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 | 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 demonstrate that CHF 1535 NEXT DPI® (beclomethasone dipropionate + formoterol fumarate 100/6 μg), 1 inhalation twice daily, is non-inferior to the corresponding dose of CHF 1535 pMDI in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF) in asthmatic adult patients ≥ 18 years under treatment with fixed dose combination of Foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 μg) 1 inhalation bid. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the superiority of CHF 1535 100/6 µg NEXT DPI®, 1 inhalation twice daily, over marketed beclomethasone DPI 100 µg, 1 inhalation twice daily, in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF).
To evaluate the effect of CHF 1535 100/6 µg NEXT DPI® on other lung function parameters and on clinical outcome measures, and the safety and tolerability.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and female adults (≥18 years old). 2. Written informed consent obtained by the patient prior to any study-related procedures. 3. Diagnosis of asthma as defined in the GINA guidelines, update 2009 at least in the 6 months before the screening visit. 4. A documented positive response to the reversibility test (within the last 6 months) defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI (ATS/ERS taskforce 2005). In case the patient doesn’t have any documented reversibility test, this test will be performed at the screening. 5. Patients with a forced expiratory volume in one second (FEV1) > 80% of the predicted values following adequate wash-out from bronchodilators. 6. Asthma Control Questionnaire (ACQ) score < 1.25. This will be confirmed at V3. 7. Asthmatic patients already treated with medium daily dose of ICS (e.g. BDP or equivalent ≤ 1000 µg/die) or low dose of ICS/LABA fixed combination (e.g. salmeterol/fluticasone 100/500 µg/die). 8. Non- or ex-smokers who smoked less than 5 pack-years and stopped smoking for at least 1 year. (Pack/year: number of cigarette smoked per day multiplied by the number of years of smoking/20). 9. Ability to a proper use of pMDI and DPI devices and electronic peak flow meter. 10. A cooperative attitude to be compliant with study procedures. 11. Presence of at least 7 available pre-dose morning PEF measurements in the last 14 days of the run-in period.
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E.4 | Principal exclusion criteria |
1. Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with already documented serum FSH levels > 40 mIU/mL 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) c. double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) A urinary pregnancy test will be performed at screening and at the last visit in women of childbearing potential. 2. Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer. 3. History of near fatal asthma (e.g. brittle asthma, hospitalization for asthma exacerbation in Intensive Care Unit). 4. Diagnosis of COPD as defined by the current GOLD guidelines, updates 2009. 5. Hospitalization due to asthma exacerbation within 1 month prior to the screening visit or moderate/severe asthma exacerbation during the run-in period. 6. Lower respiratory tract infection within 1 month prior to the screening visit. 7. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency. 8. Diagnosis of restrictive lung disease. 9. Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids). 10. Intolerance or contra-indication to treatment with 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments. 11. Having received an investigational drug within 1 month before the screening visit. 12. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion. 13. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to the entire treatment period in average pre-dose morning PEF |
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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 | 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 | 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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 110 |
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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Last Visit of Last Subject |
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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 | 10 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |