A comperative, placebo-controlled, doubleblind, double dummy, cross over, single center phase IIIb study between formoterol alone and the fixed combination of formoterol and budesonide on airway responsiveness and airway inflammation induced by repeated low-dose allergen challenge.

INTERVENTION: Trade Name: Symbicort Turbuhaler Product Name: Symbicort Turbuhaler Pharmaceutical Form: Inhalation powder INN or Proposed INN: Formoterol/Budesonide Concentration unit: µg microgram(s) Concentration number: 4.5/160‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Trade Name: Oxis Turbuhaler Product Name: Oxis Turbuhaler Pharmaceutical Form: Inhalation powder INN or Proposed INN: formoterol Concentration unit: µg microgram(s) Concentration number: 4.5‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use CONDITION: Patient with stable and mild allergic asthma. PRIMARY OUTCOME: Main Objective: To compare the effects of formoterol alone (Oxis® Turbuhaler®) and the fixed combination of formoterol and budesonide (Symbicort® Turbuhaler®) on airway responsiveness as a marker of inflammation, induced by repeated lowdose allergen challange in allergic patients with mild asthma. Primary end point(s): To assess the effects of formoterol alone (Oxis®) compared to the fixed combination of formoterol and budesonide (Symbicort®) on airway responsiveness, induced by repeated low‐dose allergen challenge in allergic patients with mild asthma by assessment of the change in cumulative provocation dose of methacholine causing a 20% decrease in FEV1 (PD20 methacholine). This outcome variable, change in PD20 methacholine, will determin if the primary objective of the study is fulfilled. Secondary Objective: To compare the effects of the three treatments on symptoms and lung function, eNO and to assess the effect of repeated low‐dose exposure on markers of inflammation in blood and sputum. INCLUSION CRITERIA: 1.Provision of written informed consent 2.Female or Male, 18‐55 years old. A diagnosed history of asthma for at least 6 months and with at least one of the following: a) response to standard asthma treatment b)episodic wheezing c) change in lung function over short periods of time 3.Mild and stable asthma, only using b2‐agonists as needed for the last 4 weeks 4.A FEV1>80% of predicted normal value (postbronchodilator value). 5.Skin prick test positive to pollen, animal dander or house dust mite. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range