Date: 2014-12-11
Type of information: Publication of results in a medical journal
phase: 2b-3
Announcement: publication of results in the European Respiratory Journal (ERJ)
Company: Vectura (UK)
Product: VR475
Action
mechanism: VR475 is an investigational drug/device combination product that comprises the inhaled corticosteroid budesonide, delivered using Vectura’s smart inhalation system, the AKITA Jet, incorporating FAVORITE technology. It is used to deliver budesonide more efficiently to the small airways of the lungs compared with conventional nebulisers. The AKITA Jet inhalation system includes a Smart Card technology to program the device with the patient’s optimal breathing pattern. This ensures targeted delivery of the drug to the lungs as well as being able to detect patient’s compliance. FAVORITE (Flow and Volume Regulated Inhalation TEchnology) is a proprietary, smart nebulisation-based technology.
Disease: asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country: Germany, Poland, Ukraine
Trial
details: 199 patients (18-65 years) with OCS-dependent asthma were randomised (2:1:1:1) to 18-week, twice daily, double-blind treatment with AICS (AKITA inhaled corticosteroid)-Bud 1 mg, AICS Bud 0.5 mg, AICS-placebo, or open-label Bud 1 mg administered by conventional nebuliser (CN-Bud). OCS doses were tapered until week 14. The study was conducted in Germany, Poland and Ukraine. (EudraCT number 2009-014640-11).
Latest
news: * On December 11, 2014, Vectura announced the publication in the European Respiratory Journal (ERJ) of a clinical study demonstrating positive results from its Phase IIb/III (Acti-AICS-001) clinical trial investigating the efficacy, safety and tolerability of VR475 in the treatment of oral corticosteroid (OCS)-dependent (GINA Step 5) asthma patients. The study compared the effects of two doses of budesonide delivered by AKITA Jet inhalation system (AICS-BUD 1 mg and AICS-BUD 0.5 mg) with placebo and budesonide delivered by conventional nebuliser (CN-BUD 1 mg). These treatments were added to standard severe asthma therapies for 18 weeks. Main study findings include: · Significantly more patients successfully reducing OCS dose by more than 50% whilst maintaining asthma stability compared with placebo (primary endpoint; AICS-BUD 1 mg 80% vs placebo 63%; p=0.02) · Mean reduction in OCS dose was 7.1 mg for AICS Bud 1 mg and 3.6 mg for placebo; p=0.005 · Improved lung function for both AICS-BUD doses but not placebo or CN-BUD 1 mg (FEV1 improvement from baseline to week 18: AICS-Bud 1 mg (239 mL; p<0.001); AICS-Bud 0.5 mg (126 mL; p=0.01), placebo (93 mL; p=0.36); CN-Bud (137 mL; p=0.18) · Fewer patients experienced asthma exacerbations in the AICS-BUD 1 mg treated group (AICS-BUD 1 mg, 7.5%) compared with placebo (17.5%) and CN-BUD 1 mg group (22.5%) · Significantly fewer days were spent in hospital in relation to total study duration in the AICS-Bud 1 mg arm (5 of 13,152 patient treatment days vs placebo (49 of 6,328 days), p<0.001) All treatments were well tolerated. VR475 resulted in significant and meaningful OCS reduction in OCS-dependent asthma patients while improving pulmonary function and maintaining asthma exacerbation control. (Nebulised budesonide using a novel device in patients with oral steroid-dependent asthma. Claus Vogelmeier, Peter Kardos, Thomas Hofmann3,, Sebastian Canisius, Gerhard Scheuch, Bernhard Muellinger, Karlheinz Nocker, Guenter Menz and Klaus F. Rabe)
