Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study
Annals of Allergy, Asthma & Immunology, ISSN: 1081-1206, Vol: 122, Issue: 2, Page: 160-166.e1
2019
- 47Citations
- 77Captures
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Metrics Details
- Citations47
- Citation Indexes44
- 44
- CrossRef27
- Policy Citations2
- Policy Citation2
- Patent Family Citations1
- Patent Families1
- Captures77
- Readers77
- 77
Article Description
GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic rhinitis (SAR) treatment. To evaluate the efficacy and safety of once-daily or twice-daily GSP301 in a ragweed pollen environmental exposure chamber. In this randomized, double-blind, double-dummy study, adults (18-65 years old) with SAR were equally randomized to 665 μg of olopatadine and 25 μg of mometasone (twice-daily GSP301), 665 μg of olopatadine and 50 μg of mometasone (once-daily GSP301), a US Food and Drug Administration–approved formulation of 137 μg of azelastine and 50 μg of fluticasone twice-daily (AzeFlu), a US Food and Drug Administration–approved formulation of 665 μg of olopatadine twice-daily, or placebo (twice-daily). During 2 visits (baseline and end of 14-day treatment), participants assessed SAR symptoms at specified time points. The primary end point—mean change from baseline in instantaneous total nasal symptom score (iTNSS) for twice-daily or once-daily GSP301 vs placebo—was analyzed by analysis of covariance. Onset of action, ocular symptoms, and adverse events were assessed. A total of 180 participants were randomized. Treatment with twice-daily or once-daily GSP301 provided statistically significant improvements in iTNSS vs placebo (twice-daily GSP301: least squares mean difference, −3.60; 95% confidence interval [CI], −4.89 to −2.30; once-daily GSP301: least squares mean difference, −3.05; 95% CI, −4.35 to −1.76; P <.0001 for both). Significant improvements in iTNSS with twice-daily GSP301 occurred by 10 minutes after dosing (−1.26; 95% CI, −2.30 to −0.21; P = .02) and were maintained at all later time points except one (2.5 hours). Treatment-emergent adverse events occurred in 22.2%, 30.6%, 25.0%, 22.2%, and 16.7% of participants in the twice-daily GSP301, once-daily GSP301, AzeFlu, olopatadine, and placebo groups, respectively. In an environmental exposure chamber model, twice-daily and once-daily GSP301 treatments were well tolerated and provided statistically significant and clinically meaningful SAR symptom improvement vs placebo. ClinicalTrials.gov Identifier: NCT03444506
Bibliographic Details
http://www.sciencedirect.com/science/article/pii/S1081120618313085; http://dx.doi.org/10.1016/j.anai.2018.10.011; http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85057419917&origin=inward; http://www.ncbi.nlm.nih.gov/pubmed/30321655; https://clinicaltrials.gov/ct2/show/NCT03444506; https://linkinghub.elsevier.com/retrieve/pii/S1081120618313085; https://dx.doi.org/10.1016/j.anai.2018.10.011
Elsevier BV
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