ANAHEIM, Calif., Nov. 8 /PRNewswire-FirstCall/ -- Long-term treatment with PULMICORT RESPULES(R) (budesonide inhalation suspension), a product of AstraZeneca Pharmaceuticals, L.P. , was well-tolerated in children with severe, oral corticosteroid-dependent asthma inadequately controlled on previous therapy, according to a new study(1) presented today at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting.
“Identifying an asthma therapy that is well-tolerated over a long-term period of use can be a challenging step in continuing the health of children with asthma, particularly those with severe asthma who are not controlled on other treatments,” said Bradley Chipps, M.D., Medical Director at the Capital Allergy and Respiratory Disease Center in Folsom, Calif. “This study showed that nebulized therapy with PULMICORT RESPULES may be an important long-term treatment to help manage children with severe asthma.”
The open label safety study evaluated 397 pediatric asthma patients between the ages of six months and eight years over the course of one and a half years. Doses of PULMICORT RESPULES were determined based on patient response to the medication with a median dose=0.8mg/d. No unexpected adverse events were observed. The incidence of adverse events probably or possibly related to treatment was low (12.3%).
“Pivotal studies showed short- and long-term treatment with nebulized PULMICORT RESPULES, at a wide range of doses, to be safe and well-tolerated in children with asthma, regardless of the severity of their disease(2-4),” said Philip E. Silkoff, M.D., Director of Clinical Research at AstraZeneca. “PULMICORT RESPULES is an important therapeutic option for young children with persistent asthma.”
ABOUT PULMICORT RESPULES
PULMICORT RESPULES (budesonide inhalation suspension) is delivered by a jet nebulizer. This type of nebulizer uses air pressure to turn the medicine into a mist that is then inhaled through a facemask or a mouthpiece. A compressor connected to the nebulizer controls the airflow to the facemask or the mouthpiece. This method may make delivery more consistent. PULMICORT RESPULES is the only nebulized inhaled corticosteroid approved in the United States for children with asthma as young as 12 months.
PULMICORT RESPULES is a preventive type medicine for use in children 12 months to eight years of age. PULMICORT RESPULES is not a quick-relief medicine (bronchodilator) and should NOT be used alone to treat an asthma attack.
In clinical studies, the side effects experienced with PULMICORT RESPULES and how often they happened were similar to what was experienced with a non-medicated mist (placebo). These side effects were not necessarily a result of taking PULMICORT RESPULES and included respiratory infection, runny nose, coughing, earache, viral infection, stomachache, oral thrush and nosebleeds. If your child is exposed to chicken pox or measles, consult your child’s health care professional. If your child is switching to PULMICORT RESPULES from an oral (syrup or pill) corticosteroid, carefully follow the health care professional’s instructions. This will help your child avoid health risks that may be linked with stopping the use of oral corticosteroids. PULMICORT RESPULES(R) (budesonide inhalation suspension) is a product of AstraZeneca Pharmaceuticals, L.P. For more information on the symptoms and triggers of asthma, as well as potential treatment options, parents can visit http://www.everydaykidz.com.
ABOUT CHILDHOOD ASTHMA
Asthma has become a serious problem in the United States, especially among children. In the year 2000, asthma resulted in 728,000 emergency department (ED) visits and 214,000 hospitalizations in patients under age 18,(5) and ED and hospitalization rates were highest among children four years of age and younger,(6) despite improvements in currently available asthma medications. Experts are unsure why this is the case, although one potential indicator is the lack of awareness and education about childhood asthma.
Approximately 6.3 million children under 18 years of age have asthma, which makes it the leading serious chronic illness among children.(7) Asthma is also the third leading cause of hospitalization among children under the age of 15 and the number one cause of school absenteeism attributed to a chronic condition.(7) Although asthma can be a life-threatening disease if not properly managed, the mild to moderate asthma that most children have can be controlled by treatment at home or in the doctor’s office.(8)
Common symptoms of childhood asthma include coughing either constant or intermittent; wheezing or a whistling sound audible when your child exhales; shortness of breath or rapid breathing, which may or may not be associated with exercise; and chest tightness.(8) Triggers of asthma range from smoke, airborne molds, pollens, dust, animal dander, exercise, cold air, many household and industrial products, air pollutants, scents or simple stress.(8)
ABOUT ASTRAZENECA
AstraZeneca is a major international health care business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of health care services. It is one of the world’s leading pharmaceutical companies with health care sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion health care business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit http://www.astrazeneca-us.com.
(1) Chipps B, Lyzell E, Cruz-Rivera M. A named-patient safety study of budesonide inhalation suspension in patients with severe, oral corticosteroid-dependent asthma. Poster presented at 61st Annual Meeting of American College of Allergy, Asthma & Immunology. November 4-9, 2005.
(2) Kemp JP, Skoner DP, Szefler SJ, et al. Once-daily budesonide inhalation suspension for the treatment of persistent asthma in infants and young children. Ann Allergy Asthma Immunol. 1999;83:231-239.
(3) Shapiro G, Mendelson L, Kraemer MJ, et al. Efficacy and safety of budesonide inhalation suspension (PULMICORT RESPULES) in young children with inhaled steroid-dependent, persistent asthma. J Allergy Clin Immunol. 1998;102:789-796.
(4) Baker JW, Mellon M, Wald J, et al. A multiple-dosing, placebo-controlled study of budesonide inhalation suspension given once or twice daily for treatment of persistent asthma in young children and infants. Pediatrics. 1999;103(2):414-421.
(5) Centers for Disease Control. Communications at the CDC: Entertainment Education. Available at http://www.cdc.gov/communication/tips/asthma_gnrl.htm#content. Accessed 9/21/05
(6) Centers for Disease Control. National Center for Health Statistics: Asthma Prevalence, Health Care Use and Mortality, 2002. Available at http://www.cdc.gov/nchs/products/pubs/pubd/hestats/asthma/asthma.htm. Accessed 9/21/05
(7) American Lung Association. Asthma in Children Fact Sheet - July 2005. Available at http://www.lungusa.org/site/apps/s/content.asp?c=dvLUK9O0E&b=34706&ct=67462. Accessed 9/21/05
(8) American Academy of Allergy, Asthma & Immunology. What is Asthma? Available at www.aaaai.org/patients/allergic_conditions/pediatric_asthma/what_is_asthma.stm Accessed 9/21/05
AstraZeneca Pharmaceuticals, L.P.
CONTACT: Heather Law of AstraZeneca, +1-302-898-8082 orheather.law@astrazeneca.com, or Cynthia Callaghan of AstraZeneca,+1-302-886-2959 or cynthia.callaghan@astrazeneca.com
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