Vectura to advance asthma inhaler after phase 2 studies show ease of use by young children | Digital Science

unveiled positive results from two 2 evaluating the ability of and toddlers with to use its nebulized , suggesting that its VR647 budesonide system could reduce delivery times and lower steroid doses compared to current treatments.

The Chippenham, U.K.-based company also announced its plans to pursue phase 3 studies for the U.S. market. Vectura’s breath-activated delivery system offers real-time, feedback, guiding the patient through a specific number of slow, deep breaths and notifying them of successful completion of treatment, while logging adherence data in an app.

One trial showed that children ages 2 to 4 were able to easily use Vectura’s VR647 system equipped with a mouthpiece, diverging from the common belief that young children must use a spacer, facemask or other device when taking an asthma medicine.

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The methodology study enrolled 40 children, 1 to 4 years old, to examine their ability to use Vectura’s inhaler to deliver a fixed-dose formulation of the corticosteroid budesonide, as well as the impact of the age of the child on the need for hands-on support from a parent or caregiver.

The study showed 90% of children age 2 and up were able to effectively use the mouthpiece, demonstrating tight control of breathing patterns with no loss of medication, the company said. Vectura is also developing a facemask for children under 2.

“There are very few approved treatment options for children under 5 years of age,” Vectura’s chief medical officer, Gonzalo de Miquel, said in a statement. “This product has the potential to reduce treatment times and the steroid burden for this patient population, without compromising exposure or safety. We look forward to outlining phase 3 plans with the FDA at the end of the year.”

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The second phase 2 study evaluated VR647’s pharmacokinetics in 17 U.S. children between ages 4 and 8 with symptoms suggestive of asthma. Three different budesonide doses were delivered using Vectura’s inhaler—at 5, 10 and 20 breaths—compared to an approved 1-mg dose of AstraZeneca’s Pulmicort Respules delivered by a conventional jet nebulizer.

According to the company, the VR647 system can achieve the same lung deposition in children with a lower delivered dose without compromising exposure, as well as potentially reduce treatment time by 50% or more. Those results will help define dosing regimens for a planned phase 3 program.

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