Source: Radiology  |  Posted 4 years ago

By Paula Moyer

SAN DIEGO, CA -- March 2, 2007 -- Intranasal ciclesonide (Alvesco) along with high-dose inhaled fluticasone combined with salmeterol (Advair) 500 mcg does not appear to increase cortisol suppression beyond what is typically seen with high-dose fluticasone.

"Ciclesonide had no additive inhibitory effect when used concomitantly with combined fluticasone-salmeterol," according to principal investigator Kenneth Kim, MD, president and chief executive officer, West Coast Clinical Trials, Long Beach, California, United States. "Therefore, ciclesonide may provide a safe treatment option for patients with allergic rhinitis and asthma who need both an intranasal and an inhaled corticosteroid."

Dr. Kim presented the findings in a presentation here on February 25[^]th[] at the 2007 American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting.

The investigators wanted to assess the safety of concomitant use of an intranasal and an inhaled corticosteroid in patients with perennial allergic rhinitis. The inhaled corticosteroid consisted of fluticasone propionate at a dose of 500 mcg, and the inhaled corticosteroid was salmeterol at a dose of 50 mcg, taken in the conventional manner of twice daily.

After the 150 patients underwent a 10-day run-in period with the fluticasone-salmeterol combination and a placebo nasal spray taken once daily, they were randomised to receive concomitant intranasal ciclesonide 200 mcg or placebo once daily for 43 days. They also received a single 2-mg oral dose of dexamethasone as an active control on the last treatment day.

The investigators obtained 24-hour plasma cortisol levels on the first and last days of the run-in and at the end of treatment.

Plasma cortisol area-under-curve in a 24-hour period (AUC[_]0-24h[]) was lower by an average of 53.7 mcg/dL for the corresponding hour during the fluticasone-salmeterol run-in period compared with baseline ([]P[] < .001). This reduction showed that this dose of fluticasone was associated with measurable suppression.

When ciclesonide was added to the regimen, the average decrease in plasma cortisol AUC[_]0-24h[] was 2.9-mcg/dL greater for matched hours in the group on the intranasal placebo compared with those on the intranasal corticosteroid, a difference that was not statistically significant, according to the investigators.

When patients received the dexamethasone dose, the average plasma cortisol AUC[_]0-24h[] decreased by 73.3 mcg/dL for corresponding hours ([]P[] < .001). This finding showed that further cortisol suppression beyond that seen with fluticasone was possible, and confirmed the finding that ciclesonide did not cause further suppression, the investigators reported.

The study was sponsored by Altana, which manufactures Alvesco. Dr. Kim has no financial ties to the company.

[Presentation title: Coadministration of Intranasal Ciclesonide and Inhaled Fluticasone Propionate-Salmeterol in Perennial Allergic Rhinitis (PAR). Abstract 562]