Navigation Links
New Patient Satisfaction Study With budesonide/formoterol Combination Therapy and fluticasone/salmeterol Combination Therapy in Adults With Asthma
Date:5/20/2008

WILMINGTON, Del., May 20 /PRNewswire-FirstCall/ -- A new open-label study evaluated patient satisfaction with budesonide/formoterol combination therapy and fluticasone/salmeterol combination therapy, as measured by the Asthma Treatment Satisfaction Measure (ATSM)(1). Patients participating in the study were ages 18 years and older with moderate to severe asthma(1) and had been previously treated with inhaled corticosteroids(1). Results were presented today at the International Conference of the American Thoracic Society held in Toronto, May 16-21, 2008.

Results showed that patients receiving budesonide/formoterol combination therapy administered as adjustable dosage reported significantly greater satisfaction on the ATSM overall (p=0.02) than patients receiving fluticasone/salmeterol combination therapy, especially in the categories of feel medication begins to work (p<0.001), dosing management (p<0.001), and timely relief of symptoms (p=0.037)(1). Patients receiving budesonide/formoterol combination therapy fixed dose reported significantly greater satisfaction for timely relief of symptoms (p=0.002) and feeling the medication begin to work (p=0.02) compared to patients receiving fluticasone/salmeterol combination therapy(1). Budesonide/formoterol combination therapy is not indicated for adjustable dosing in the U.S.

"These data showed that patients treated with budesonide/formoterol combination therapy fixed dose were more satisfied with the timeliness of their symptom relief than those patients treated with fluticasone/salmeterol combination therapy," said lead investigator Richard O'Connor, MD, of the University of California-San Diego.

About the ATSM

Patient satisfaction was assessed using the recently validated 11-item Asthma Treatment Satisfaction Measure (ATSM)(1). Scores range from 0-100, with the higher scores equaling greater satisfaction(1). Categories included symptom relief, onset of action, sensations that medications are working and self-management of dosing, as well as seven other related categories(1). The assessment of overall satisfaction was based on all the eleven ATSM items.

About the Study Design (Abstract A13)

Patient satisfaction was assessed in an open-label study involving 832 patients ages 18 years and older with moderate to severe asthma who were previously treated with ICS(1). After a 10-14 day run-in on previous ICS therapy, patients were randomized 2:1 to receive twice daily treatment with two inhalations of budesonide/formoterol combination therapy pressurized metered-dose inhaler (pMDI) fixed dose at 160/4.5 micrograms (mcg) (N=698) or twice daily treatment with one inhalation of fluticasone/salmeterol combination therapy dry powder inhaler (DPI) at 250/50 mcg (N=350)(1). After one month, patients on budesonide/formoterol combination therapy pMDI fixed dose were randomized 1:1 to continue budesonide/formoterol combination therapy pMDI fixed dose (N=333) or budesonide/formoterol combination therapy adjustable dose (N=330) at either once daily treatment with two inhalations of 160/4.5 mcg, twice daily treatment with two inhalations of 160/4.5 mcg, or twice daily treatment with four inhalations of 160/4.5 mcg for six months. The patients originally treated with fluticasone/salmeterol combination therapy remained on that medication (N=335)(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 Greater Than or Equal to 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.

References

(1) O'Connor, R.D., Patrick, D.L., Parasuraman, B., Martin, P., Goldman,

M. Patient Satisfaction During Treatment With Adjustable-Dose

Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI),

Fixed-Dose BUD/FM pMDI, and Fixed-Dose Fluticasone/Salmeterol Dry

Powder Inhaler (FP/SM DPI) [poster]. American Thoracic Society, May

16-21, 2008, Toronto. Abstract #A13.

(2) Symbicort Prescribing Information.


'/>"/>
SOURCE AstraZeneca
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Asthma Patients Not Adequately Controlled on ICS Alone More Likely to Benefit From Advair(R) Than Doubling the Dose of ICS
2. Alba Therapeutics Announces the Enrollment and Randomization of the First Patient in the Phase IIb Clinical Trial for Larazotide Acetate (AT-1001) for the Treatment of Active Celiac Disease
3. Boston Scientific Announces Program to Analyze Latitude(R) Patient Monitoring Data
4. Stable Stroke Patients More Likely to Die From a Nonstroke Cardiovascular Event Than a Further Stroke
5. Top Cancer Hospitals in Denmark and Netherlands First in Europe to Treat Patients With RapidArc(TM) Radiotherapy
6. Oncolytics Biotech Inc. Starts Patient Enrolment in U.K. Combination REOLYSIN(R)/Cyclophosphamide Trial
7. Edwards Lifesciences Celebrates One Million Heart Valve Patients and More at AATS 2008
8. CBI and PharmaVoice Announce Recipients of the Strategic Patient Adherence Awards
9. Wyeth and Progenics Receive Positive Opinion From European Committee for RELISTOR for the Treatment of Opioid-Induced Constipation in Advanced-Illness Patients
10. Signalife Awarded New U.S. Patent, System For, And Method Of, Monitoring Heartbeats Of A Patient
11. Atherotech VAP Cholesterol Test Meets Updated ADA, ACC Measurement and Treatment Guidelines for High Risk Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... ... February 22, 2017 , ... Park Systems , a leader in ... for all SPIE attendees and Park customers on Feb. 27, 2017 from ... San Jose Convention Center. The luncheon will feature a talk on Automated AFM ...
(Date:2/22/2017)... ... February 22, 2017 , ... ProMIS Neurosciences (“ProMIS” or ... neurodegenerative diseases, today announced it has issued a scientific white paper entitled “Results ... a series of commentaries from ProMIS’s scientific team offering insight into the Company’s ...
(Date:2/22/2017)... , Feb. 22, 2017 Origin (Origin Agritech, LLC, a ... and seed provider, and Arcadia (Arcadia Biosciences, ... develops and commercializes agricultural productivity traits and nutritional products, today announced ... biotechnology product developed in China to ... trials. ...
(Date:2/22/2017)... SAN DIEGO , Feb. 22, 2017 ... announced today expansion of its translational research program ... through establishment of laboratory facilities in San Diego.  ... San Diego BioLabs facility, a biotechnology incubator sponsored ... Sanofi. In November 2016, the Company ...
Breaking Biology Technology:
(Date:2/13/2017)...  RSA Conference -- RSA, a Dell Technologies business, ... enhance fraud detection and investigation across digital environments ... & Risk Intelligence Suite. The new platform is ... from internal and external sources as well as ... from targeted cybercrime attacks. "Fraudsters are ...
(Date:2/8/2017)... NEW YORK , Feb. 8, 2017 /PRNewswire/ ... an individual,s voice to match it against a ... voice such as pitch, cadence, and tone are ... systems require minimal hardware installation, as most PCs ... remotely for different transactions. Voice recognition biometrics are ...
(Date:2/8/2017)... -- Report Highlights The global biosurgery market ... in 2016 at a compound annual growth rate (CAGR) ... - An overview of the global market for biosurgery. ... 2015 and 2016, and projections of compound annual growth ... on the basis of product type, source, application, and ...
Breaking Biology News(10 mins):