In the open-label study, September 5^th, 472 patients with moderate asthma received either 320 mcg of ciclesonide once daily or 200 mcg of fluticasone propionate twice daily for 12 weeks. For 1 to 4 weeks prior to the study period, the patients received either a minimum of 250 mcg of fluticasone daily, or an equivalent dose of inhaled corticosteroids, or rescue medication.

For their study, the researchers, led by Louis-Philippe Boulet, MD, head, allergy and asthma clinic, Institute of Cardiology and Pulmonology, Laval University Hospital, Québec City, Canada, defined moderate asthma according to evidence-based guidelines released in 2002 by the Global Initiative for Asthma.

Enrollment criteria included a forced expiratory volume in 1 second (FEV₁) that was at least 80% of predicted value with fluticasone or 60% to 80% of predicted value on rescue medication, as well as other criteria for moderate asthma.

Patients recorded in a diary their daily FEV₁ (spirometry), symptoms, and use of rescue medication. Patients' quality of life was assessed with the Asthma Quality of Life Questionnaire, Standard (AQLQ [S]).

Results show that pre-study FEV₁ levels were high in both treatment groups -- 88% in the ciclesonide group and 90% in the fluticasone group. Improvements in FEV₁ were also comparable between groups, an average of 171 mL in the ciclesonide group and 186 in the fluticasone group (P < .0001 compared to baseline for both groups).

In each group, median percentage of days free of asthma symptoms was 88%. The median percentage of days in which no rescue medication was used was 85% in the ciclesonide group and 84% in the fluticasone group. Rates of exacerbations were similarly low in the 2 groups (ciclesonide 1.29%, fluticasone 2.09%).

The groups had high baseline AQLQ(S) scores; however, the ciclesonide group had an improvement that was significantly greater (0.29 vs 0.11, respectively, P = .0051).

In addition, none of the patients on ciclesonide developed oropharyngeal candidiasis, compared to 3.8% of those on fluticasone (P = .002).

"This study showed that patients get similar benefits with each treatment, but that ciclesonide was associated with a more favorable quality of life," Dr. Boulet said. "Ciclesonide was also less likely to be associated with oropharyngeal candidiasis."

The study was funded by Altana, which manufactures Alvesco.


[Presentation title: Comparison of Ciclesonide (MDI) Once Daily and Fluticasone Propionate (Diskus(R)) Twice Daily in the Treatment of Patients With Moderate Asthma. Abstract P3863]

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