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Ciclesonide Study Demonstrates Significantly Improved Quality-of-Life for Patients With Mild-to-Moderate Asthma
"In addition to conventional indicators of lung function, quality-of-life assessments that provide data on an asthma patient's daily physical, emotional and social difficulties are an important tool for evaluating response to treatment," said Anjuli S. Nayak, MD, Assistant Professor in the Department of Pediatrics at the University of Illinois, College of Medicine, and lead investigator of this study. "Our findings, as seen in this study, demonstrate that Alvesco significantly improves the quality-of-life for patients 12 years and older with mild-to-moderate asthma."
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.
Trial Design and Results
The effect of ciclesonide on quality-of-life was evaluated in an integrated analysis of two identical phase III, 12-week, multicenter, double- blind, randomized, placebo-controlled, parallel-group clinical trials. A total of 1,015 patients with mild-to-moderate asthma (greater than or equal to 12 years; FEV1 60-85% predicted) were randomized to receive placebo or ciclesonide (CIC) 80 MCG (CIC80), 160 MCG (CIC160), or 320 MCG (CIC320) once daily. Quality-of-life was assessed using the overall score from the Juniper Asthma Quality-of-Life Questionnaire (AQLQ) and individual domain scores (activity limitation, symptoms, emotional function and exposure to environmental stimuli) were recorded at baseline and at weeks 4 and 12. A minimally important difference (MID) of greater than or equal to 0.5 was required for each domain or overall AQLQ score to reflect clinically important changes in quality-of-life.
A significant improvement (P
The sanofi-aventis Group and Altana signed an agreement in 2001 to jointly develop and market Alvesco in the United States. The most frequently reported adverse events seen in Alvesco US clinical trials were nasopharyngitis, headache and upper respiratory tract infection.
Asthma is a chronic disease of the lungs and airways. It is characterized by wheezing, coughing and a tightening of the airways, which causes shortness of breath and can be life-threatening. According to the Centers for Disease Control and Prevention (CDC), more than 20 million Americans report having asthma.
Source: sanofi-aventis Group