Patients taking a stable daily dose of combination treatment experience substantially fewer symptoms and exacerbations than those who adjust their own treatment according to symptoms -

-- Combination treatments (inhaled corticosteroid plus long-acting bronchodilator) are a key medicine for patients with asthma.

-- A new study (CONCEPT) has shown that patients who adjust their treatment in response to symptoms experience significantly more symptoms and exacerbations than those on a stable dose regimen.

Thousands of asthma patients on combination therapy could be suffering symptoms and costly exacerbations (asthma attacks) because they adjust their medication in reaction to their symptoms, rather than taking a stable daily treatment, according to the results of a new study published today.

The CONCEPT study1 found that stable daily dosing was significantly superior to symptom-led dosing across several endpoints, with patients benefiting from:

-- A 47% reduction in exacerbation rate (p=0.008)

-- More than one extra month (32 days) of complete freedom from symptoms every year

-- 50% less reliever medication use (p=0.006)

-- Reduced use of oral steroids (46% fewer patients required oral steroids in the stable dosing arm)

These benefits were maintained even when compared to a population who had closely adhered to the symptom-led dosing approach.

"A patient's symptoms do not necessarily reflect the underlying inflammation in their lungs," commented Professor Ashley Woodcock, UK study investigator, Wythenshawe Hospital, Manchester. "This study shows that sustained medication may be more effective at controlling symptoms of asthma than patient controlled variable dosing."

CONCEPT is the first and only randomised, double-blind, double-dummy, clinical trial to investigate the optimum treatment approach to prevent asthma symptoms and exacerbations using the currently available combination therapies.

The year-long study involved 688 asthma patients in the UK and 14 other countries. Patients were randomised to receive either a stable daily dose of salmeterol/ fluticasone propionate (SeretideTM, 50/250ug BID) or a symptom-led dose of formoterol/ budesonide (SymbicortTM, 6/200ug 2x BID). Patients on Symbicort were instructed to increase or reduce their dose in response to their current asthma symptoms. The two treatment regimens reflect current practice in the UK.

Professor Andrew Greening, Professor of Pulmonary Diseases and Consultant Physician, Western General Hospital, Edinburgh commented, "I have been concerned for a long while that healthcare professionals and patients are not ambitious enough about asthma control.

Too often regular symptoms are seen as acceptable, so long as severe asthma does not occur. A strategy of symptom driven use of therapy seems to view this as acceptable.

Gareth Field
Ketchum
(020) 7611 3668
gareth.fieldketchum

Katie Banks
Ketchum
(020) 7611 3619
katie.banksketchum

Notes to editors:
CONCEPT stands for CONtrol CEntred Patient Treatment.

References:
FitzGerald JM, Boulet L-P, Follows RAM. CONCEPT: A randomised, double-blind, double-dummy comparison of salmeterol/fluticasone propionate using a stable dosing regimen with formoterol/budesonide using an adjustable maintenance dosing regimen in persistent asthma. Clinical Therapeutics, online publication 23 March 2005. "Asthma patients really deserve more, and should expect to have a symptom-free life with full daily activities," he continued. "Combination inhalers have the potential to deliver this to a significant number of patients. The results of the CONCEPT study indicate that getting patients to take such therapy on a regular twice daily basis is probably the most effective way of achieving this ambitious level of asthma control." "Rather than simply reacting to symptoms, any approach that proactively keeps the patient as symptom-free and exacerbation-free as possible has to be good news," concluded Dr Tony Crockett, GP in Shrivenham. "It is actually a lot simpler for healthcare professionals to keep patients on a regular dose of treatment. Now we know that simpler treatment also produces better outcomes." Both treatments were well tolerated with few and similar adverse events occurred in patients in both arms. - ENDS - For more information, please contact: Gareth Field Ketchum (020) 7611 3668 gareth.fieldketchum Katie Banks Ketchum (020) 7611 3619 katie.banksketchum Notes to editors: CONCEPT stands for CONtrol CEntred Patient Treatment. References: 1. FitzGerald JM, Boulet L-P, Follows RAM. CONCEPT: A randomised, double-blind, double-dummy comparison of salmeterol/fluticasone propionate using a stable dosing regimen with formoterol/budesonide using an adjustable maintenance dosing regimen in persistent asthma. Clinical Therapeutics, online publication 23 March 2005.