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Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial
Alberto Papi1, Gabriele Nicolini, Nunzio Crimi
1Research Center on Asthma and COPD, University of Ferrara, Via Savonarola 9, 44100, Ferrara, Italy. ppa@unife.it
Respiratory Research
|June 27, 2012
Summary
Reducing inhaled corticosteroid/long-acting β2 agonist therapy in controlled asthma maintains lung function and control. Stepping down therapy is safe and effective for asthma management.
Area of Science:
- Pulmonology
- Clinical Pharmacology
Background:
- Asthma guidelines recommend reducing therapy once controlled, but this is rarely practiced.
- Uncertainty exists regarding optimal methods for stepping down asthma treatment.
- This study investigated stepping down high-dose inhaled corticosteroid/long-acting β2 agonist therapy.
Purpose of the Study:
- To evaluate lung function and asthma control in patients stepped down from high-dose inhaled corticosteroid/long-acting β2 agonist therapy.
- To compare two different stepping-down regimens.
Main Methods:
- Prospective, randomized, controlled, two-arm parallel group study.
- Adults with controlled asthma on high-dose fluticasone/salmeterol (1000/100 μg) were randomized to 6 months of either 500/100 μg fluticasone/salmeterol or 400/24 μg extrafine beclomethasone/formoterol.
- Primary outcome: change in morning peak expiratory flow (PEF); secondary outcomes: asthma control and exacerbation frequency.
Main Results:
- Lung function (PEF, FEV1) and asthma control were maintained in both groups.
- PEF remained above 95% of predicted values throughout the study.
- Asthma control was maintained in 95.2% of patients at 6 months, with no significant differences between treatment groups.
Conclusions:
- Stepping down high-dose fluticasone/salmeterol to lower doses of either fluticasone/salmeterol or extrafine beclomethasone/formoterol maintains lung function and asthma control.
- These findings support the clinical practice of reducing asthma therapy in controlled patients.
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