E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COPD (Chronic Obstructive Pulmonary Disease) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
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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 |
To demonstrate the superiority of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (AUC0-30min standardized by time of change from pre-dose in FEV1) after drug inhalation in the morning of day 1, and the equivalence between Foster® 100/6 (two puffs b.i.d.) and Seretide® 500/50 (one inhalation b.i.d.) in terms of Transition Dyspnoea Index (TDI) score at day 84 in patients with Chronic Obstructive Pulmonary Disease. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of the test treatments in terms of additional spirometric parameters and of clinical outcome measures, to assess the safety and tolerability, and to perform an exploratory analysis evaluating the consumption of resources deriving from COPD management in the perspective of the Healthcare System. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative. 2. Outpatients with a clinical diagnosis of moderate to severe COPD and including: a) Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) x (number of years of smoking)] / 20, both current and ex-smokers are eligible. b) Regular use of bronchodilators (e.g. β2-agonist, anticholinergics) in the 2 months before visit 1. c) Post-bronchodilator FEV1 < 60% of the predicted normal value at visit 1. d) Post-bronchodilator FEV1/FVC < 0.7 at visit 1. e) An increase in FEV1 ≥ 5% from baseline following administration of 400 µg of salbutamol at visit 1. f) A Baseline Dyspnoea Index (BDI) focal score < or = 10 (at visit 1 and at visit 2). 3. History of no more than one COPD exacerbation in the previous 12 months (without considering the last 2 months) to visit 1. COPD exacerbation will be defined according to the following: “A sustained worsening of the patient’s condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids (at least 3 days) and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization”. 4. A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Accuhaler®, circular moulded plastic inhaler) inhalers.
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E.4 | Principal exclusion criteria |
1. Diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator’s opinion. 2. Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or are using one or more of the following acceptable methods of contraception: a) surgical sterilization (e.g. bilateral tubal ligation, hysterectomy); b) hormonal contraception (implantable, patch, oral, injectable); c) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository. d) Continuous abstinence (e.g. nuns). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation. 3. Clinical or functional unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which may impact the evaluation of the results of the study according to investigator’s judgement. 4. Patient with narrow-angle glaucoma. 5. Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which may impact the evaluation of the results of the study and the safety of the patient according to investigator’s judgement. 6. Patients with COPD exacerbation (see previous at inclusion criteria no. 3) in the 2 months prior to screening and during the study period. 7. Patients requiring long term (> 12 hours daily) oxygen therapy for chronic hypoxemia. 8. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period. 9. Patients with known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in the study drugs. 10. Patients who have evidence of alcohol or drug abuse, not compliant with the study protocol or not compliant with the study treatments according to investigator’s judgement. 11. Major surgery in the previous 3 months and during the trial which may affect patient’s compliance in study procedures (e.g. spirometry). 12. Participation in another clinical trial with an investigational drug in the 2 months preceding visit 1. 13. Patients requiring chronic mechanical ventilation for COPD.
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E.5 End points |
E.5.1 | Primary end point(s) |
- AUC0-30min standardized by time of change from pre-dose in FEV1 after drug inhalation in the morning of day 1 (V2); - Transition Dyspnoea Index (TDI) score at day 84 (V5).
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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 | No |
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 | Yes |
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) | 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 |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 79 |
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 |
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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 | 14 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 14 |
E.8.9.2 | In all countries concerned by the trial days | 0 |