In:
The Journal of Immunology, The American Association of Immunologists, Vol. 204, No. 1_Supplement ( 2020-05-01), p. 65.28-65.28
Abstract:
Purpose of this DBPC study was to evaluate onset of action and non-inferiority of a novel low dose aqueous solution of Budesonide (“Budesolv 10μg”) to Rhinocort® aqua 64μg (RA) in adult grass pollen allergic patients. Methods Budesonide, a poorly water-soluble corticosteroid, currently marketed as suspension, was reformulated to enhance solubility and local concentration on the target mucosa. Subjects received Budesolv, the market comparator RA and placebo once daily for 8 days. Allergic symptoms were induced by 6h grass pollen challenges in the Vienna Challenge Chamber at days 1 and 8 of each treatment period. First dose was applied after 1:45h to evaluate onset of action of either treatment. Nasal, ocular, asthma symptoms and objective measures of nasal secretion and nasal obstruction were evaluated. A 95% confidence interval (CI) was calculated for difference in means between active treatments. Non-inferiority was stated if the upper limit of the CI did not exceed 115% of the reference. Onset of action was defined as first time point when the difference in nasal symptoms change from baseline between active treatment and placebo was p & lt;0.05. Results 75 patients concluded the study per protocol. The primary endpoint (TNSS; sum of obstruction, itch, sneeze and rhinorrhoea) was met proving non-inferiority of Budesolv compared to RA. A significant difference between Budesolv and placebo was shown for TNSS 2.45 h and for total asthma score 2 h after first dose. On day 8 Budesolv 10μg was significantly better than placebo for all parameters evaluated. Conclusion Non-inferiority of Budesolv compared to Rhinocort® was shown on day 8 of treatment. Early onset of action within 3h after first dose was evident for Budesolv only.
Type of Medium:
Online Resource
ISSN:
0022-1767
,
1550-6606
DOI:
10.4049/jimmunol.204.Supp.65.28
Language:
English
Publisher:
The American Association of Immunologists
Publication Date:
2020
detail.hit.zdb_id:
1475085-5
