Fran Lowry

November 11, 2012

ANAHEIM, California — A new dry form of nasal spray, recently approved to treat allergic rhinitis in adolescents and adults, is also safe and effective for the treatment of seasonal allergic rhinitis (SAR) in children, according to phase 3 data presented here at a poster session at the American College of Allergy, Asthma & Immunology (ACAAI) 2012 Annual Scientific Meeting.

Dr. William Storms

A hydrofluoroalkane-propelled nasal aerosol formulation of beclomethasone dipropionate (BDP; QNASL Nasal Aerosol, Teva Pharmaceutical Industries Ltd) was approved earlier in 2012 in adults, and the next step was to study the product in a pediatric population, lead author William W. Storms, MD, clinical professor at the University of Colorado Health Sciences Center and a practicing allergist in Colorado Springs, told Medscape Medical News.

"The new spray is not as messy as the 'wet' nasal sprays," Dr. Storms said. "This is a metered-dose, pressurized nasal spray rather than a wet pump spray, so not only is it safe and effective in kids, personally, I think it's easier to deliver the product.

"I don't know if you've ever tried to squirt a wet nasal aerosol into kids' noses, but it doesn't work. My patients don't take it, they don't want to take it, but when I told them that there's something else on the horizon and I showed them the adult spray, they said they would take that," he said.

The current study included 715 children with at least a 2-year history of SAR between the ages of 6 and 11 years; it evaluated the efficacy and safety of 2 doses of BDP nasal aerosol, 80 µg or 160 µg, compared with placebo.

The product or placebo was delivered as a single spray once each day for 2 weeks.

"You just occlude one side of the nostril and squirt the product in the other side, and you're done," Dr. Storms commented.

Both doses significantly improved morning and evening patient-reported total nasal symptom scores compared with placebo.

The instantaneous symptom score (the amount of sneezing, runny nose, congestion, and itching symptoms that the child was experiencing at the moment) and the reflective symptom score (how many symptoms were experienced during the past 12 hours) were significantly improved compared with placebo (P < .001), Dr. Storms reported.

In addition, when physicians evaluated nasal symptom relief using the physician-assessed total nasal symptom score, their results also showed greater improvement with both doses of BDP nasal aerosol compared with placebo.

As per physicians' evaluations, the mean treatment difference with BDP nasal aerosol vs placebo was -0.96; 95% confidence interval [CI], -1.4 to -0.5; P < .001 with 80 µg; the mean treatment difference was -0.72; 95% CI, -12 to -0.2; P = .004 with 160 µg compared with placebo

"The most important component of the total nasal symptom score is nasal congestion because that is the most common symptom patients with allergic rhinitis have, and it's the one in children I think leads to the most difficulty because when they have nasal congestion, they can have secondary sinusitis, secondary otitis media, and sleep disturbance," he said.

"We know these kids with allergic rhinitis have less good school performance than the kids without allergic rhinitis and kids whose allergic rhinitis is treated. So this is a very interesting, effective, and safe new product for allergic rhinitis in children," Dr. Storms said.

Dr. John Oppenheimer

Commenting on this study for Medscape Medical News, John Oppenheimer, MD, clinical professor of medicine at New Jersey Medical School, Newark, said that alternatives to the current medicines for allergic rhinitis are needed.

"Nasal steroids presently are wet, and some people don't find it helpful, they don't like the sensation of wetness, they don't feel it's getting in deep enough, so we are looking at dry nasal steroids. This study shows that in children, this represents an alternative that we probably will be able to use," Dr. Oppenheimer said.

"At the end of the day, as long as I can get what the patient wants, and get them to use it, that's really important. The adherence rate to nasal steroids is abominably low, so what I would argue is that giving the patient choice may improve adherence. Having an alternative is one step closer to that," he said.

Jay M. Portnoy, MD, professor of pediatrics at the University of Missouri–Kansas City and Mercy Children's Hospital, in Kansas City, agreed that choice is a good thing.

"For years, patients had a choice of liquid and dry nose sprays. The Montreal protocol banning freon ended that. Now, that choice is finally back. So which is better? It is like asking which is better, chocolate or vanilla? Each person will have their preference. That's a good thing."

The study was sponsored by Teva. Dr. Storms reports financial relationships with Teva, Alcon, SRxA, Sunovion, AstraZeneca, Genentech, Merck, and GlaxoSmithKline. Dr. Oppenheimer reports financial relationships with GlaxoSmithKline, Merck, AstraZeneca, Boehringer Ingelheim, MedImmune, and Novartis. Dr. Portnoy has disclosed no relevant financial relationships.

American College of Allergy, Asthma & Immunology (ACAAI) 2012 Annual Scientific Meeting: Abstract P329. Presented November 10, 2012.

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