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Communications to the Editor |

Short-term Budesonide Dosage FREE TO VIEW

Hanneke J. van der Woude, MD; René Aalbers, MD, PhD
Author and Funding Information

Affiliations: Groningen, The Netherlands,  Servizio di Fisiopatologia Respiratoria Sesto Sau Giovanni, Italy

Correspondence to: H.J. van der Woude, MD, Martini Ziekenhuis, afdeling longziekten, Locatie van Swieten, Van Swietenlaan 4, Groningen, The Netherlands; e-mail: h.woude@mzh.nl



Chest. 2001;119(1):309-310. doi:10.1378/chest.119.1.309
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To the Editor:

We read with interest the study in CHEST by Foresi et al1 (February 2000),1 in which a randomized, double-blind, multicenter, parallel group-designed study was used to investigate the effect of a short-term increase in daily dosage of budesonide on the exacerbations of asthma. In this study, an exacerbation was defined by a fall in peak expiratory flow < 70% from baseline value, calculated during the last 2-week pretreatment period, on at least 2 consecutive days. Patients were randomized into three groups. Patients in group 2 and group 3 received the same daily dosage of budesonide, 100 μg bid. The patients randomly assigned to group 2 received an additional course of budesonide, 200 μg qid, in the event of an exacerbation, while patients in group 3 received a placebo. The daily dosage of budesonide was the same for group 2 and group 3, the only difference being the method of treatment for an exacerbation. This difference could become clear only after the first exacerbation.

In the preprotocol analysis, the difference in patients experiencing at least one exacerbation was significant (χ2; p < 0.025). Unfortunately, this meant that the patients were not well randomized, because the a priori change for experiencing at least one exacerbation was the same when patients had the same baseline characteristics and when they received the same daily doses of budesonide.

The effect of the increased daily dose of inhaled budesonide was measurable only after the first exacerbation, because the effect of the increased dose may then have become apparent. However, the difference between the two groups of patients experiencing two or more exacerbations was not large and therefore seemed insignificant.

Because the patients were not well randomized, we think it was impossible to make a comparison between the patients of group 2 and those of group 3 in the number of days with exacerbations.

Based on results of this study, we do not think it was justified to conclude that a short-term, increased daily dosage of budesonide had a beneficial clinical effect on the onset of an asthmatic exacerbation.

References

Foresi, A, Morelli, MC, Catena, E, et al (2000) Low-dose budesonide with the addition of an increased dose during exacerbations is effective in long-term asthma control.Chest117,440-446. [CrossRef] [PubMed]
 
To the Editor:

Dr. van der Woude and Dr. Aalbers suggest that the patients in our study were not well randomized, and they question our conclusion that a short-term increase in the dose of inhaled budesonide at the onset of an exacerbation has a beneficial effect for asthmatics. The study was conducted following a double-blind, randomized design. The three groups of asthmatics were well balanced as regards gender, age, smoking habit, duration of the disease, additional treatments, and baseline lung function parameters, as shown in Table 1 in the article. However, the sample size was chosen to compare the maintenance treatment regimens of budesonide 400 μg bid with 200 μg bid, plus additional treatment given whenever peak expiratory flow fell > 30% on two consecutive days. Although exacerbation is a common clinical feature of asthma and a daily problem for chest physicians, it has received very little attention until recently. So far, very few clinical studies have included the assessments of asthma exacerbations as primary or secondary outcomes. The reason is likely due to a lack of a widely accepted and validated definition for asthma exacerbation, which needs to be based on objective variables, and to its relative low rate of occurrence in patients treated with inhaled steroids. I cannot exclude the possibility that the difference in the number of exacerbations between groups 2 and 3 was due to random fluctuation. As we pointed out in our article, it is possible that the criteria for the presence of an exacerbation does not adequately reflect a truly deteriorating clinical condition. Indeed, the intention-to-treat analysis does not show any difference between the two groups. Although the power of the statistics on the number of exacerbations is probably weak, our results on the number of days with exacerbations and on the number of days during which patients required oral corticosteroids suggest, at least, that the control of asthma with low-dose budesonide, with increasing doses of budesonide during exacerbations, is similar to long-term treatment with standard budesonide dose. Although not conclusive, our results, taken together with those of others,15 strongly support the hypothesis that, for patients treated with inhaled steroids, clinical worsening of asthma could be controlled, at least in part, by increasing the dose of inhaled corticosteroids.6

References
Levy, ML, Stevenson, C, Maslen, T Comparison of short courses of oral prednisolone and fluticasone propionate in the treatment of adults with acute exacerbations of asthma in primary care.Thorax1996;51,1087-1092. [CrossRef] [PubMed]
 
Rodrigo, G, Rodrigo, C Inhaled flunisolide for acute severe asthma.Am J Respir Crit Care Med1998;157,698-703. [PubMed]
 
Nana, A, Youngchaiyud, P, Charoenratanakul, S, et al High-dose inhaled budesonide may substitute for oral therapy after an acute asthma attack.J Asthma1998;5,47-55
 
Volovitz, B, Bentur, L, Finkelstein, Y, et al Effectiveness and safety of inhaled corticosteroids in controlling acute asthma attacks in children who were treated in the emergency department: a controlled comparative study with oral prednisolone.J Allergy Clin Immunol1998;102,605-609. [CrossRef] [PubMed]
 
Matthews, EE, Curtis, PD, McLain, BI, et al Nebulized budesonide versus oral steroid in severe exacerbations of childhood asthma.Acta Paediatr1999;88,841-843. [CrossRef] [PubMed]
 
Ernst, P, Fitzgerald, JM, Spier, SS Canadian Asthma Consensus Conference. Summary of recommendations.Can Respir J1996;3,89-100
 

Figures

Tables

References

Foresi, A, Morelli, MC, Catena, E, et al (2000) Low-dose budesonide with the addition of an increased dose during exacerbations is effective in long-term asthma control.Chest117,440-446. [CrossRef] [PubMed]
 
Levy, ML, Stevenson, C, Maslen, T Comparison of short courses of oral prednisolone and fluticasone propionate in the treatment of adults with acute exacerbations of asthma in primary care.Thorax1996;51,1087-1092. [CrossRef] [PubMed]
 
Rodrigo, G, Rodrigo, C Inhaled flunisolide for acute severe asthma.Am J Respir Crit Care Med1998;157,698-703. [PubMed]
 
Nana, A, Youngchaiyud, P, Charoenratanakul, S, et al High-dose inhaled budesonide may substitute for oral therapy after an acute asthma attack.J Asthma1998;5,47-55
 
Volovitz, B, Bentur, L, Finkelstein, Y, et al Effectiveness and safety of inhaled corticosteroids in controlling acute asthma attacks in children who were treated in the emergency department: a controlled comparative study with oral prednisolone.J Allergy Clin Immunol1998;102,605-609. [CrossRef] [PubMed]
 
Matthews, EE, Curtis, PD, McLain, BI, et al Nebulized budesonide versus oral steroid in severe exacerbations of childhood asthma.Acta Paediatr1999;88,841-843. [CrossRef] [PubMed]
 
Ernst, P, Fitzgerald, JM, Spier, SS Canadian Asthma Consensus Conference. Summary of recommendations.Can Respir J1996;3,89-100
 
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