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Combination of budesonide/formoterol on demand improves asthma control by reducing exercise-induced bronchoconstriction
  1. Nikolaos Lazarinis1,
  2. Leif Jørgensen2,
  3. Tommy Ekström2,
  4. Leif Bjermer3,
  5. Barbro Dahlén1,
  6. Teet Pullerits4,
  7. Gunilla Hedlin5,
  8. Kai-Håkon Carlsen6,
  9. Kjell Larsson7
  1. 1Division of Respiratory Medicine and Allergy, Department of Medicine, Karolinska University Hospital Huddinge, Karolinska Institutet, Stockholm, Sweden
  2. 2AstraZeneca Nordic, Södertälje, Stockholm, Sweden
  3. 3Department of Respiratory Medicine & Allergology, Lund University Hospital, Lund, Sweden
  4. 4Department of Respiratory Medicine and Allergology, Sahlgrenska University Hospital, Göteborg, Sweden
  5. 5Astrid Lindgren's Children's Hospital, Karolinska University Hospital Solna, Stockholm, Sweden
  6. 6Department of Paediatrics, Norwegian School of Sports Sciences, University of Oslo, Oslo University Hospital, Oslo, Norway
  7. 7Unit of Lung and Allergy Research, The National Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
  1. Correspondence to Dr Nikolaos Lazarinis, Division of Respiratory Medicine and Allergy, Department of Medicine, Karolinska University Hospital Huddinge, Stockholm 14186, Sweden; nikolaos.lazarinis{at}


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 ( 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.

  • Asthma
  • Exercise

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