Once- or Twice-Daily Treatment With PULMICORT RESPULES(R) Significantly Increased Percentage of Days Asthma Is Controlled

Main Category: Respiratory / Asthma
Also Included In: Medical Devices / Diagnostics;  Pediatrics / Children's Health;  Clinical Trials / Drug Trials
Article Date: 14 Nov 2006 - 0:00 PST

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Children treated with PULMICORT RESPULES(R) (budesonide inhalation suspension) either once or twice daily experienced a significantly greater increase in the percentage of asthma-control days compared to those receiving placebo. These results are being presented at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI), held in Philadelphia on November 9-15. Asthma-control days were defined as days when children were free of symptoms and did not use rescue medications during the day and night. Control of asthma symptoms during the day and night and reduction of the need for rescue medication is an important goal of asthma therapy in keeping with current National Asthma Education and Prevention Program (NAEPP) guidelines.

"The primary goal of asthma treatment is control, but it cannot be achieved by treating only when symptoms appear, as commonly practiced," said Philip Silkoff, MD, Medical Director, AstraZeneca, and coauthor of the study. "The analysis confirms the value of daily therapy with PULMICORT RESPULES in helping to achieve this goal, by improving both objective and subjective measures of asthma control."

The retrospective analysis examined data from three randomized, double-blind, placebo-controlled, 12-week studies involving more than 1,000 patients ages 6 months to 8 years with moderate or mild persistent asthma. Patients were treated with PULMICORT RESPULES 0.25, 0.5 or 1.0 mg either once or twice daily. PULMICORT RESPULES is indicated in children 12 months to eight years of age.

Both once- and twice-daily treatment with PULMICORT RESPULES improved asthma-control days, a composite index of days and nights with no asthma symptoms or rescue medication use. Improvements in the percentage of asthma-control days ranged from 21.2 percent to 30.6 percent for the PULMICORT RESPULES treatment groups, compared with improvements ranging from 9.6 percent to 17.8 percent for the placebo groups. The significance of differences in effect between active drug and placebo varied by study.

About PULMICORT RESPULES(R) (budesonide inhalation suspension)

PULMICORT RESPULES 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. It 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, an inhaled corticosteroid, is not a quick-relief medication and should NOT be used to treat an acute asthma attack. In studies, side effects were similar to those experienced with placebo. These included respiratory infection, runny nose, coughing, earache, viral infection, stomachache, oral thrush, and nosebleeds. If switching to PULMICORT RESPULES from an oral (syrup or pill) corticosteroid, follow the doctor's instructions to help avoid health risks. Tell the doctor if your child is exposed to chicken pox or measles.

PULMICORT RESPULES(R) (budesonide inhalation suspension) is a product of AstraZeneca, (NYSE: AZN). For more information on the symptoms and triggers of asthma, as well as potential treatment options, parents can visit http://www.everydaykidz.com.

A full copy of the prescribing information is available at http://www.pulmicortrespules.com.

About Childhood Asthma

According to the American Lung Association, asthma currently affects an estimated 6.2 million children under 18, and of those, four million suffered from an asthma attack or episode in 2004.(2) In the previous year, more than 600,000 children under 15 visited emergency rooms because of their asthma.(2)

Asthma accounted for 14 million lost school days in 2004, making it the leading cause of school absenteeism attributable to chronic conditions.(2) In fact, a recent survey found more than a third (39%) of parents missed work in the past year as a result of their child's asthma, and more than one in 10 (11%) missed more than a week of work in the past year as a result of their child's condition.(3)

Asthma is characterized by excessive sensitivity of the lungs to various stimuli resulting in swelling of the airways and tightening of the muscles surrounding the airways. Symptoms include wheezing, cough, chest tightness, and shortness of breath. Asthma can be triggered by viral respiratory infections ("colds"), exercise, cigarette smoke, animal dander, pollens, dust, cockroaches, molds, cold air or sudden temperature change.(2)

Inflammation of the airways is the underlying problem in asthma, which will improve when anti-inflammatory medications are used regularly. Asthma symptoms can be prevented when anti-inflammatory medications are used daily.

About AstraZeneca

AstraZeneca (NYSE: AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca recently expanded eligibility requirements for its Patient Assistance Program to allow a family of four earning $60,000, or individuals earning $30,000, who do not have prescription drug coverage, to qualify to get their AstraZeneca medicines for free.

AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

AstraZeneca Respiratory is dedicated to the development of new, effective treatments that help improve lung health and enhance the lives of adults and children living with asthma. Through innovative respiratory products, including SYMBICORT(R), PULMICORT RESPULES(R), PULMICORT TURBUHALER(R), and RHINOCORT AQUA(R), AstraZeneca is providing patients with effective treatment options to help manage their conditions.

For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.

(1) Baker JW, Kemp J, Shapiro G et al. Improvements in asthma control in pediatric patients treated with once-daily or twice-daily nebulized budesonide inhalation suspension. Poster presented at 62nd Annual Meeting of American College of Allergy, Asthma and Immunology. November 9-15, 2006.

(2) American Lung Association. Asthma & Children Fact Sheet. Available at: http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=44352. Accessed 10/26/06

(3) Asthma Action America(R). Children & Asthma in America: Personal Consequences of Asthma. Available at: http://www.asthmainamerica.com/personal_consequences.html. Accessed 3/10/06

AstraZeneca
http://www.astrazeneca-us.com