Budesonide Inhalation Powder for Asthma

By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD

The swedish drug giant astra has received fda approval to market budesonide, an inhaled corticosteroid, under the name of Pulmicort Turbohaler. Budesonide is formulated as a dry powder inhalation driven delivery system that is not dependent on chlorofluorocarbon propellant (CFCs). Pulmicort is currently widely used in Europe and Canada for asthma.

Indications

Budesonide is indicated for the maintenance treatment of asthma and as prophylactic treatment in adult and pediatric patients 6 years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma.

Dosing Information

Budesonide as Pulmicort is supplied as a dry powder inhalant, with each dose delivering 200 mcg (160 mcg from the mouth piece). Each canister supplies approximately 200 doses. Adults on bronchodilators alone should start 200-400 mcg twice daily. Adults on inhaled steroids should start 200-400 mcg twice daily but may increase it to a maximum recommended dose of 800 mcg twice daily. For adults on oral steroids, the recommended starting dose is 400-800 mcg twice daily (maximum recommended dose is 800 mcg twice daily).

The recommended starting dose in children is 200 mcg twice daily, with the highest recommended dose being 400 mcg twice daily.1

Potential Advantages

Compared with fluticasone, budesonide has a shorter elimination half life, lower lipophilicity, greater glucocorticoid receptor potency, and greater receptor residence time, which may result in less adrenal suppression. These findings were suggested in several studies when comparable doses and delivery devices of fluticasone and budesonide were compared.2-6 Budesonide is available as a dry powder in an inhalation driven device. This obviates the need for good inhalation technique and the use of a spacer. This may also result in less variation in deposition of drug in the lungs. Recently, it was reported that the Turbohaler was more cost effective than a metered dose inhaler (generally without a spacer) as measured by the number of exacerbations and resultant hospitalizations.7 (Recently, fluticasone propionate as a dry powder [Diskhaler] has been approved by the FDA.)

Potential Disadvantages

Ketoconazole may increase the plasma levels of budesonide by inhibiting cytochrome P450 3A isoenzymes.1 Budesonide Turbohaler is available in only one strength, which limits dosing flexibility for age and disease severity, providing median dose and high dose only. The most common side effects include hoarseness, sore throat, dysphonia, oral candidiasis, and cough.1

Comments

Budesonide is a corticosteroid with a high ratio of topical to systemic activity.8 It was recently approved for marketing and is expected to be available in an inspiratory flow-driven dry powder in January 1998. Budesonide appears to be 1.5-1.67 times more potent than beclomethasone and similar in potency to fluticasone on a mcg for mcg basis.9-11

Clinical Implications

Inhaled steroids are considered first-line anti-inflammatory treatment of asthma, providing the most potent and effective anti-inflammatory therapy currently available for persistent asthma.11 Budesonide provides a potent steroid with a different delivery system that offers ease of use and provides an efficient delivery of drug to the airways.12 Budesonide is cost competitive to other inhaled anti-inflammatory agents.

References

1. Pulmicort Turbohaler Product Information. Astra. June 1997.

2. Grahnen A, et al. Eur J Clin Pharmacol 1997;52:261-267.

3. Boorsma M, et al. Eur Respir J 1996;9:1427-1432.

4. Clark DJ, et al. Thorax 1997;52:55-558.

5. Clark DJ, et al. Thorax 1996;51:262-266.

6. Grahnen A, et al. Br J Clin Pharmacol 1995;38:521-525.

7. Liljas B, et al. Pharmacoeconomics 1997;12:267-277.

8. Brogden RN, et al. Drugs 1992;44(3):375-407.

9. Selroos O, et al. Allergy 1994;49:833-836.

10. Brambilla C, et al. Drug Invest 1994;8:49-56.

11. NHLBI. Guidelines for the Diagnosis and Management of Asthma. February 1997.

12. Thorsson L, et al. Eur Respir J 1994;7:1839-1844.

Gemfibrozil treatment of post-CABG patients with isolated low HDL has been associated with marked reduction in subsequent clinical events despite lack of any demonstrated angiographic benefit.

The most common side effects of budesonide include all of the following except:

a. headache.

b. dysphonia.

c. hoarseness.

d. sore throat.