Budesonide/Formoterol in a Single Inhaler Shown to Enhance Asthma Control

Health Canada currently reviewing highly-anticipated product to address the variability of asthma

TORONTO, Ontario (October 3, 2001) – A significant new development in the field of asthma management means hope is on the horizon for Canada’s three million asthma sufferers, including almost 60 per cent who are inadequately controlled.¹

New data presented at the 11th Annual Congress of the European Respiratory Society (ERS) has shown that budesonide/formoterol in a single inhaler (Symbicort™ Turbuhaler^®)  – a new combination asthma therapy currently under review by Health Canada, but not yet available – improves control significantly more effectively than budesonide2, a current asthma treatment.

“Data from the ERS has shown that having budesonide and formoterol (a long-acting brochodilator) in the same inhaler to simultaneously treat underlying inflammation and bronchoconstriction – or tightening of the airways – is enabling doctors to quickly and effectively gain and maintain control of their patients' condition,” says Dr. Meyer Balter, Division of Respiratory Medicine, Mount Sinai Hospital in Toronto.  “When approved in Canada, budesonide/formoterol in a single inhaler will change the scope of asthma control, offering versatile dosing and better patient adherence,” he explained.

Beyond the improved convenience of having two effective treatments in one single inhaler, budesonide/formoterol in a single inhaler is a maintenance therapy that gains control quickly.  By providing patients with greater confidence in their treatment, budesonide/formoterol in a single inhaler will help to reinforce good adherence to a patient’s asthma therapy.  “Budesonide/formoterol in a single inhaler will benefit not just those asthma patients inadequately controlled on inhaled corticosteroid therapy and who need a long-acting bronchodilator, but also those patients who are already taking these two treatments as separate inhalers,” explained Dr. Balter.

Budesonide/formoterol in a single inhaler contains two key components of asthma therapy: the inhaled corticosteroid budesonide (Pulmicort^®)³ and the fast and long-acting beta-agonist bronchodilator formoterol (Oxeze^®)^4,5.

The unique characteristics of these components allow dosing with the same single inhaler to be stepped up and down according to the changing severity of the patient’s asthma.  In countries where budesonide/formoterol in a single inhaler is approved, the dosing range allows maintenance treatment to be tailored according to the patient’s symptoms using the same single inhaler.

Total asthma control significantly improved by budesonide/formoterol in a single inhaler

One study, presented at ERS, measured control of asthma in terms of Total Asthma Control Week (TACW), defined as a week with no symptoms, no awakenings and reliever use less than or equal to four inhalations/week for less than or equal to two days.  Compared with budesonide treatment alone, budesonide/formoterol in a single inhaler increased the chance of achieving a TACW in adults with moderate persistent asthma by 78 per cent in weeks one through four (p<0.05) and by 90 per cent in weeks one through 12 (p<0.05).²

Compared with budesonide treatment alone, budesonide and formoterol given as separate inhalers increased the chance of achieving a TACW by 37 per cent in weeks one through four (ns) and 79 per cent in weeks one through 12 (p=0.01).²

“Any treatment that helps doctors encourage patients to be more in control of their asthma is a welcome advance,” said Dr. Balter.  “Because budesonide/formoterol in a single inhaler is maintenance therapy that gains control quickly, it should provide patients with greater confidence in their treatment and thus help to reinforce good adherence to their asthma therapy.”

Once-daily therapy with budesonide/formoterol in a single inhaler maintains control

In a second study, presented at the ERS, once-daily treatment in mild-to-moderate persistent asthma with budesonide/formoterol in a single inhaler has been shown to improve and maintain asthma control at least as effectively as the equivalent total daily dose of budesonide/formoterol in a single inhaler, administered twice-daily in the morning and evening.⁶ In addition, once-daily treatment with budesonide/formoterol in a single inhaler proved to be significantly more effective than once-daily budesonide.⁷

“For patients who are well controlled on one inhalation twice daily, budesonide/formoterol in a single inhaler provides the option to take the total daily dose once a day.  This is an important benefit as it may be more convenient for patients and lead to improved adherence to treatment,” explained Dr. Balter.

A third study using low-dose budesonide/formoterol in a single inhaler, showed that a once-daily regimen is equivalent in efficacy to twice-daily dosing in the long-term maintenance of adults with stable mild persistent asthma, and significantly more effective than budesonide alone.⁸

About AstraZeneca

AstraZeneca is one of the world's leading pharmaceutical companies with a formidable product portfolio spanning seven major therapeutic areas: cardiovascular, gastrointestinal, oncology, pain control, respiratory, central nervous system and infection.  AstraZeneca's brands include Atacand^®, Losec^®, Nexium^® , Oxeze^® Turbuhaler^®, Merrem^®, Arimidex^®, Diprivan^®, Pulmicort^® Turbuhaler^®, Zomig^® and Seroquel^®.  The Canadian headquarters and manufacturing facilities of AstraZeneca are located in Mississauga, Ontario, with a state-of-the-art basic research centre based in Montréal, Québec.

For further information regarding asthma and budesonide/formoterol in a single inhaler, please visit www.Symbicort-Newscentre.com.

References:

1. Asthma in Canada: A Landmark Survey, 2000.
2. Buhl R et al. Improved asthma control with budesonide/formoterol via a single inhaler, compared to budesonide alone, in moderate persistent asthma. Abstract No P414 at European Respiratory Society Annual Congress, Berlin, 22-26 September, 2001.
3. Pulmicort^® Turbuhaler^® Product Monograph
4. Ringdal N, Derom E, Wåhlin-Boll E, et al. Onset and duration of action of single doses of formoterol inhaled via Turbuhaler^®. Respir Med 1998; 92: 1017-1021.
5. Oxeze^® Turbuhaler^® Product Monograph
6. Buhl R et al. Once-daily budesonide/formoterol via a single inhaler is effective in mild-to-moderate persistent asthma. Abstract No 259, at European Respiratory Society Annual Congress, Berlin, 22-26 September, 2001
7. Buhl R et al. Improved and maintained asthma control with once-daily budesonide/formoterol single inhaler therapy in mild-to-moderate persistent asthma. Abstract No 260 at European Respiratory Society Annual Congress, 22-26 September, 2001
8. Kuna P et al. Low-dose single-inhaler budesonide/formoterol administered once daily is effective in mild-persistent asthma. Abstract No P1071 at European Respiratory Society Annual Congress, Berlin, 22-26 September, 2001.