ALTANA AG: Data Suggest Once-Daily Alvesco - Ciclesonide - Has Minimal Potential for Systemic and Local Adverse Effects.Business Editors/Health/Medical Writers BAD HOMBURG, Germany & ORLANDO, Fla.--(BUSINESS WIRE)--May 24, 2004 ALTANA AG (NYSE NYSE See: New York Stock Exchange :AAA AAA: see American Automobile Association. (Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied. ) (FWB:ALT): -- Studies Show No Effect on Normal Adrenal Function in Asthma Patients New data presented at the American Thoracic Society's 2004 International Conference show that once-daily treatment with the investigational therapy Alvesco(R) (ciclesonide) in mild-to-moderate asthma patients has no effect on normal adrenal function, as demonstrated by measurements of the hypothalamic-pituitary-adrenal (HPA)-axis. The HPA-axis is a major part of the neuroendocrine system, involving the interactions of the hypothalamus hypothalamus (hī'pəthăl`əməs), an important supervisory center in the brain, rich in ganglia, nerve fibers, and synaptic connections. It is composed of several sections called nuclei, each of which controls a specific function. , the pituitary gland and the adrenal glands. The HPA-axis is believed to be a focus of the body's reactions to stress and is recognized as a surrogate marker for common adverse effects associated with the body's reaction to extra cortisol cortisol (kôr`tĭsôl') or hydrocortisone, steroid hormone that in humans is the major circulating hormone of the cortex, or outer layer, of the adrenal gland. production, as seen with steroid treatment. (1) Alvesco(R) is an inhaled corticosteroid with novel release and distribution properties resulting in lung-targeted anti-inflammatory effects. Inhaled corticosteroids, considered to be the foundation of asthma treatment, work by reducing inflammation - the underlying disease process - in the lungs and airways. "In this study, ciclesonide has shown no identifiable effects on the normal cortisol system. This indicates that the drug may have no detectable effects on the adrenal glands", said Edward M. Kerwin, MD, medical director, Clinical Research Institute of Southern Oregon and lead investigator of the study. Trial Design and Results Effects of ciclesonide on the HPA-axis were investigated in two identical Phase III, multicenter, double-blind, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , placebo-controlled, parallel-group trials. Mild-to-moderate persistent asthma patients (n=1,015) twelve years and older received 80, 160 or 320micron g of ciclesonide, or placebo, once-daily in the morning for 12 weeks. HPA-axis function was assessed at baseline and at week 12 by determining peak serum cortisol levels stimulated by 1 micron g cosyntropin. Additionally, 24-hour urinary cortisol levels corrected for creatinine were assessed. Results of the two studies showed that no significant differences were observed from baseline to week 12 in cosyntropin-stimulated peak serum cortisol (micron g /dL) levels (PBO See Projected benefit obligation. : +0.49; CIC CIC circulating immune complexes. CIC Circulating immune complexes. See Immune complexes. 80: +0.22; CIC160: +1.51; CIC 320: +0.38), or 24-hour urinary cortisol levels corrected for creatinine (micron g /mg) for ciclesonide versus placebo (PBO: +0.0009; CIC80: -0.0013; CIC160: +0.0033; CIC 320: +0.0001). Pooled Analysis Shows Comparable Incidence of Local Side Effects to Placebo In another analysis presented at the Conference, adverse events affecting the throat (oropharynx oropharynx /oro·phar·ynx/ (-far´inks) the part of the pharynx between the soft palate and the upper edge of the epiglottis. o·ro·phar·ynx n. ) were pooled from 4,260 patients who received ciclesonide in clinical trials, and compared with 1,652 patients who received other inhaled asthma medications (budesonide, beclomethasone dipropionate or fluticasone proprionate), and 934 patients who received placebo. The ciclesonide patients experienced a lower incidence of oral candidiasis (fungal infection) than the placebo control group, and potential local adverse events rates were dose-independent and comparable to placebo. "These findings underscore the benefits of ciclesonide's novel release and distribution properties and suggest that ciclesonide exerts its effects in the airways, while minimizing risk elsewhere in the body," noted Professor Heinz-Werner Radtke, Head of research and development at ALTANA Pharma. "The low incidence of local side effects we see with ciclesonide is promising news for patients and their physicians." About Asthma Asthma is a chronic lung disease caused by airway inflammation and results in airway constriction in response to certain stimuli. It is characterized by a variety of symptoms including wheezing, coughing and a tightening of the airways, which causes shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. and can be life-threatening. According to the Global Initiative for Asthma This article is a stub. You can help Wikipedia by [ expanding it]. <includeonly></includeonly> The Global Initiative for Asthma (GINA) is a medical guidelines organisation which works with public health officials and health care professionals globally to (GINA GINA - Generic Interactive Application. An application framework based on Common Lisp and OSF/Motif, designed to simplify the construction of graphical interactive applications. ), more than 300 million people worldwide suffer from asthma. The prevalence of asthma is increasing by approximately 50 percent every decade and worldwide deaths from asthma total more than 180,000 annually. About Alvesco(R) In clinical trials, Alvesco(R) was shown to improve lung function, asthma symptoms, and reduce the need for medications necessary to treat acute asthma attacks. The most frequently reported adverse events seen in Alvesco(R) clinical trials were nasopharyngitis, headache and upper respiratory tract infection upper respiratory tract infection URI Infectious disease A nonspecific term used to describe acute infections involving the nose, paranasal sinuses, pharynx, and larynx, the prototypic URI is the common cold; flu/influenza is a systemic illness involving the URT . Alvesco(R) was approved in Australia and the United Kingdom this year, and has been submitted for approval in other countries around the world. Additionally, ALTANA's U.S. partner, Aventis, applied to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for approval of the asthma drug Alvesco(R) at the end of 2003. Teijin, ALTANA's partner in Japan, submitted an application for approval for Alvesco(R) in January 2004. (1) Webster's Online Dictionary, The Rosetta Edition. Available at: http://www.websters-online-dictionary.org/definition/english/st/ stress.html.(Due to the length of this URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. , it may be necessary to copy and paste To copy files from one location to another or to copy text and images from one document to another. All modern operating systems and applications have a copy and paste capability that is typically selected from an Edit menu. See cut and paste and Win Copy between windows. this hyperlink into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.) Accessed April 26, 2004. This press release contains forward-looking statements, i.e., current estimates or expectations of future events or future results. The forward-looking statements appearing in this press release include information on the presentation of study results. These statements are based on beliefs of ALTANA's management and information currently available to ALTANA. Many factors that ALTANA is unable to predict with accuracy could cause ALTANA's actual performance to be materially different from the one that may be expressed or implied by such forward-looking statements. Forward-looking statements speak only as of the date they are made. ALTANA does not intend, and does not assume any obligation, to update forward-looking statements to reflect facts, circumstances or events that have occurred or changed after such statements have been made. This press release is also available on the Internet at www.altana.com |
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