KENILWORTH, N.J., Nov. 8 /PRNewswire-FirstCall/ -- Nasal congestion is the most bothersome symptom for patients with allergic rhinitis, according to a national patient survey presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting in Anaheim, Calif. The survey of over 2,000 respondents also showed that nasal congestion is the number-one symptom they want to prevent and is the most likely symptom to trigger a visit to the doctor for relief.
“My allergy patients tell me that nasal congestion is a real nuisance, affecting them in many areas of their lives,” said Eric J. Schenkel, M.D., Director of the Valley Clinical Research Center in Easton, Pa.
The survey also revealed how symptoms can affect daily activities: * Half of adults and children say congestion affects them at night, making it difficult to fall asleep or causing them to wake during the night. * 59 percent of adult sufferers say nasal congestion affects them at work. * According to parents, nasal congestion affects 61 percent of children with allergic rhinitis at school.
Nasal allergy symptoms caused by allergic rhinitis can occur seasonally due to pollen, or perennially as a result of dust mites, pet dander or mold. One in every five adults and approximately 40 percent of children are affected by allergic rhinitis,(1) which is responsible for six million lost work days and two million lost school days in the U.S. each year.(2)
According to an analysis of pooled data from four clinical studies presented at the meeting, NASONEX(R) (mometasone furoate monohydrate) provides effective relief of nasal congestion associated with seasonal allergic rhinitis. The data demonstrated that even patients with the most severe congestion saw significant improvement in their nasal congestion while taking NASONEX.
“According to the analysis, patients taking NASONEX experienced significantly greater improvement in nasal congestion over the two-week period compared with those receiving placebo,” said William Berger, M.D., a clinical professor in the Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine and lead researcher in the study.
Intranasal corticosteroids are recommended first-line therapy when nasal congestion is the primary symptom of a patient’s allergic rhinitis, according to the “Allergy Report” published by the American Academy of Allergy, Asthma & Immunology (AAAAI).(3)
“Many patients assume they should take an antihistamine to treat all allergy symptoms. But when nasal congestion is the main problem, a prescription intranasal corticosteroid, like NASONEX, is a good treatment option,” said Dr. Berger.
NASONEX is the only once-daily prescription intranasal corticosteroid approved to help prevent seasonal nasal allergy symptoms, including nasal congestion, in adults and children 12 years of age and older when NASONEX is started 2 to 4 weeks prior to allergy season, and the only intranasal corticosteroid approved to treat nasal allergy symptoms, including nasal congestion, in patients as young as 2 years of age.(4)
About the Survey
An online survey of 2,002 adults who either had allergic rhinitis (AR) with nasal congestion (n=1491) or were the caregiver of a child with AR and nasal congestion (n=511) was performed in May and June 2004 to assess the impact of nasal congestion on sufferers. The sample was recruited from the Roper Public Affairs national consumer panel. Data were normalized to reflect the U.S. population by age within divisions of sex, education and region, based on census data. The sampling error margin was +/- 2 percent.
About the Placebo-Controlled Studies
To evaluate the efficacy and safety of NASONEX in the treatment of moderate and severe nasal congestion, data were pooled from four randomized, double-blind, placebo-controlled trials of NASONEX 200 mcg once-daily in subjects with symptomatic seasonal allergic rhinitis (SAR). The primary efficacy endpoint in this pooled analysis was the subject evaluated two-week average of morning and evening nasal congestion scores. Patients aged 12 years or older received NASONEX 200 mcg (n=494) or placebo (n=497) once-daily in the morning for 14 days or 28 days. Nasal congestion was scored twice daily by patients using a 4-point scale from 0 (none) to 3 (severe). Improvements in nasal congestion over two weeks were analyzed for baseline congestion scores of increasing severity (i.e., greater than 2.5, greater than 2.75 and 3.0) using two-way analysis of variance.
Mean nasal congestion scores at baseline were 2.24 for NASONEX-treated patients (n=494) and 2.25 for placebo recipients (n=497). All patients receiving NASONEX had significantly greater improvement from baseline in nasal congestion over two weeks compared with those receiving placebo (mean improvement 0.67 vs. 0.35 points, P<0.001). Significant improvement in nasal congestion score was seen even in patients with the most severe congestion. For patients with a baseline score of 3.0, results showed a 0.46 difference between NASONEX and placebo after two weeks of treatment (-0.98 change in the NASONEX group, compared to -0.52 change in placebo; P<0.001). Patients with a baseline score greater than 2.75 showed a 0.37 difference (NASONEX, -0.98; placebo, -0.61; P<0.001) and patients with a baseline score greater than 2.5 showed a 0.29 difference (NASONEX, -0.91; placebo, -0.62; P<0.001).
About Allergic Rhinitis
Allergic rhinitis encompasses the outdoor symptoms of seasonal allergic rhinitis (SAR) and the indoor symptoms of perennial allergic rhinitis (PAR), affect approximately 36 million people in the United States.(5) An estimated 40 to 50 percent of people with allergies are believed to suffer from both SAR and PAR; 20 to 30 percent from SAR alone; and 15 to 30 percent from PAR alone.(6) Nasal allergy symptoms, which classically include sneezing, itching, nasal discharge, and congestion, can have a significant impact on everyday activities at work, school and leisure time. In addition, there is a growing body of evidence that points to an association between allergies and even more serious conditions such as asthma.(7)
About NASONEX
Originally approved by the U.S. Food and Drug Administration (FDA) in 1997, NASONEX is an intranasal corticosteroid related to cortisol, a hormone produced naturally by the body, and when used as directed, is safe, nonsedating and not addictive.(4) As a pharmaceutical preparation, which contains no ethanol or ethyl alcohol, scent-free NASONEX is alcohol-free. NASONEX reduces nasal congestion caused by an allergic reaction. NASONEX provides relief from symptoms of seasonal and perennial allergic rhinitis, including nasal congestion, sneezing and an itchy, runny nose. Side effects were generally mild and included headache, viral infection, sore throat, nosebleeds and coughing.(4) NASONEX also is the first and only nasal inhaled steroid approved for the treatment of nasal polyps in adults 18 years of age and older.
Visit www.NASONEX.com for more information on preventing and treating nasal allergy symptoms. For additional important product information, full prescribing information is available at: http://www.spfiles.com/pinasonex.pdf.
About Schering-Plough Corporation
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including statements related to NASONEX and the potential market for NASONEX. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statements. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these or other factors that may impact the forward- looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including the company’s third quarter 2005 10-Q.
References: 1. The American Academy of Allergy, Asthma & Immunology, Inc., The Allergy Report, 2000. 2. deShazo RD. Allergic rhinitis. Cecil Textbook of Medicine. 21st edition. St. Louis. W.B. Saunders Company; 2000: 1445-1450. 3. The American Academy of Allergy, Asthma & Immunology, Inc., The Allergy Report, 2000, Vol. 2:p.16. 4. NASONEX(R) Product Information. Schering Corporation. 5. Nathan, R.A., Meltzer, E.O., Selner, J.C., Storms, W. “Prevalence of Allergic Rhinitis in the United States.” Journal of Allergy and Clinical Immunology (1997) 99:S808-14. 6. (C) Decision Resources, Inc. 7. Linneberg A, Henrik Nielsen N, Frolund L, et al. The link between allergic rhinitis and allergic asthma: a prospective population-based study. The Copenhagen Allergy Study, Allergy 2002; 57: 1048-52.
Schering-Plough Corporation
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