Jim Kling

December 09, 2011

December 9, 2011 (Cancun, Mexico) — In patients with mild to moderate persistent asthma, switching from low-dose fluticasone propionate/salmeterol (FP/SAL) to inhaled ciclesonide, 80 µg twice daily, maintained lung function and asthma control, according to a study presented here at the World Allergy Organization XXII World Allergy Conference (WAC).

"Ciclesonide is the most recently available inhaled corticosteroid, and when you're the last person in the market you'd like to find out if you compare favorably with the ones that came before. There are also a fair number of people on treatments that may not be necessary, or may be problematic for that patient. So we were looking to see if…those patients could continue doing well if they were 'stepped down' to ciclesonide," Eli Meltzer, MD, clinical professor of pediatrics at the University of California at San Diego, who presented the research, told Medscape Medical News.

The researchers conducted a post hoc analysis of data from a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study. Members of the subpopulation examined were at least 12 years of age, had mild to moderate persistent asthma, and were receiving low-dose FP/SAL (≤200 µg/100 µg daily via metered-dose inhaler).

Patients received ciclesonide, 80 µg twice daily (n = 58), or placebo (n = 61) for 12 weeks. The researchers tracked changes in forced expiratory volume in 1 second (FEV1) from baseline to week 12, as well as asthma symptom scores, nighttime awakenings (number/day), and use of rescue albuterol (puffs/day).

Among patients treated with ciclesonide, FEV1 increased on average 0.06 L from baseline to week 12, whereas it decreased in patients receiving placebo (change, -0.12 L; P =.006). The researchers also saw non–clinically significant improvements in nighttime awakenings from baseline to week 12 (ciclesonide 80 µg, 0.01; placebo, 015; P = .0148). Similar reductions were seen in rescue albuterol use (ciclesonide 80 µg twice daily, 0.09; placebo, 0.74; P = .0108) and total asthma symptom score (ciclesonide 80 µg twice daily, -0.11; placebo, 0.42; P = .004).

"It showed that patients could go from combination therapy to replacement inhaled steroid therapy, to a monotherapy alone, and this has been a direction that's been propagated by the [Food and Drug Administration], which wants to limit use of long-acting beta-agonists. The data that was provided was reassuring that that switch could take place fairly safely," Stanley Szefler, MD, head of pediatric clinical pharmacology at National Jewish Health, Denver, Colorado, who co-moderated the session, told Medscape Medical News.

The study was funded by Sunovion Pharmaceuticals. Dr. Meltzer is a paid consultant to the company. Dr. Szefler is the head of the pediatric steering committee for Glaxo.

World Allergy Organization XXII World Allergy Conference (WAC): Abstract 3192. Presented December 6, 2011.


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