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Effect of formoterol with or without budesonide in repeated low-dose allergen challenge

¹ Division of Respiratory Medicine and Allergy, Dept of Medicine, Karolinska University Hospital Huddinge, ² Centre for Allergy Research, Karolinska Institutet, ⁵ Division of Physiology, The National Institute of Environmental Medicine, Karolinska Institutet, ³ Cityakuten, Stockholm, and ⁴ AstraZeneca Sweden, Södertälje, Sweden.

CORRESPONDENCE: B. Dahlén, , Lung and Allergy Clinic, M 53, Karolinska University Hospital Huddinge, SE-141 86 Stockholm, Sweden. Fax: 46 87117306. E-mail: barbro.dahlen{at}ki.se

Keywords: Airway hyperresponsiveness, allergic asthma, bronchoprovocation, exhaled nitric oxide, inhaled corticosteroids, long-acting β-agonists

Received: June 24, 2008
Accepted November 23, 2008

The use of combination therapy in mild asthma is debated. The current authors evaluated the effects of formoterol alone and a formoterol/budesonide combination inhaler on asthma deterioration induced by repeated low-dose allergen exposure.

In total, 15 subjects with intermittent allergic asthma inhaled low doses of allergen on seven consecutive weekdays in a three-period, crossover, double-blind, double-dummy comparison between formoterol 4.5 µg Turbuhaler^TM, budesonide 160 µg/formoterol 4.5 µg Turbuhaler^TM and placebo, each taken as two puffs 30 min after allergen dosing. The outcome variables were: provocative dose of methacholine causing a 20% fall in forced expiratory volume in one second (PD₂₀), exhaled nitric oxide fraction (F_eNO), sputum eosinophils and prostaglandin D₂, and diary card recordings of symptoms (on a scale of 0–10), short-acting β₂-agonist use and evening forced expiratory volume in one second (FEV₁).

With placebo treatment, allergen exposure caused significant increases in airway hyperresponsiveness (geometric mean (coefficient of variation) PD₂₀: 397 (98) µg before versus 168 (82) µg after), F_eNO (mean±SD 46±31 ppb before versus 73±46 ppb after) and asthma symptom score (mean±SD 0.39±0.55 before versus 0.68±0.67 after). Budesonide/formoterol abolished these changes and significantly improved baseline FEV₁. Formoterol alone, while providing symptom relief, was no better than placebo in protecting against the allergen-induced increase in airway inflammation.

Signs of deteriorating asthma, provoked by low-dose allergen, are prevented by short-term use of budesonide/formoterol but not by temporary use of formoterol alone.