Clinical Research

A number of clinical studies continue to investigate new indications for the use of Curosurf^® (poractant alpha), the world leader in the treatment of respiratory distress syndrome in premature infants. These studies are testing the efficacy of Curosurf in three different clinical conditions: Adult Respiratory Distress Syndrome (Balcapulco), single dose use of surfactant in the pre-extubation of pre-term neonates (Pre -Extubation) and finally, the preventive use of Curosurf in theEarly Continuous Positive Airway Pressure (CURPAP).

The completion of the clinical studies on Bramitob^® (nebulised tobramicyn) led to the registration of this compound in twelve European countries for the treatment of cystic fibrosis patients with Pseudomonas
aeruginosa infection.

Three cardiovascular trials completed the product profile of the antihypertensive agent, manidipine and its fixed combination with delapril by defining the efficacy of:
• manidipine in isolated systolic hypertension in the elderly
• fixed combination manidipine – delapril in the hypertensive patient with type 2 diabetes
• fixed combination manidipine – delapril in patients non-responsive to manidipine monotherapy.

Foster^®, the fixed combination of beclometasone dipropionate and formoterol fumarate, indicated for the treatment of moderate and severe persistent asthma, was recently launched in Germany and has been mutually
approved in fifteen European countries. It is now undergoing additional clinical investigation to obtain the additional COPD indication and extend its use to additional patient populations (paediatrics and adolescents).
CHF 4226 (carmoterol) is a new ß2 agonist under clinical development (phase 2) both as a single agent and in a fixed combination with budesonide (CHF 5188) for the indications of asthma and COPD. The fixed combination is highly promising in view of a potential once–a–day administration that would significantly simplify the treatment for patients and improve their quality of life.

Beginning with the idea of reducing global pollution by limiting CFC propellants, Chiesi developed Modulite^®, a proprietary technology platform, which is based on the use of ozone-friendly HFA (hydrofluoroalkane) propellants to prepare pressured metered dose inhalers. In 2006 Modulite^® technology was awarded the Frost & Sullivan Award for Technology Innovation. This technology was used in the successful registration and
launch of BDP Modulite^® in the UK, and the registration and launch of Foster^®. Finally, a new milestone was achieved in inhalation technology with the delivery of a pilot prototype for a new dry powder inhaler device (Next^® DPI). This allowed the completion of preliminary pharmacokinetic and pharmacodynamic investigations with Foster^® DPI. Such investigations mark the beginning of a registration program for the new Foster^® formulation.