Flexible dose asthma medication significantly reduces exacerbations

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Canadian researchers have shown that flexible dosing with budesonide/formoterol was more effective in reducing the number of asthma exacerbations than a traditional fixed-dose regimen. The adjustable treatment plan allowed patients to gain control of their asthma using an overall lower dose of inhaled corticosteroid and resulted in an overall cost-savings compared to fixed-dose treatment.

“Fixed-dose regimens have often led patients to take more medication than they need during periods of control, or take less medication than they need during periods of worsening asthma,” said lead investigator Dr. Mark FitzGerald, professor of respiratory medicine at the University of British Columbia and staff physician at Vancouver Hospital and Health Sciences Centre (VHHSC). “An adjustable treatment strategy allows patients to alter their medication to the symptoms in order to achieve better control of their asthma.”

He added that the guidelines for asthma care in Canada stress the importance of adapting treatment to the individual needs of patients. The establishment of a patient treatment plan is necessary to obtain and maintain asthma control as a majority of the almost three million Canadians with asthma do not have their condition under control, said FitzGerald. According to the Canadian Lung Association, approximately 500 Canadian adults die each year from asthma.

“As patients experience periodic variations in their asthma symptoms over time, it makes sense that the most appropriate amount of medication required to maintain control also varies over time,” said FitzGerald. “A flexible dosing schedule provides more effective control, and uses less steroid, both of which are consistent with existing treatment guidelines.”

Dr. FitzGerald recently presented the results of his study at the World Allergy Organization Congress (WAO) in Vancouver, BC. The study was a five-month randomized open-label trial conducted in 95 primary care centers in Canada comparing adjustable and fixed treatment strategies with combination budesonide/formoterol therapy in patients with asthma.

The budesonide/formoterol combination — a combination consisting of the inhaled corticosteroid (budesonide) and bronchodilator (formoterol) in a single inhaler — has been developed for the treatment of patients whose asthma is inadequately controlled by inhaled glucocorticosteroids alone. The combination therapy, known as Symbicort® Turbuhaler®, is available in two strengths: 100μg budesonide/6μg formoterol and 200μg budesonide/6μg formoterol.

Of the 1,193 patients entered into the one-month run-in on a fixed budesonide/formoterol regimen (stratified to 100μg/6μg or 200μg/6μg) two inhalations twice daily, 995 patients were randomized to either continue the fixed dose treatment strategy or to receive budesonide/formoterol adjustable treatment. Patients in the fixed and flexible treatment arms were stratified to receive either 100μg/6μg or 200μg/6μg budesonide/formoterol based on the strength of previous treatments with inhaled corticosteroids.

Patients in the adjustable treatment arm were able to step down to one inhalation twice daily when symptoms were controlled and were instructed to increase the maintenance dose to four inhalations twice daily for seven to 14 days at the first sign of asthma worsening. Patients in the fixed treatment arm, on the other hand, continued with the maintenance dose of two inhalations of budesonide/formoterol twice daily, and additional measures were taken to gain asthma control at the discretion of the investigators.

Significantly fewer patients experienced exacerbations in the adjustable treatment arm compared with the fixed treatment arm. The adjustable treatment regimen reduced the mean number of exacerbations by 57 per cent and the mean number of severe exacerbations by 47 per cent compared with a fixed treatment plan. An asthma exacerbation was defined as the need for additional inhaled and/or oral corticosteroids, ER treatment due to asthma worsening, an asthma-related serious adverse event, or study withdrawal due to the need for additional therapy.

Patients in the adjustable treatment arm also used significantly fewer inhalations of budesonide/formoterol compared with those in the fixed treatment arm. In fact, more than 93 per cent of patients in the flexible dose arm reduced their maintenance dose. As a result, said Dr. FitzGerald, the total cost per patient was 36 per cent lower with flexible dosing, resulting in an approximate savings of $141.00 CDN per person over the five months of treatment.

“The asthma patients randomized to flexible dosing with budesonide/ formoterol maintained control of their symptoms using significantly less medication overall than fixed dosing,” said Dr. FitzGerald. “Flexible maintenance dosing achieved guideline goals of effective asthma control at an appropriately low maintenance dose of medication. Moreover, patients were able to adjust their dose at the first sign of worsening to maintain asthma control, all without adding or switching inhalers.”