"Ciclesonide Effective in Mild and Moderate Asthma: Presented at ERS"
By Paula Moyer
MUNICH, GERMANY -- September 13, 2006 -- The inhaled corticosteroid ciclesonide appears to provide benefit to patients with mild to moderate asthma, according to research presented here at the 16[th annual meeting of the European Respiratory Society (ERS).
"We saw a significant improvement in the rate at which patients required rescue salbutamol after 1 week of treatment," said senior investigator Jaideep A. Gogtay, MD, medical director, medical and research division, Cipla Ltd., Mumbai, India, which markets ciclesonide in India.
Speaking on September 5th, Dr. Gogtay added that the most common adverse events were the local, transient effects that are associated with most inhaled corticosteroids, such as cough, itching throat, and hoarseness.
The investigators were interested in ciclesonide because it is activated in the lung after inhalation and rapidly metabolized in the liver after systemic absorption. Therefore, they hoped that it would have fewer adverse effects than are typically associated with inhaled corticosteroids.
In this study, investigators in several centers in India enrolled 103 subjects who had mild to moderate asthma as defined by a forced expiratory volume in one second (FEV1). Subjects were either steroid-naïve or had not received inhaled corticosteroids for 3 weeks prior to participating in the study. Participants received 200 mcg of ciclesonide daily in a metered dose inhale (MDI).
The study was designed as an open-label, non-comparative, multi-center study that included a 1-week run-in period and 6 weeks of active treatment.
Patients were evaluated using pulmonary function tests at baseline and at weeks 1, 3 and week 6, as well as urinary cortisol levels at baseline and at the end of the study. The subjects kept a daily diary to record their symptoms, morning and evening peak flow readings, and use of rescue medication.
During the treatment period, patients had an average increase in FEV1 of 29.6% and an average increase in the peak expiratory flow rate of 25.2 L/min. Their asthma symptoms, use of rescue medication, and peak expiratory flow rate variability also decreased significantly at the end of the study (P < .001), the researchers reported.
The investigators said they find no significant changes in the morning ratio of urinary cortisol to creatinine. The rate of shortness of breath was 7%, and 7% of patients also experienced cough. Rates of headache and itching in the throat or pharyngitis were 6% for each, and 2% experienced hoarseness.
The investigators concluded that the patients with mild to moderate persistent asthma in this study demonstrated good response with good tolerability to ciclesonide at a dose of 200 mcg in an metered-dose inhaler.
[Presentation title: Once Daily Ciclesonide Delivered Via Pmdi Is Effective and Safe for the Treatment of Mild-to-Moderate Persistent Asthma. Abstract P1242]
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