Chest
Volume 117, Issue 2, February 2000, Pages 440-446
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Low-Dose Budesonide With the Addition of an Increased Dose During Exacerbations Is Effective in Long-term Asthma Control

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Objectives

This study was designed to compare the effects of a 6-month treatment with budesonide 100 μg bid (low dose) and 400 μg bid (standard reference dose) in controlling symptoms and lung function in a group of asthmatics with moderate asthma (baseline FEV1 ≥ 50% and ≤ 90% of predicted values) previously treated with inhaled beclomethasone dipropionate (500 to 1,000 μg/d). Moreover, we investigated whether or not asthma exacerbations could be treated by a short-term increase in the daily dose of budesonide.

Methods

After a 2-week run-in period and 1-month treatment with a high dose of budesonide (800μ g bid), 213 patients with moderate asthma were assigned to randomized treatments. Daily treatment included budesonide (bid) plus an additional treatment in case of exacerbation (qid for 7 days). Treatments were as follows: budesonide 400 μg plus placebo (group 1); budesonide 100 μg plus budesonide 200 μg (group 2); and budesonide 100 μg plus placebo (group 3). Symptoms and a peak expiratory flow (PEF) diary were recorded and lung function was measured each month. An exacerbation was defined as a decrease in PEF > 30% below baseline values on 2 consecutive days.

Results

We found that that 1-month treatment with a high budesonide dose remarkably reduced all asthma symptoms. Moreover, symptoms were under control in all treatment groups throughout the study period. Similarly, lung function improved and remained stable, and no relevant differences between groups were observed. In each treatment group, the majority of patients had no exacerbations. In patients treated with the standard budesonide dose (group 1), the number of exacerbations and days with exacerbations were significantly lower than in group 3 (intention-to-treat analysis). Additionally, patients treated with low budesonide dose plus budesonide (group 2) experienced a significantly lower number of exacerbations and days with exacerbations compared to group 3 (per-protocol analysis).

Conclusions

This study demonstrates that when patients with moderate asthma had reached a stable clinical condition with a high dose of budesonide, a low dose of budesonide (200 μg/d) is as effective as the standard dose (800 μg/d) in the control of symptoms and lung function over a period of several months. Furthermore, results showed that the addition of inhaled budesonide (800 μg/d) at onset of an asthmatic exacerbation has a beneficial clinical effect.

Section snippets

Population

We recruited 220 adult patients with perennial asthma from 14 outpatient clinics. All patients had documented histories of asthma as defined by the American Thoracic Society.15 Patients following an established treatment with inhaled beclomethasone dipropionate (500 to 1,000 μg/d) for at least 4 weeks were selected if they fulfilled the following inclusion criteria: (1) age between 18 and 65 years; (2) baseline FEV1 ≥ 50% and≤ 90% of predicted values;16 (3) daily peak expiratory flow (PEF)

Population

A group of 220 asthmatic patients were enrolled. Seven patients were withdrawn during the run-in phase and four patients just after randomization. Thus, the intention-to-treat analysis was based on 209 patients. Their characteristics are shown in Table 1. Only 16 patients were current smokers. A group of 22 patients discontinued their treatment: 10 patients were lost at follow-up, 4 patients for adverse events and 8 patients for other reasons. Therefore, out of 213 randomized patients, a group

Discussion

The results of the present study demonstrate that asthmatic patients with respiratory symptoms are kept under control and lung function is stabilized after a short-term treatment with a high dose of inhaled budesonide followed by a long-term treatment with either a standard dose (400 μg bid) of budesonide or a low dose (100 μg bid) of budesonide. This clinical effect is evident for up to a period of 6 months. Moreover, this study suggests that clinical exacerbations of asthma are effectively

Appendix

The Italian Study Group includes the following: Prof. Francesco Bariffi, Cattedra Malattie App. Respiratorio, II Facoltà di Medicina Ospedale Monaldi, Università di Napoli; Prof. Alberto Bisetti, 1a Clinica Tisiologica Università La Sapienza Ospedale Forlanini, Roma; Dr. Fernando De Benedetto, Divisione di Pneumologia, Presidio Ospedaliero S. Camillo de Lellis, Chieti; Dr. Enrico Farina, Divisione di Pneumologia, Ospedale Civile, L'Aquila; Prof. Francesco Ginesu, Clinica Malattie dell'Apparato

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    This study was supported by a grant from Astra Farmaceutici, S.p.A., Italy.

    A complete list of participants is located in the Appendix.

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