Activaero has reported the positive results from its phase II trial in children with mild to moderate asthma.
The proof-of-concept trial was conducted with Activaero's drug-device combination consisting of budesonide in liquid formulation and the company's proprietary controlled inhalation system FAVORITE (Flow and Volume Controlled Inhalation Technology).
Conducted with 41 children in Germany, the study assessed the applicability and potential superiority of Activaero's drug-device combination in comparison to liquid budesonide delivered with a conventional, general purpose nebulizer, PARI LC Sprint.
During the study, patients were treated twice daily over 12 weeks with budesonide suspension [0.5mg/mL concentration] administered via Activaero's inhalation system that uses the company's proprietary FAVORITE approach.
The actual budesonide dose applied with the FAVORITE was reduced by 75% in comparison to the conventional JET nebulizer, as the deposition of the active drug into the lungs with Activaero′s approach is much more efficient, according to the company.
Activaero founder and CEO Gerhard Scheuch said that a relatively long treatment time of 20 minutes is required in asthma therapy of young children while the therapeutic effects are often unsatisfactory and that was the problem in the patients who are unable to stay focused during the inhalation process.
"Our therapy approach has shown that with only 25% of the usual dose the drug deposition into the lung is higher, while, at the same time, treatment duration was significantly reduced to only 2 minutes," Scheuch added.
Based on the phase II trial, Activaero plans to modify the inhalation system for optimal pediatric use.
