Journal Article

Combination of budesonide/formoterol on demand improves asthma control by reducing exercise-induced bronchoconstriction

Lazarinis, Nikolaos, Pullerits, Teet, Hedlin, Gunilla, Carlsen, Kai-Håkon, Larsson, Kjell, Ekström, Tommy, Dahlén, Barbro, Jørgensen, Leif, Bjermer, Leif

2014

Overview

Background In mild asthma exercise-induced bronchoconstriction (EIB) is usually treated with inhaled short-acting β2 agonists (SABAs) on demand. Objective The hypothesis was that a combination of budesonide and formoterol on demand diminishes EIB equally to regular inhalation of budesonide and is more effective than terbutaline inhaled on demand. Methods Sixty-six patients with asthma (>12 years of age) with verified EIB were randomised to terbutaline (0.5 mg) on demand, regular budesonide (400 μg) and terbutaline (0.5 mg) on demand, or a combination of budesonide (200 μg)  + formoterol (6 μg) on demand in a 6-week, double-blind, parallel-group study (ClinicalTrials.gov identifier: NCT00989833). The patients were instructed to perform three to four working sessions per week. The main outcome was EIB 24 h after the last dosing of study medication. Results After 6 weeks of treatment with regular budesonide or budesonide+formoterol on demand the maximum post-exercise forced expiratory volume in 1 s fall, 24 h after the last medication, was 6.6% (mean; 95% CI −10.3 to −3.0) and 5.4% (−8.9 to −1.8) smaller, respectively. This effect was superior to inhalation of terbutaline on demand (+1.5%; −2.1 to +5.1). The total budesonide dose was approximately 2.5 times lower in the budesonide+formoterol group than in the regular budesonide group. The need for extra medication was similar in the three groups. Conclusions The combination of budesonide and formoterol on demand improves asthma control by reducing EIB in the same order of magnitude as regular budesonide treatment despite a substantially lower total steroid dose. Both these treatments were superior to terbutaline on demand, which did not alter the bronchial response to exercise. The results question the recommendation of prescribing SABAs as the only treatment for EIB in mild asthma.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Administration, Inhalation / Adolescent / Adrenergic beta-2 Receptor Agonists - administration & dosage / Adrenergic beta-2 Receptor Agonists - adverse effects / Adrenergic beta-2 Receptor Agonists - therapeutic use / Adult / Asthma / Asthma, Exercise-Induced - physiopathology / Asthma, Exercise-Induced - prevention & control / Bronchodilator Agents - administration & dosage / Bronchodilator Agents - adverse effects / Bronchodilator Agents - therapeutic use / Budesonide - administration & dosage / Budesonide - adverse effects / Budesonide - therapeutic use / Clinical Medicine / Double-Blind Method / Drug Administration Schedule / Drug Therapy, Combination / Ethanolamines - administration & dosage / Ethanolamines - adverse effects / Ethanolamines - therapeutic use / Exercise / Exercise Test - methods / Female / Fitness equipment / Forced Expiratory Volume - drug effects / Formoterol Fumarate / Glucocorticoids - administration & dosage / Glucocorticoids - adverse effects / Glucocorticoids - therapeutic use / Humans / Klinisk medicin / Lungmedicin och allergi / Male / Medical and Health Sciences / Medicin och hälsovetenskap / Respiratory Medicine and Allergy / Steroids / Terbutaline - administration & dosage / Terbutaline - adverse effects / Terbutaline - therapeutic use / Vital Capacity - drug effects / Young Adult