E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 assess therapeutic equivalence of a new generic 12ug dry powder formoterol formulation compared to a reference formoterol formulation. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the safety and tolerability of the new generic 12ug dry powder formoterol formulation. 2. To evaluate the duration of action of the new generic 12ug dry powder formoterol formulation defined as an increase of at least 15 L/min in mean morning PEFR during treatment compared to the mean morning PEFR measured during the baseline period.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
At study entry: 1. Subject has given written informed consent. 2. Female or male subject from 16 - 65 years of age. 3. Documented history of asthma for at least 6 months at the Screening Visit 4. Concurrent use of a short acting inhaled ß2-agonist for symptom relief and inhaled corticosteroids as maintenance treatment. 5. Have an FEV1 >40% of the predicted normal FEV1 after withholding short-acting inhaled ß-agonists for at least 6 hours and long-acting ß-agonists for 24 hours. 6. Subjects who demonstrate at study entry airway reversibility (increase in FEV1 > 12.00% of the predicted value with a baseline FEV1 > 1.3 L and an increase of at least 0.200 L) 15 minutes following inhalation of 1 dose of 12ug formoterol from Oxis Turbuhaler ® after withholding short-acting inhaled ß-agonists for at least 6 hours and long-acting ß2-agonists for 24 hours. 7. Have a Peak Inspiratory Flow between 30 and 90 L/min inclusive measured with the IN-Check device. 8. Subjects are able to use dry powder inhalers with a satisfactory technique. 9. Subjects are able to use the peak flow meter correctly and can produce reliable PEFR readings. 10. Subjects are able to fill in and maintain a Diary Card. 11. Subjects are able to fill in a Questionnaire related to usability of the inhalers. 12. In the opinion of the investigator, subjects understand the trial procedures and are willing to complete the diary card.
At start of treatment: 1. Subjects with an FEV1 of at least 40% predicted normal value for age, height and gender after withholding short acting ß2-agonists for 6 hours and long acting ß2-agonists for the duration of the baseline period.. 2. Subjects who demonstrate airway reversibility (increase in FEV1 >12.00% of the predicted value with a baseline FEV1 > 1.3 L and an increase of at least 0.200 L) 15 minutes following inhalation of the first doses of study medication after withholding short-acting inhaled ß2-agonists for at least 6 hours and long-acting ß2-agonists for the duration of the baseline period.
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E.4 | Principal exclusion criteria |
At study entry: 1. Patients currently receiving oral corticosteroid therapy or who have received oral corticosteroid therapy in the 3 months prior to the start of this study, or who have received more than three short courses of oral corticosteroid therapy in the last year. 2. Patient currently receiving the following medications: - Anticholinergics - Theophylline and other methylxanthines - Use of Monoamine-Oxidase inhibitors or tricyclic antidepressants. - Use of beta-receptor blocking agents like beta-blocking anti-hypertensive products. - Use of Leukotriene-antagonists, either currently or during the last week preceding the screening visit. - Use of long-acting ß2-agonists during the baseline period. 3. Patients currently receiving therapy for an upper respiratory tract infection or who have received such a therapy in the month prior to the start of the study. 4. Patients who have been hospitalised or received emergency treatment for an exacerbation of asthma in the 3 months prior to the start of the study. 5. Patients with a known or suspected hypersensitivity to formoterol, salbutamol or lactose. 6. Heavy smokers >10 cigarettes per day or ex-smokers who smoked more than 10 pack years. 7. Patients with any of the following concurrent conditions: • Uncontrolled diabetes mellitus • Evidence or history of neoplastic disease other than basal cell carcinoma • Evidence or history of tuberculosis • Evidence or history of significant cardiovascular disease • Respiratory disorders other than asthma or rhinitis • Clinically significant hepatic or renal disease • Evidence or history of alcohol or drug abuse 8. Women who are pregnant or lactating. Women of child bearing potential and who are not taking adequate contraceptive precautions which were started at least 3 months prior to participation in the study. 9. Patients who are unlikely to be compliant, take their medication as directed, complete the diary card or attend scheduled clinic visits as required. 10. Patients currently receiving other investigational medication or who have received investigational medication in the month prior to the start of the study. 11. Patients previously randomised into this study. 12. Employees of Andi-Ventis or CRO responsible for the execution of the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean morning PEFR measured before the morning study drug intake |
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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 | Information not present in EudraCT |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
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
| Information not present in EudraCT |
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
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |