Source: J Am Coll Cardiol  |  Posted 6 years ago

COPENHAGEN, DENMARK -- September 19, 2005 -- The results of the CONCEPT (CONtrol CEntred Patient Treatment) study, presented today at the European Respiratory Society annual congress (ERS) in Copenhagen, revealed that patients treated with formoterol/budesonide (FBC) adjustable maintenance dosing were almost twice as likely to experience asthma attacks (exacerbations) requiring hospital admission or oral steroid treatment than patients treated with salmeterol/fluticasone propionate (SFC) stable dosing.

This study has also shown that asthma patients treated with SFC stable dosing can experience an additional month of symptom-free days per year, compared with patients treated with FBC adjustable maintenance dosing.1

The Global Initiative for Asthma (GINA) guidelines state that the overall goal for successful management of asthma is to achieve and maintain control of the disease. This includes patients experiencing minimal or no symptoms or exacerbations.2 However, close to 95% of people with asthma currently lead a life that is compromised by poor asthma control, with a third of patients experiencing symptoms that regularly wake them at night, and almost 50% of patients having symptoms at least once per week during the day.3

The CONCEPT study was a multi-national, randomised, double-blind, double-dummy clinical trial. CONCEPT compared salmeterol/fluticasone propionate stable dosing with formoterol/budesonide adjustable maintenance dosing in 688 adult patients who were experiencing regular asthma symptoms.

During weeks 5-52, the median percentage of symptom-free days was significantly higher in the SFC treated group than in the FBC adjustable maintenance dosing treated group (73.8% vs. 64.9% respectively, p=0.030). This would equate to an average additional 32 symptom-free days per year in the SFC stable dosing group compared with FBC adjustable maintenance dosing treated patients.

The yearly mean exacerbation rate was 0.18 for SFC and 0.33 in the FBC adjustable maintenance dosing group (P =.008). This represents a 47% exacerbation rate reduction for patients on SFC stable dosing compared with FBC adjustable maintenance dosing.1

Dr. Mark FitzGerald, University of British Columbia and lead investigator of CONCEPT said, "Asthma patients really should expect to lead a symptom-free life. The CONCEPT study shows that regular therapy with salmeterol and fluticasone achieves excellent asthma control when compared to an adjustable dosing strategy with budesonide and formoterol. Lack of effect among patients assigned to the adjustable dosing arm may, in part, have been due to once a day dosing for many patients in this group".

More patients in the salmeterol/fluticasone propionate stable dosing treatment group also experienced a significant improvement in quality of life (QoL). QoL was measured using the Asthma Quality of Life Questionnaire (AQLQ), which assesses both the physical and emotional impact of the disease on patients.1

Dr. FitzGerald continued, "Both asthma symptoms and asthma attacks have a considerable negative impact on patient health. These symptoms can often prevent patients from carrying out activities of daily living and taking part in leisure and social activities. We should be striving to improve quality of life by effectively treating and managing the disease."

According to additional data presented at ERS, physicians can improve the assessment and monitoring of patients' asthma control using the new Asthma Control Test? (ACT?). The ACT? is a simple, independently validated questionnaire which provides a rapid, reliable assessment of asthma control. Developed by an independent working group of specialist and primary care physicians, the ACT? requires patients to answer five simple questions and provides a numerical target indicating their level of asthma control.4

The World Health Organisation (WHO) estimates that 300 million people worldwide have asthma,5 and it has become considerably more common in both children and adults around the world in recent decades. Recent estimates suggest that this figure will increase by an additional 30 - 50% by 2025.5 Asthma is one of the most common chronic diseases in the world.
Notes to editors

-? The 12-month treatment period comprised of a one month stabilisation phase when both groups received stable dose treatment, which was immediately followed by an 11-month period where SFC stable and FBC adjustable maintenance dosing strategies were compared.

-? Patients treated with salmeterol/fluticasone propionate stable dosing experienced significantly more symptom-free days compared to patients treated with FBC adjustable maintenance dosing (median 59% compared with 52%; p=0.034, weeks 1-52, which equates to an average difference of 24 days per year). The difference in the percentage of symptom-free days over weeks 5-52 (stable dosing vs. adjustable maintenance dosing) increased to 74% for patients receiving salmeterol/fluticasone propionate compared with 65% for patients receiving formoterol/budesonide (p=0.030), which equates to an average 32 more symptom-free days per year for salmeterol/fluticasone propionate patients.

-? Patients receiving stable dose salmeterol/fluticasone propionate had almost half the rate of exacerbations that required either a course of oral steroids, an emergency room visit or a hospitalisation, compared with patients receiving formoterol/budesonide AMD (adjusted annual rate of 0.18 compared with 0.33 exacerbations; p=0.008). The total numbers of exacerbations recorded were 50 on stable dose salmeterol/fluticasone propionate and 96 on formoterol/budesonide adjustable maintenance dosing.

-? Both treatments improved daily symptom scores and night-time awakenings due to symptoms. There were no differences found between treatments for these end points. The incidence of adverse events was similar in both the salmeterol/fluticasone propionate stable dosing and formoterol/budesonide adjustable maintenance dosing groups. Serious adverse events were reported in 3% of patients in each group.

-? The Asthma Control Test (ACT?) is available at www.asthmacontroltest.com.

REFERENCES:
1. FitzGerald M et al. Improved control of symptoms and exacerbation rates with stable dose treatment with salmeterol/fluticasone propionate (SFC) compared with adjustable maintenance dosing with formoterol/budesonide (FBC). Oral presentation at ERS 2005 (abstract no. 2765).
2. Global Initiative for Asthma. Global strategy for asthma management and prevention. NIH publication No 02-3659. Issued January 1995 (updated 2004), Management Segment (Chapter 7): Updated from the 2003 document. www.ginasthma.com.
3. Rabe KF et al. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Resp J 2000;16:802-807.
4. Schatz M et al. Empirical evidence supporting the ACT TM score to identify/monitor patients with poorly controlled asthma. Oral presentation at ERS 2005 (abstract no.167).
5. Masoli M et al. The Global Burden of Asthma, Global Initiative for Asthma report, May 2004, www.ginasthma.com.

SOURCE: GlaxoSmithKline