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PJ Online homeThe Pharmaceutical Journal
Vol 273 No 7322 p594
23 October 2004

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GSK asthma trial suggests total control is possible

A combination of salmeterol and fluticasone propionate (Seretide) should be the preferred treatment option for patients with uncontrolled asthma. This is the conclusion of the GOAL (gaining optimal asthma control) study, published in the American Journal of Respiratory and Critical Care Medicine last week (2004;170:836).

Researchers compared salmeterol plus fluticasone with fluticasone (Flixotide) alone in 3,421 patients aged between 12 and 80 years. They found that more patients with uncontrolled asthma achieved total control with the combination product.

However, the trial has prompted a critical response from AstraZeneca, manufacturer of Symbicort (budesonide plus formoterol), which says that the study reconfirms an accepted approach to asthma management — the addition of a long-acting bronchodilator to an inhaled steroid. It also pointed out that the study involved a step-up approach to asthma management. “No step down strategy was implemented, which is not in line with the [British Thoracic Society/Scottish Intercollegiate Guidelines Network] guidelines recommendation of stepping down therapy once control is achieved,” the company declared.

The one-year GOAL study aimed to achieve total control of asthma symptoms. Total control was defined as complete freedom from asthma signs or symptoms (no symptoms, no rescue salbutamol use, no exacerbations, no night-time awakenings and no emergency visits) for at least seven out of every eight weeks. Treatment was stepped up until total control was achieved or up to a maximum of 500µg corticosteroid twice a day.

Data from the study show that, after one year, 41 per cent of patients achieved total control with combination therapy as opposed to 28 per cent of patients given steroid alone.

Anna Murphy, consultant respiratory pharmacist, Glenfield Hospital, Leicester, commented: “We all know that asthma control in the UK is sub-optimal and one key reason for this is non-compliance with medication. The GOAL study shows that if patients take their medication their control can be significantly improved.”

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