BALTIMORE — The two-drug nasal spray improved sleep in people with moderate-to-severe seasonal hypersensitive rhinitis, a researcher said right here.
In a randomized, placebo-controlled, double-blind trial, the combination of azelastine hydrochloride and fluticasone propionate (Dymista) significantly improved all individual nasal symptoms, according to Daniel Soteres, MD, of Allergy and Asthma Associated in Colorado springs municipal airport, Colo.
At the same time, the spray significantly improved all facets of quality of life, including better sleep, Soteres reported at the annual meeting from the American College of Allergy, Asthma, and Immunology.
The combination, approved in 2102, has been demonstrated to be effective in relieving the symptoms of seasonal allergy, Soteres noted, in contrast to placebo and each of the component medications alone.
People with in season allergic rhinitis are more likely compared to others to report poor sleep, Soteres said, and the investigators hypothesized that improvement in nasal symptoms would correlate with better sleep.
For this analysis, he presented data on a secondary efficacy endpoint — changes from baseline, compared with placebo, in individual nasal symptoms and the rhinoconjunctivitis quality of life questionnaire (RQLQ).
All informed, 207 patients received the medication spray and 210 received a placebo spray during the 2-week demo.
On average, the enhancement from baseline in nasal blockage (based on the reflective total nasal symptom score) was 1 . twenty two points (24%) with the drugs plus 0. 67 points (12. 2%) with placebo, a difference that was substantial ( P < 0. 001), he reported.
On the overall RQLQ rating, where lower scores are much better, patients getting the two-drug spray signed up a drop of 1. 64 points, compared with a drop of zero. 85 points for those on placebo.
The difference was substantial ( P < 0. 001) and met the criterion for a clinically important a result of a minimum 0. 5 unit drop.
On the sleep area of the RQLQ, the changes had been similar — a decline of just one. 62 points with MP29-02 along with a drop of 0. 87 with placebo, which again was substantial ( P < 0. 001).
Modifications in nasal congestion were considerably correlated ( P < 0. 01, r=0. 48) with changes in sleep, Soteres reported.
Nasal blockage in rhinitis has “long already been associated with sleep disorders, ” commented Lyndon Mansfield, MD, of Allergy Companions in El Paso, Tex., who was not involved in the study but who have moderated the session at which it was presented.
“If you improve the nasal congestion — a possibility a function of this particular medication — then people sleep much better, ” he told MedPage Today .
That has a range of knock-on effects, Mansfield said, including less daytime drowsiness and better cognitive performance.
The study had assistance from Meda Pharmaceuticals.
Soteres reported financial links with Meda Pharmaceuticals, Teva, Viropharma, Shire, Hycor, Dyax, Astra Zeneca, plus sanofi-aventis.
Mansfield documented financial links with Genentech, Sunovion, and Teva.
Primary resource: American College of Allergy, Asthma, and Immunology
Source reference: Soteres D, ainsi que al “Improvement in nasal blockage and sleep with MP29-02 within a randomized controlled trial in in season allergic rhinitis” ACAAI 2013; Abstract sixteen.
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