MULTICENTRE, RANDOMIZED, OPEN-LABEL, TWO-ARM PARALLEL GROUPS, ACTIVE CONTROLLED STUDY DESIGN TO DEMONSTRATE EFFICACY AND TOLERABILITY OF CLODRONATE 200 MG/4 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE EVERY OTHER WEEK VS CLODRONATE 100 MG/3,3ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE ONCE-WEEK IN A 1-YEAR TREATMENT PERIOD OF WOMEN WITH POSTMENOPAUSAL OSTEOPOROSIS To demonstrate that disodium clodronate 200 mg/4 ml solution for i.m. use with 1% lidocaine administered every other week is not-inferior to disodium clodronate 100 mg/3,3 ml for i.m. use with 1% lido...

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In-vivo deposition of formoterol after inhalation of a single dose of Formoterol HFA- MDI (Chiesi), and Foradil P inhalation powder (Novartis) in COPD patients The aim of this study is to assess intrapulmonary deposition of two Formoterol formulations (FORAIR, Foradil P) in patients with COPD.

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A 12-WEEK, MULTICENTER, MULTINATIONAL, RANDOMISED, DOUBLE BLIND, DOUBLE-DUMMY (OPEN LABEL FOR THE SPACER GROUP), 3-ARM PARALLEL GROUP STUDY COMPARING THE EFFICACY AND THE SAFETY OF CHF 1535 HFA pMDI (BDP/FF 100/6 µg per actuation) 2 PUFFS BID VERSUS BDP HFA pMDI (250 µg per actuation) 2 PUFFS BID, IN ADOLESCENT PATIENTS WITH MODERATE TO SEVERE PERSISTENT ASTHMA The primary objective of the study is to demonstrate the clinical superiority in terms of pulmonary function (change from baseline in pre-dose morning PEF) of CHF 1535 versus a corresponding, in terms...

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Pilot, Open-Label, Randomised, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA PMDI using the Aerochamber Plus™ Spacer Device Versus The Volumatic™ Spacer Device Without or With Charcoal Block in Asthmatic Adult Patients To evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroCh...

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Single blind, randomized, crossover, repeated dose, pharmacokinetic and pharmacodynamic interaction study of CHF 4226 HFA and Extra-fine BUD HFA in asthmatic patients - To compare the systemic exposure of the free combination of CHF 4226 HFA and extra-fine BUD HFA pMDI administered once daily for 4 consecutive weeks in comparison with CHF 4226 HFA and extra-fine BU...

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A study to compare the effect of inhaled treatments: the combination of 3 components (beclometasone/formoterol/glycopyrrolate) to a known single treatment (tiotropium) or the double combination of tiotropium (Spiriva) and beclometasone plus formoterol in patients with chronic obstructive pulmonary disease treated for one year To demonstrate the superiority of CHF 5993 pMDI over Tiotropium in terms of moderate and severe COPD exacerbation rate over 52 weeks of treatment.

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A 48-week, multicentre, multinational, randomized, double-blind, 2-arm parallel group study, comparing the efficacy of FOSTER™ for maintenance and reliever versus fixed-dose FOSTER™ for maintenance + salbutamol as reliever in asthmatics ≥18 years of age 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 ...

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A 24-week, multicenter, multinational, randomized, double-blind, triple-dummy, 3-arm parallel group study comparing the efficacy and safety of CHF 1535 200/6 (beclomethasone dipropionate 200 μg plus formoterol 6 μg/actuation), 2 puffs b.i.d., versus beclomethasone diproprionate HFA (250 μg/actuation), 4 puffs b.i.d., versus Seretide® 500/50 (fluticasone 500 μg plus salmeterol 50 μg/actuation), 1 inhalation b.i.d., in patients with severe asthma In symptomatic patients on high-doses ICS (Inhaled Corticosteroid) beclomethasone diproprionate (two puffs b.i.d.), to demonstrate the superiority of CHF 1535 200/6 (two puffs b.i.d.) versus a high do...

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A clinical study to follow the implantation of Holoclar on the cornea in patients with occular burns Ensayo clínico para evaluar la implantación de Holoclar en la córnea de pacientes con quemaduras oculares To demonstrate the efficacy of Holoclar at one year after the first treatment in patients suffering from moderate to severe (at least two corneal quadrants, central corneal involvement resulting in se...

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Clinical study to test that the drug CHF 1535 100/6 (fixed combination of an anti-inflammatory drug and relaxing airways drug) delivered via pressurized inhaler using or not a spacer device is as effective in adolescent population as the licensed free combination of the same substances and compare it with administration in adults To evaluate, in adolescents, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t, after inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) in compar...

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