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Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial

Alberto Papi1*, Gabriele Nicolini2, Nunzio Crimi3, Leonardo Fabbri4, Dario Olivieri5, Andrea Rossi6 and Pierluigi Paggiaro7

Author Affiliations

1 Research Center on Asthma and COPD, University of Ferrara, Via Savonarola 9, 44100, Ferrara, Italy

2 Medical Affairs Department, Chiesi Farmaceutici, Parma, Italy

3 Department of Internal and Specialistic Medicine, Section of Respiratory Diseases, University of Catania, Catania, Italy

4 Section of Respiratory Diseases, University of Modena, Modena, Italy

5 Department of Clinical Sciences, University of Parma, Parma, Italy

6 Pulmonary Unit, University/General Hospital of Verona, Verona, Italy

7 Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy

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Respiratory Research 2012, 13:54  doi:10.1186/1465-9921-13-54

Published: 25 June 2012

Abstract

Background

Asthma guidelines suggest that therapy can be reduced once asthma is controlled. Despite these recommendations, asthmatic patients are seldom stepped down in clinical practice, and questions remain about when and how to reduce asthma therapy. The purpose of the present study was to evaluate lung function and asthma control in patients who were stepped down from the highest recommended dose of inhaled corticosteroid/long acting β2 agonist combination therapy.

Methods

This was a prospective, randomised, controlled, two-arm parallel group study. Asthmatic patients who were fully controlled with a high daily dose (1000/100 μg) of fluticasone/salmeterol were randomly assigned to 6 months of open-label treatment with either 500/100 μg fluticasone/salmeterol Diskus daily or 400/24 μg extrafine beclomethasone/formoterol pMDI daily. The primary outcome was the change in morning peak expiratory flow (PEF) values between baseline and the end of treatment. The secondary outcomes included asthma control and exacerbation frequency.

Results

Four hundred twenty-two patients were included in the analysis. The PEF values remained above 95% of the predicted values throughout the study. The end-study morning PEF rates showed equivalence between the groups (difference between means, 2.49 L/min; 95% CI, -13.43 to 18.42). No changes from baseline were detected in PEF and forced expiratory volume in 1 second measured at the clinics, in the symptom scores or in the use of rescue medication. Asthma control was maintained in 95.2% of the patients at 6 months. No significant differences between the groups were detected in any other parameter, including exacerbation frequency and adverse events.

Conclusions

Stepping down patients whose asthma is controlled with the highest recommended dose of fluticasone/salmeterol to either 500/100 μg fluticasone/salmeterol daily or 400/24 μg extra-fine beclomethasone/formoterol daily provides comparable maintenance of lung function and asthma control.

Trial registration

clinicaltrials.gov NCT00497237

Keywords:
Beclomethasone; Extrafine; Fluticasone; Formoterol; Salmeterol