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Low Incidence of Oropharyngeal Side Effects Reported in Ciclesonide Asthma Study

ANAHEIM, Calif., Nov. 7 /PRNewswire-FirstCall/ -- A new study demonstrated that long-term (52-week) treatment with the investigational therapy Alvesco(R) (ciclesonide) had a low incidence of oropharyngeal side effects (oral candidiasis, dysphonia and pharyngitis) in adult and adolescent patients with mild-to-moderate persistent asthma. The study also found that Alvesco had no effect on the HPA-axis function, a major part of the neuroendocrine system that is believed to be a focus of the body's reactions to external stress. The data were presented today at the 2005 American College of Allergy, Asthma and Immunology annual meeting.

Alvesco is an inhaled corticosteroid with novel release and distribution properties. Inhaled corticosteroids, considered to be the foundation of asthma treatment, work by reducing inflammation -- the underlying disease process -- in the lungs and airways. While they are generally accepted as first-line treatment for asthma, their potential for adverse systemic events can be assessed by the degree to which they cause HPA-axis suppression.

"Our findings are important because the study demonstrated that long-term therapy with ciclesonide had a favorable safety and local tolerability profile for patients with asthma," said William Berger, M.D., Southern California Research, Mission Viejo, California.

Trial Design and Results
The long-term safety of ciclesonide (CIC) was assessed in a 52-week, multicenter, open-label, extension safety study of two identical, 12-week, placebo-controlled, double-blind, randomized efficacy, safety and dose- response studies of 1,015 patients. From the original 1,015-patient population, a cohort of 229 patients was screened; 226 patients received CIC and 179 completed the extension safety study. Patients initially received CIC320 micrograms in the morning for two weeks, and at the investigators' discretion, this dosage was then individualized to CIC80, CIC160 or CIC320 micrograms, as needed to maintain asthma control. Adverse event reporting, oropharyngeal examinations, and pulmonary function (forced expiratory volume in 1 second [FEV(1)] were evaluated from baseline to study end. HPA-axis function was assessed at baseline and at six and twelve months at selected centers.

Prior to entry into this study, 84 percent of patients had previously received at least 2 weeks treatment (CIC80, 21.2 percent or 48 patients; CIC160, 23.0 percent or 52 patients; CIC320, 21.7 percent or 49 patients; placebo, 18.1 percent or 41 patients). The remaining 15.9 percent of patients (36 patients) were not involved in the initial 12-week studies (prior treatment unknown), but were re-screened for enrollment in the long-term safety study. The mean daily dose of CIC was 231.5 micrograms; 90 patients (39.8 percent) received the highest CIC dose (320 micrograms once daily) throughout the study.

Study results showed that CIC was well-tolerated over the 52-week trial. Two patients (0.9 percent) had positive cultures for oral candidiasis (thrush) and 11 patients (4.9 percent) reported pharyngitis (sore throat); one case of each was considered possibly related to treatment. Overall, 13 patients (5.8 percent) experienced at least 1 adverse event that was considered possibly related to treatment. There were no clinically relevant changes from baseline to study end in HPA-axis function, as measured by serum cortisol levels following low-dose (1 microgram) cosyntropin stimulation and 24-hour urinary free cortisol levels corrected for creatinine. While the study was not powered to detect statistical changes in FEV(1), a numerical improvement in pulmonary function was maintained throughout the study.

About Alvesco
The sanofi-aventis Group and Altana Pharma signed an agreement in 2001 to jointly develop and market Alvesco in the United States. Alvesco is approved in 32 countries and currently marketed in 11 countries. The most frequently reported adverse events seen in Alvesco U.S. clinical trials were nasopharyngitis, headache and upper respiratory tract infection.

Source: sanofi-aventis Group; ALTANA Pharma AG

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