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| |  Ciclesonide Improves Lung Function and Is Safe in Patients With Asthma: Presented at ACAAI By Sandra Ripley Distelhorst SEATTLE, Wash -- November 10, 2008 -- The inhaled corticosteroid (ICS) ciclesonide is effective for the management of asthma in place of other ICS treatments as well as in treatment-naive patients, researchers reported here at the American College of Allergy, Asthma & Immunology (ACAAI) annual conference. Ciclesonide is a novel ICS approved in the United States for patients aged 12 years and older for the long-term treatment of persistent asthma. Previous studies have shown ciclesonide to have a favourable safety profile. Evidence of ciclesonide's safety and efficacy for persistent asthma in patients aged 12 years and older was presented at poster abstract sessions here on November 8. Of 6 ciclesonide studies presented, 3 included only patients with no previous ICS therapy and 3 included only patients who were receiving ICS therapy. Phillip E. Korenblat, MD, Washington University School of Medicine and the Clinical Research Center, St. Louis, Missouri, presented a set of studies that evaluated the effects of ciclesonide treatment on lung function in more than 400 patients aged 12 years and older with stable, mild to moderate persistent asthma who had been treated previously with another ICS. In the first 2 analyses, patients were randomised to receive ciclesonide 80 mcg twice daily (n = 149), ciclesonide 160 mcg once daily in the morning (n = 150), or placebo (n = 147). A second set of studies was presented by Edward Kerwin, MD, Clinical Research Institute of Southern Oregon, Medford, Oregon. These studies were all multicentre, double-blind, placebo-controlled, parallel-group trials that recruited approximately 700 patients aged 12 years and older with a history of 6 months or more of persistent asthma. Subjects in all 3 analyses had a forced expiratory volume at 1 second (FEV1) of 60% to 85% of predicted and uncontrolled asthma demonstrated by symptom scores, albuterol use, and peak expiratory flow measurements. Subjects in the studies from Dr. Kerwin were randomised to ciclesonide 80 mcg twice daily, ciclesonide 160 mcg once daily in the morning, or placebo for 16 weeks or to ciclesonide 80 mcg twice daily for 4 weeks and increased to 160 once daily for 12 weeks. According to Dr. Kerwin, having these 2 parallel sets of studies fits well with the requirements from the US Food and Drug Administration to study new drugs both in patients who have not received similar treatments and in patients who are receiving treatment but may switch to a new drug. Results in all studies showed similar trends across studies for both groups of patients -- those with previous ICS use and those with no ICS use in the previous 6 months. The 3 main study outcomes were as follows: reduced rescue medication, improved lung function (FEV1), and minimal adverse events. All 6 studies considered, the 2 studies that examined the need for rescue medication for patients who had used ICS therapy previously from baseline to week 12 demonstrated that mean daily rescue albuterol use increased in the placebo group (+0.67 puffs/day) but remained stable in both ciclesonide treatment groups (+0.08 puffs/day for low dose, P < .0001; and +0.04 puffs/day for the high dose, P = .0002). For patients who had not used ICS therapy, the least square mean change from baseline showed a statistically significant reduction in rescue albuterol use from baseline to week 16 compared with placebo (P <= .0116). The 2 studies that specifically evaluated adverse events found similar profiles for patients with previous ICS use (3.3% low dose, 1.3% high dose, 8.6% placebo) and with no ICS use (3.5% low dose, 5.1% high dose, 3.5% combination dose, 6.7% placebo). The 2 studies that examined lung function found improvements for both groups. For patients who had used ICS treatment previously, the mean change from baseline at week 12 for FEV1 was maintained at 0.07 L with the low dose of ciclesonide, 0.01 L with the higher dose, and -0.12 L with placebo. Morning peak expiratory flow (PEF) decreased by 4.43 L/min with the low dose of ciclesonide, by 5.77 L/min with the high dose, and by 12.82 L/min with placebo. For patients with no previous ICS use, the mean change from baseline in FEV1 at week 16 was significantly improved by 0.30 L with the low dose of ciclesonide, 0.18 L with the high dose, and 0.07 L with placebo. The morning PEF was 39.56 L/min with the low dose of ciclesonide, 26.70 L/min with the high dose, and 3.39 L/min with placebo. Funding for these studies was provided by sanofi-aventis US and Altana Pharma US Inc.
[Presentation titles: Ciclesonide 80 Micrograms Twice Daily or 160 Micrograms Once Daily A.M. Significantly Maintained Lung Function Compared With Placebo in Patients With Asthma Who Have Previously Received an Inhaled Corticosteroid. Abstract P72; Ciclesonide 80 Micrograms TwiceDaily or 160 Micrograms Once Daily AM Maintains Variables of Asthma Control in Adults With Stable Mild-to-Moderate Asthma Previously Treated With an Inhaled Corticosteroid. Abstract P73; Ciclesonide 80 Micrograms Twice Daily or 160 Micrograms Once Daily AM Is Well Tolerated in Adults With Mild-to-Moderate Asthma Previously Receiving an Inhaled Corticosteroid. Abstract P74; Ciclesonide 80 Micrograms Twice Daily and 160 Micrograms Once Daily Significantly Improved Pulmonary Function Versus Placebo in Adults With Mild-to-Moderate Asthma Not Using Inhaled Corticosteroids. Abstract P75; Ciclesonide 80 Micrograms Twice Daily and 160 Micrograms Once Daily Improved Measurements of Asthma Control Versus Placebo in Adults With Mild-to-Moderate Asthma Not Using an Inhaled Corticosteroid. Abstract P76; Ciclesonide 80 Micrograms Twice Daily and 160 Micrograms Once Daily Is Well Tolerated in Patients With Mild-to-Moderate Asthma Not Using an Inhaled Corticosteroid. Abstract P77]
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