E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Asthma (patients aged 12-65 years) |
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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 | 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 evaluate the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t, after four single inhalations of fixed combination CHF1535 100/6 NEXT DPI® (total dose: BDP 400 μg / FF 24 μg) in comparison with a free combination of BDP DPI and formoterol DPI licensed products in asthmatic adult and adolescent population. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the pharmacokinetic profile of BDP and formoterol and B17MP - To compare the systemic exposure to BDP/B17MP and formoterol - To evaluate lung function parameters, systemic effects (heart rate, plasma glucose, potassium and cortisol) and thus the general safety and tolerability profile of fixed combination CHF1535 100/6 NEXT DPI® in comparison with a free combination of BDP DPI and formoterol DPI licensed products |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and female adolescents (≥ 12 and < 18 years old) and adults (≥18 and ≤ 65 years old); 2. Written informed consent obtained by the patient in case of adult patients and by parents/legal representative and by the minor (according to local regulation) prior to any study-related procedures; 3. Diagnosis of asthma as defined in the GINA guidelines, update 2009 in the 6 months before the screening visit; 4. Patients with stable asthma enough, according to the Investigator’s opinion, to allow a wash-out period from BDP and inhaled corticosteroids other than BDP of 2 and 1 day, respectively, before study treatments; 5. Asthmatic patients already treated with ICS or ICS/long-acting inhaled β2-agonists or using short-acting inhaled β2-agonists as reliever to control asthma symptoms; 6. Patients with a forced expiratory volume in one second (FEV1) > 70% of predicted values (% pred.) after withholding short acting β2-agonist treatment for a minimum of 6 h prior to screening or 24 h in case of long acting β2-agonist; 7. Non- or ex-smokers who smoked less than 5 pack-years and stopped smoking for at least 1 year; 8. Ability to a proper use of DPI devices (NEXT DPI®, Pulvinal® and Aerolizer®); 9. A cooperative attitude to be compliant with study procedures; 10. Body mass index (BMI) ≥18.5 and ≤ 32 kg/m2 |
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E.4 | Principal exclusion criteria |
1. Pregnant or lactating female. Sexually active female not using efficient contraception throughout the entire study period (e.g. oestroprogestatives, condoms, intrauterine devices). A urinary pregnancy test will be performed at screening and treatment visits (mandatory in the adult population and at discretion of the investigator in the adolescent population) in women of childbearing potential; 2. Having received an investigational drug within 1 months before the screening visit (Visit 1); 3. Diagnosis of COPD as defined by the current GOLD guidelines, update 2009; 4. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, that may interfere with patient’s safety, compliance, or study evaluations, according to the Investigator’s opinion; 5. Known hypersensitivity to the active treatments; 6. History of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units alcohol; one unit being a glass of beer, wine or a measure of spirits), or excessive consumption of xanthine containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc) or psychological or other emotional problems likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements; 7. Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening; 8. Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit; 9. Inability to perform the required breathing technique and blood sampling; 10. Lower respiratory tract infection within 1 month prior to the screening visit; 11. Blood donation (450 mL or more) (for the adult population) or significant blood loss in the 12 weeks before the screening visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | 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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
two cohorts of adolescent and adult patients |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | 4 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |