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Therapeutics

Once-daily beclomethasone was effective for moderate asthma

ACP J Club. 1994 Nov-Dec;121:71. doi:10.7326/ACPJC-1994-121-3-071

Related Content in the Archives
• Correction: Once-daily beclomethasone was effective for moderate asthma


Source Citation

Gagnon M, Côté J, Milot J, Turcotte H, Boulet LP. Comparative safety and efficacy of single or twice daily administration of inhaled beclomethasone in moderate asthma. Chest. 1994 Jun;105:1732-7.


Abstract

Objective

To compare the short-term effectiveness of once-daily with twice-daily inhaled beclomethasone dipropionate in adults with moderate asthma.

Design

14-week, randomized, double-blind, crossover trial.

Setting

A Canadian tertiary care asthma clinic.

Patients

42 patients (mean age 39 y, 55% men) with moderate asthma using the American Thoracic Society definition confirmed by spirometric criteria. Inclusion criteria were a need for at least 1000 µg of beclomethasone or 800 µg of budesonide for optimal control of asthma, an FEV1 > 60% of predicted while being treated with inhaled steroids, no increase in respiratory symptoms or medication in the previous 4 weeks, and no symptomatic exposure to allergens or a respiratory infection in the previous month.

Intervention

After a 2-week evaluation period, patients were allocated to each of three, 4-week beclomethasone regimens, the order being determined by random allocation: regimen A, morning and bedtime dose of 500 µg; regimen B, 1000 µg in the late afternoon; and regimen C, 1000 µg at bedtime. Blinding was maintained using 4 metered-dose inhalers daily. Patients used albuterol inhalers as needed for symptom control. Follow-up was 88%.

Main outcome measures

Pulmonary function tests, responsiveness to methacholine, and self-reported daytime and nighttime asthma symptoms (cough, chest tightness, sputum, wheezing, and dyspnea) graded on a 10-point scale.

Main results

4 patients withdrew because of exacerbation: 1 during baseline, 1 during the twice-daily regimen, and 2 during the afternoon single-dose regimen. The values of the major outcomes for regimens A, B, and C were as follows: albuterol use, 3.3, 3.1, and 3.3 puffs/d; mean daytime respiratory symptoms, 0.3, 0.22, and 0.28; FEV1, 85%, 84%, and 84% predicted; and peak expiratory flow rates (morning/evening), 451/454, 441/459, and 447/452 L/min, respectively. None of the differences approached conventional levels of statistical significance. Side effects were minimal, and cortisol levels and response to adrenocorticotropic hormone remained normal throughout the study period.

Conclusion

Single- and twice-daily administration of beclomethasone were equally effective for short-term control of symptoms of moderate asthma.

Source of funding: Glaxo, Canada.

For article reprint: Dr. L-P. Boulet, Unité de Recherche, Centre de Pneumologie de L'Hôpital Laval, Sainte Foy, Quebec, Canada. FAX 418-656-4762.


Commentary

Inhaled corticosteroids offer the benefits of oral corticosteroids with a more favorable side effect profile (1-3). 3 aerosol corticosteroids are currently available in the United States: beclomethasone, flunisolide, and triamcinolone. All are effective for asthma management; however, much of the published data on efficacy and safety are from studies of beclomethasone. Because the primary therapeutic aim in asthma management is to decrease airway hyper-responsiveness, greater use of inhaled corticosteroids, which are very effective in achieving this goal, has been encouraged (1). Adherence to a regimen stipulating regular medication use on a 3-to-4 times/d schedule is poor (2). Consequently, studies indicating that an inhaled corticosteroid was equally effective when used once daily are of considerable importance because these regimens are likely to promote higher rates of adherence.

The study by Gagnon and colleagues shows that a similar level of asthma control was achieved with once-daily compared with twice-daily administration of inhaled corticosteroid. It is important to note, however, that patients received relatively high-dose (1000 µg/d) beclomethasone regimens (3, 4). Beclomethasone inhalers containing 250 µg per puff have been used in the United Kingdom since 1974 (4). Beclomethasone inhalers currently available in the United States, however, deliver only 42 µg per puff; hence, 24 puffs of beclomethasone would be required to achieve drug delivery equivalent to the regimen used in this investigation.

Persons with stable, moderate asthma were studied for 14 weeks. Therefore, these findings cannot be extended to persons with severe or moderate-to-severe asthma, or persons with unstable asthma. The latter point is important in view of the capricious nature of asthma and the reduced efficacy of less frequent inhaled corticosteroid dosing in the setting of asthmatic relapse (2). Further investigation is required before a once-daily dosing schedule for long-term inhaled corticosteroid use can be recommended.

David Lang, MD
Hahnemann UniversityPhiladelphia, Pennsylvania, USA


References

1. National Heart, Lung, and Blood Institute. Guidelines for the diagnosis and management of asthma. Bethesda MD: U.S. Department of Health and Human Services, 1991. Publication No. 91-3042.

2. Smith MJ, Hodson ME. High-dose beclomethasone inhaler in the treatment of asthma. Lancet. 1983;1:265-9.

3. Wright EC. Non-compliance—or how many aunts has Matilda? Lancet. 1993;342:909-13.

4. Toogood JH, Baskerville JC, Jennings B, Lefcoe NM, Johansson SA. Influence of dosing frequency and schedule on the response of chronic asthmatics to the aerosol steroid, budesonide. J Allergy Clin Immunol. 1982;70:288-98.