New Nasal Spray Sustains 24-h Symptom Relief in Allergic Rhinitis

TORONTO, Canada—A major drawback of existing allergy medications, according to a recent survey of patients with allergies, is that patients feel that they are not particularly effective or that they do not offer complete 24-hour symptom relief, presenters said at the annual meeting of the American Academy of Otolaryngology—Head and Neck Surgery.

The new intranasal spray ciclesonide (Omnaris), which received FDA approval in October, may be able to overcome these shortcomings. Results from 2 phase 3 studies show that ciclesonide improves nasal symptoms in patients with seasonal or perennial allergic rhinitis and that the drug’s effects last for a full 24 hours, observed Paul H. Ratner, MD, medical director, Sylvana Research, San Antonio.

The 2 studies were independent, randomized, double-blind, parallel-group, placebo-controlled, multicenter trials involving adult and adolescent patients (≥12 years) with seasonal allergic rhinitis (n = 327) or perennial allergic rhinitis (n = 471).

Patients were randomized to intranasal ciclesonide 200 μg or to placebo once daily for 28 days (seasonal allergic rhinitis patients) or for 6 weeks (perennial allergic rhinitis patients).

The primary efficacy measure for the seasonal allergic rhinitis study was change from baseline in the average of am and pm patient-reported total nasal symptoms score (a combination of nasal congestion, itching, rhinorrhea, and sneezing) during days 1 to 14.

The primary efficacy measure for the perennial allergic rhinitis study was the average score of am and pm patient-assessed reflective total nasal symptoms during days 1 to 42.

Ciclesonide improved total nasal symptom scores compared with placebo in both studies (P <.001). Improvements were similar in the am and pm symptom scores, suggesting a 24-hour effect.

&#8220;All 4 nasal symptoms that are scored in the total symptom score&#8212;which are rhinorrhea, nasal itching, sneezing, and congestion&#8212;improved individually, as well as the total symptom score,&#8221; Dr Ratner said. &#8220;The adverse events reported were no different with the active group with ciclesonide compared with the placebo patients in both trials.&#8221;

He said, &#8220;There are obviously a bunch of nasal steroids on the market right now, [but] patients with allergic rhinitis feel that the current therapies are not particularly effective or giving them true 24-hour relief, so there&#8217;s a continued impetus to develop better, newer nasal steroid preparations.&#8221;

He added that this preparation &#8220;theoretically at least, has even less absorption into the system than anything that&#8217;s currently out there.&#8221;

Ciclesonide Receives FDA Approval

Ciclesonide nasal spray (Omnaris; Altana AG) 200 μg once daily has been approved as intranasal corticosteroid treatment for nasal symptoms associated with seasonal and perennial allergic rhinitis in patients —12 years and in children ages 2 to 11 years. The most common side effects associated with the drug include headache, nosebleeds, and inflammation of nose and throat linings. www.altana.com