E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | LLT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
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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 compare the efficacy of FOSTER 100/6 µg, one inhalation bid as maintenance therapy plus additional inhalations as reliever [MART approach], with FOSTER 100/6 µg, (one inhalation bid as maintenance therapy) plus salbutamol (100 µg/inhalation) as reliever in not fully controlled asthmatics |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of the therapy on lung function parameters, on other clinical outcome measures, and to assess the safety and the tolerability of FOSTERTM as both maintainance and reliever therapy |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written signed and dated informed consent obtained. 2. Male or female patients aged ≥ 18 years. 3. Clinical diagnosis of asthma for ≥ 6 months. 4. A positive reversibility test, defined as an increase of at least 12% and at least 200 mL from pre-dose in FEV1 30 minutes following 4 puffs (4 × 100 μg) of inhaled salbutamol pMDI. In case this can not be achieved, a documented reversibility test to salbutamol within the last 6 months is acceptable for eligibility. 5. Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month), defined as deterioration in asthma resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for ≥ 3 days because of asthma. 6. Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting beta2 agonists (LABA) at a constant dose (changes in doses for less than seven days are accepted) for two months before V1. In case patients are under ICS only, the daily dose must be ≥ non-extrafine 1000 µg BDP or equivalent. In case patients are under ICS + LABA, the ICS daily dose must be ≥ non-extrafine 500 µg BDP or equivalent. LABA should be stopped at least 24h before V1. 7. Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007)(apart of asthma exsacerbation criteria) in the last month before V1. 8. Forced expiratory volume in the first second (FEV1) ≥ 60% of predicted for the patient normal value. 9. Non smokers or ex-smokers (defined as those who stopped smoking for more than one year and with a smoking history less than 10 pack/year). 10. A co-operative attitude and ability to be trained to correctly use the pMDI. 11. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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E.4 | Principal exclusion criteria |
1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (> 5 mIU/mL). Woman of child-bearing potential unless using an acceptable method of contraception 2. Body Mass Index (BMI) > 34 kg/m2. 3. Patient with lower respiratory tract infections affecting the patient’s asthma within 30 days of the screening visit. 4. Use of systemic steroids in the last month. 5. Patients with other lung diseases such as (but not limited to) COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder. 6. Patients who have an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study. 7. History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias. 8. Cancer or any other chronic disease with poor prognosis (less of 2 years) and /or affecting patient status. 9. Clinically relevant laboratory abnormalities such as (but not limited to) hypokaliemia (<3.5 mEq/L), that might compromise patient’s safety or compliance, interfere with evaluation, or preclude completion of the study, in the judgment of the investigator. Patients with uncontrolled diabetes including patients with a history of plasma glucose levels consistently out of the normal range (> 140 mg /dl) or HbA1C > 8.0%. 10. Patients who have an abnormal QTcF interval value in the screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females). 11. Intolerance or contra-indication to treatment with b2-agonists and/or ICS or allergy to any component of the study treatments. 12. Patients treated with slow-release corticosteroids in the 3 months prior to screening visit 13. Patients unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments. 14. Patients being treated with anti-IgE antibodies. 15. Patients treated with LABA or ICS/LABA fixed combination in the 24h before Visit 1. 16. Patient having received an investigational drug within 2 months before the screening visit. 17. Inability to comply to study procedures or to study treatment intake. 18. Inability to carry out a valid spirometry. 19. Severe asthma exacerbation in the last month before screening visit. 20. Severe asthma exacerbation during the run-in period.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first severe asthma exacerbation. Severe exacerbations will be defined as deterioration in asthma resulting in hospitalisation or emergency room treatment due to asthma worsening, or the need for systemic steroids for ≥ 3 days because of asthma. |
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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) | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 160 |
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 | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |