 3. A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms 4. A current or previous smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year). 5. Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication. 6. FEV1/FVC < 70 %, post-bronchodilator 7. Postbronchodilatory FEV1 in the range ≥ 50 to ≤ 80 % of predicted normal value. |
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E.4 | Principal exclusion criteria |
Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. A history and/or current diagnosis of asthma. 2. A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40. 3. A known total blood eosinophil count over 400 mm3. 4. Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period. 5. Patients who have been treated with depot parenteral glucocorticosteroids ≤ 12 weeks prior to Visit 1 6. Patients who have been treated with oral, parenteral or rectal glucocorticosteroids ≤ 30 days prior to Visit 1 7. Patients who have been treated with leukotriene antagonists or 5-lipoxygenase inhibitors ≤ 1 year prior to Visit 1 8. Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator. 9. Any current respiratory tract disorder other than COPD, including respiratory diseases described in GOLD guidelines as needed to be differentiated from COPD, which is considered by the investigator to be clinically significant. 10. Any significant disease or disorder 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. 11. Any clinically relevant abnormal finding in physical examination or vital signs, at Visit 2 which, in the opinion of the investigator, may put the patient at risk because of participation in the study. 12. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator. 13. Known or suspected hypersensitivity to study therapy and/or excipients. 14. Scheduled in-patient hospitalisation during the course of the study. 15. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance. 16. Patients participating in or scheduled for an intensive COPD rehabilitation program. 17. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at study site. 18. Previous enrolment (that failed due to inclusion/exclusion criteria and/or safety) or randomisation of treatment in the present study. 19. Participation in another clinical study evaluating an investigational drug in the last 8 weeks prior to Visit 2 or during this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy variable: � Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes post dose. |
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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 | No |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 | No |
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
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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 | 8 |
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 | 8 |