Ciclesonide Linked to Quality-of-Life Improvements in Severe Asthma

Paula Moyer, MA

March 22, 2005

March 22, 2005 (San Antonio) — Treatment with the new inhaled corticosteroid ciclesonide (Alvesco) is linked to improved quality of life in patients with severe asthma, according to findings presented here at the 61st annual meeting of the American Academy of Allergy, Asthma & Immunology.

"In this study of quality-of-life outcomes, we found that patients with severe persistent asthma did as well with ciclesonide as with fluticasone and both were superior to placebo," said principal investigator David I. Bernstein, MD. This finding shows that the availability of ciclesonide broadens physicians' treatment options in a difficult-to-treat population, he noted. Dr. Bernstein is a professor of clinical medicine in the division of allergy/immunology at the University of Cincinnati in Ohio.

One of the apparent advantages of ciclesonide is that it may be associated with a low rate of local effects, such as dysphonia and oral candidiasis. Other research presented here showed that ciclesonide was associated with no different rate of hoarseness and oral candidiasis than was placebo, said Dr. Bernstein.

"Physicians need to consider, when they compare different drugs within the same class, the advantages and disadvantages, because inhaled corticosteroids have been shown to be effective," Dr. Bernstein said. "What may differentiate one from the other is safety aspects." Therefore, he urged his colleagues to "keep abreast of safety studies" because so many studies are addressing this issue and the data can change, he said.

To determine whether ciclesonide was linked to an effect on quality of life because of the known inverse relationship between asthma severity and quality of life, the investigators used the Juniper Asthma Quality of Life Questionnaire (AQLQ) examined whether patients' reports on this parameter were influenced by treatment with the study drug.

A total of 531 patients with severe asthma who had been randomized to receive ciclesonide at a dose of 160 or 320 µg twice daily, fluticasone at a dose of 440 µg twice daily, or placebo. The treatments were given in a metered-dose inhaler. Patients were at least 12 years old and had forced expiratory volumes at one second (FEV1) of 40% to 65% of that predicted for the individual's age and height.

The patients had participated in a 12-week, phase 3, multicenter, double-blind, parallel-group, placebo-controlled trial. The investigators recorded patients' overall AQLQ scores and individual domain scores at baseline and at weeks 4 and 12. The domains of interest consisted of activity limitation, symptoms, emotional function, and exposure to environmental stimuli. The study required a minimally important difference (MID) of at least 0.5 for each domain or overall AQLQ score to determine that clinically important changes in quality of life had occurred.

The investigators observed clinically significant improvements in overall AQLQ scores between baseline and week 12 in all of the treatment groups compared with placebo (P < .0001). Patients in the ciclesonide 160 µg twice-daily group had an average increase of 0.61 compared with placebo; those receiving 320 µg twice daily had an average increase of 0.65 compared with placebo. The fluticasone group's score exceeded placebo by an average of 0.91 points.

Of the four individual domain scores, the changes were also significantly greater for all of the treatment groups compared with placebo (P = .004). In the group receiving 160 µg twice daily of ciclesonide, 42.5% had an increase of at least 0.5 in all four groups compared with a rate of 43% for those receiving 320 µg twice daily. The rate for the fluticasone group was 58.8%, and 26.8% of those receiving placebo had such an increase.

"It's known that patients with severe asthma suffer from significant deterioration in quality of life, and it appears that this new inhaled corticosteroid can restore it," said William E. Berger, MD, in an interview seeking outside comment. "The study shows that this new treatment represents a viable treatment option for physicians who care for these patients." Dr. Berger is a clinical professor of medicine in the department of pediatrics in the division of allergy and immunology at the University of California in Irvine.

The study was funded by Aventis and Altana Pharma, who partner in the manufacture and marketing of Alvesco.

AAAAI 61st Annual Meeting: Abstract 836. Presented March 22, 2005.

Reviewed by Gary D. Vogin, MD



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