Fast effectiveness of a solubilized low‐dose budesonide nasal spray in allergic rhinitis

Abstract

Background Budesonide, a poorly water‐soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator. Objective The study (EudraCT:2018‐001324‐19) was designed to assess non‐inferiority of Budesolv compared to Rhinocort® Aqua 64 (RA) and early onset of action. Methods In a three‐way cross‐over double‐blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n = 83 (ITT); n = 75 (PP)). On day 1, participants entered the Vienna Challenge Chamber (VCC) for 6 hours; first treatment took place at 1:45 hours after entry. Participants treated themselves for further 6 days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge. Results Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90 minutes (P < .05) and 15 minutes (P < .05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (P < .05) after application. Conclusions and clinical relevance The novel preservative‐free, aqueous low‐dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.

Strategies to Improve Drug Strength in Nasal Preparations for Brain Delivery of Low Aqueous Solubility Drugs

“…In fact, even when aiming for a local effect, better results can be obtained by solubilizing the drug. Examples include the solubilization of budesonide in nasal formulations by using Captisol ® , a proprietary cyclodextrin derivative (sulfobutylether-β-cyclodextrin), or Budesolv, developed using Marinosolv ® , a proprietary solubilizing technology platform based on plant derived saponins which form a micellar solution [ 9 , 10 ].…”

Biomarkers of airway inflammation and immunotherapy

“…Allergic Rhinitis (AR) is a major cause of morbidity and affects more than 20% of the population in the United Kingdom and western countries. 8 Intralymphatic immunotherapy (ILIT) was investigated as an alternative allergen immunotherapy method to overcome the limitations of subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). In order to evaluate the safety and efficacy of ILIT, Ahlbeck et al conducted a study of ILIT using birch, grass pollen or both allergens in a 3-year double-blind randomized trial with 72 severe AR patients.…”

“…Allergic Rhinitis (AR) is a major cause of morbidity and affects more than 20% of the population in the United Kingdom and western countries 8 . Intralymphatic immunotherapy (ILIT) was investigated as an alternative allergen immunotherapy method to overcome the limitations of subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT).…”

Developments in the field of allergy in 2020 through the eyes of Clinical and Experimental Allergy

“…A new tool for assessing quality of life called RAPP was developed and shows promise for combining quality of life assessment for asthma and rhinitis 21 . Intervention trials included a new form of nasal steroid and a new form of grass pollen immunotherapy 22‐24 …”

“…21 Intervention trials included a new form of nasal steroid and a new form of grass pollen immunotherapy. [22][23][24]…”