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Newly Released Data on Onset of Effect and Patient Perception With SYMBICORT in Adults With Asthma
Date:9/10/2008

WILMINGTON, Del., Sept. 10 /PRNewswire-FirstCall/ -- Newly released results from two previously published studies demonstrated patients receiving the maintenance combination asthma therapy SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol achieved bronchodilation, or opening of the airways, within 15 minutes(1) and reported feeling their medication begin to work right away.(1) The studies evaluated onset of bronchodilation and patient perception of onset of effect(1) of SYMBICORT compared with placebo and its individual components, budesonide pressurized metered-dose inhaler (pMDI) and formoterol dry powder inhaler (DPI), in patients with asthma.(1) These data, which were published today in the Annals of Allergy, Asthma and Immunology, also showed patients were more satisfied with how quickly they felt their medication working compared with patients taking placebo.(1) SYMBICORT is a combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.(2) SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma.(2)

"The data showed that patients receiving SYMBICORT reported they could feel their medication begin to work right away and were satisfied by how quickly their medication began to work,"(1) said lead investigator Harold Kaiser, Clinical Professor of Medicine, University of Minnesota Medical School.

Results of both studies (Study I and Study II) showed that more patients taking SYMBICORT achieved onset of clinically significant bronchodilation within 15 minutes postdose at randomization (median time, 13 minutes), compared with budesonide pMDI and placebo (P<.001).(1) Time to onset of clinically significant bronchodilation of SYMBICORT and formoterol DPI were similar.(1)

Additionally, results showed that a significantly greater percentage of patients receiving SYMBICORT versus those receiving budesonide pMDI and placebo reported feeling their study medication begin to work right away (P less than or equal to .004; end of week 1).(1) Similar results (P<.001) were observed for patients' satisfaction with how quickly they felt their medication begin to work (except for SYMBICORT versus budesonide pMDI in Study 1 [P=.073]).(1) The results seen at the end of treatment were similar to those demonstrated at randomization.(1) Patient perception of onset of effect of SYMBICORT and formoterol DPI were similar.(1)

In both studies, the majority of reported adverse events were mild or moderate in intensity.(3,4) The most common adverse events reported in Study I were headache, upper respiratory tract infection and nasopharyngitis, also known as the common cold.(3) The most common adverse events reported in Study II were nasopharyngitis, headache and pharyngolaryngeal pain.(4)

About the Design of Study I and Study II

Onset of bronchodilation and patient perception of onset of effect was assessed in two 12-week randomized, double-blind, placebo-controlled studies in asthma patients who were previously treated with inhaled corticosteroids (ICS),(1) either alone or in combination with other asthma maintenance therapy. Study I involved 596 patients ages 12 years and older with moderate to severe persistent asthma; Study II involved 480 patients ages 12 years and older with mild to moderate persistent asthma.(1) Each study included a two-week run-in period during which patients discontinued use of their current asthma therapy and received single-blind budesonide pMDI 80 micrograms (mcg) two inhalations twice-daily (Study I) or placebo (Study II) and albuterol as needed for rescue.(1)

After run-in, patients within Study I were randomized to receive treatment with two inhalations twice-daily of SYMBICORT 160/4.5 mcg, two inhalations twice-daily of budesonide pMDI 160 mcg + two inhalations twice-daily of formoterol DPI 4.5 mcg, two inhalations twice-daily of budesonide pMDI 160 mcg, two inhalations twice-daily of formoterol DPI 4.5 mcg, or placebo.(1) Patients within Study II after run-in were randomized to receive treatment with two inhalations twice-daily of SYMBICORT 80/4.5 mcg, two inhalations twice-daily of budesonide pMDI 80 mcg, two inhalations twice-daily of formoterol DPI 4.5 mcg or placebo.(1)

Onset of clinically significant bronchodilation was defined as the time to achieve a 15 percent improvement in FEV1 from the predose FEV1 after study medication was administered.(1) Forced expiratory volume in one second (FEV1) quantifies how much air a person can exhale during a forced breath in the first second of exhalation.(5)

About Patient Perception of Onset of Effect

In these studies, perception of onset of effect was assessed in two ways.(1) Patients completed the Onset of Effect Questionnaire(c)(OEQ), a validated self-administered questionnaire.(1) Answers to statements were recorded in an electronic diary at the end of weeks one through 12:(1) They included: during the past week (1.) you could tell your study medication was working; (2.) you could feel your study medication begin to work right away; (3.) you felt physical sensations shortly after taking your study medication that reassured you that it was working; and (4.) you were satisfied with how quickly you felt your study medication begin to work.(1) Each question in the OEQ was rated by patients using a five-point scale: "strongly disagree," "somewhat disagree," "neither agree nor disagree," "somewhat agree," or "strongly agree."(1)

In addition, patients were asked a single perception of onset of effect question -- "Can you feel your study medication working?" -- four times during the first hour post-dose at the clinic on the day of randomization, at the end of week 2, and at the last study visit at the end of week 12.(1)

About SYMBICORT

SYMBICORT is a combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.(2) Administered twice daily, SYMBICORT is a combination of two proven asthma medications -- budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA).(2) SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma.(2)

Important Safety Information

Long acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled U.S. study compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT.

SYMBICORT is not indicated for the relief of acute bronchospasm.

SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.

Particular care is needed for patients who are transferred from systemically active corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Patients who are receiving SYMBICORT twice daily should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.

Common adverse events reported in clinical trials, occurring in > 5 percent of patients, regardless of relationship to treatment, including nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.

Please see full Prescribing Information and visit http://www.MySYMBICORT.com.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information visit http://www.astrazeneca-us.com.

Onset of Effect Questionnaire is a copyright of the AstraZeneca group of companies. (c) 2007 AstraZeneca Pharmaceuticals LP. All rights reserved.

References

(1) Kaiser, H., et al. Onset of Effect of Budesonide and Formoterol Administered Via One Pressurized Metered-Dose Inhaler in Adults and Adolescents with Asthma Previously Treated with Inhaled Corticosteroids. Annals of Allergy, Asthma and Immunology. 2008; 101(3):295-303. Published 09 September 2008. Available at: http://lysander.annallergy.org/vl=4825828/cl=18/nw=1/rpsv/cw/acaai/10811206 /v1 01n3/s12/p295.

(2) SYMBICORT Prescribing Information.

(3) Noonan M., Rosenwasser, L., Martin, P., O'Brien, C., O'Dowd, L. A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of SYMBICORT(R) (160/4.5 micrograms) versus its Mono-Products (budesonide and formoterol) in Adolescents (greater than or equal to 12 Years of Age) and Adults with Asthma. Drugs. 2006; 66(17):2235-2254. Accessed 05 August 2008. Available at: http://www.astrazenecaclinicaltrials.com.

(4) Corren, J., Korenblatt, P.E., Miller, C.J., O'Brien, C.D., Mezzanotte, W.S. A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of SYMBICORT(R) pMDI (80/4.5 micrograms) versus its Monoproducts (budesonide and formoterol) in Children (greater than or equal to 6 Years of Age) and Adults with Asthma - SPRUCE 80/4.5. Clin Therapeutics. 2007; 29:823-843. Accessed 05 August 2008. Available at: http://www.astrazenecaclinicaltrials.com.

(5) What Are Lung Function Tests? National Heart, Lung and Blood Institute. Accessed 07 August 2008. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/lft/lft_all.html.


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