A 52-week, double-blind, randomised, multi-centre, parallel-group,Phase III study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort® (budesonide/formoterol) Turbuhaler® 160/4.5 µg ‘as needed’ compared with terbutaline Turbuhaler® 0.4 mg ‘as needed’ and with Pulmicort® (budesonide) Turbuhaler® 200 µg twice daily plus terbutaline Turbuhaler® 0.4 mg ‘as needed’

INTERVENTION: Trade Name: Symbicort Turbuhaler, 160 micrograms/4.5 micrograms/inhalation, inhalation powder Pharmaceutical Form: Inhalation powder INN or Proposed INN: BUDESONIDE CAS Number: 51333‐22‐3 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 160‐ INN or Proposed INN: Formoterol CAS Number: 43229‐80‐7 Other descriptive name: FORMOTEROL FUMARATE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 4.5‐ Trade Name: Bricanyl Turbuhaler, inhalation powder Product Name: Terbutaline Turbuhaler 0.4 mg/dose Pharmaceutical Form: Inhalation powder INN or Proposed INN: TERBUTALINE SULFATE CAS Number: 23031‐32‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.4‐ Trade Name: Pulmicort Turbuhaler, 200 micrograms/dose, inhalation powder Pharmaceutical Form: Inhalation powder INN or Proposed INN: BUDESONIDE CAS Number: 51333‐22‐3 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use CONDITION: Asthma Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: To demonstrate that Symbicort Turbuhaler 160/4.5 µg ‘as needed’ is superior to terbutaline Turbuhaler 0.4 mg ‘as needed’. Primary end point(s): Evaluation of asthma control as measured by well‐controlled asthma weeks as the primary variable Secondary Objective: 1.To evaluate the relative efficacy of Symbicort Turbuhaler 160/4.5 µg ‘as needed’ and Pulmicort Turbuhaler 200 µg twice daily plus terbutaline Turbuhaler 0.4 mg ‘as needed’.; 2.To evaluate the efficacy of Symbicort Turbuhaler 160/4.5 µg as compared to both:; terbutaline Turbuhaler 0.4 mg ‘as needed’; And:; Pulmicort Turbuhaler 200 µg twice daily plus terbutaline Turbuhaler 0.4 mg ‘as needed’.; Timepoint(s) of evaluation of this end point: well‐controlled asthma weeks, weekly, up to 52 weeks SECONDARY OUTCOME: Secondary end point(s): Time to first severe asthma exacerbation ; Time to first moderate or severe asthma exacerbation ; Average change from baseline in pre‐dose FEV1 ; Average change from baseline in Morning PEF ; Average change from baseline in Evening PEF ; Average change from baseline in number of inhalations of ‘as needed’ medication ; Average change from baseline in symptom score ; Percentage of Nighttime awakenings due to asthma ; Percentage of Symptom‐free days ; Percentage of ‘As needed’ free days ; Percentage of Asthma control days ; Time to asthma related discontinuation ; Poorly controlled asthma weeks ; Time to additional steroids for asthma ; Average change from baseline in Asthma Control Questionnaire (ACQ‐5) ; Average change from baseline in Asthma Quality of Life Questionnaire; standard version (AQLQ(S)) ; Timepoint(s) of evaluation of this end point: Time to first severe asthma exacerbation ; Time to first moderate or severe asthma exacerbation ; Average change from baseline in pre‐dose FEV1 ; Average change from baseline in Morning PEF ; Average change from baseline in Evening PEF ; Average change from baseline in number of inhalations of ‘as needed’ medication ; Average change from baseline in symptom score ; Percentage of Nighttime awakenings due to asthma ; Percentage of Symptom‐free days ; Percentage of ‘As needed’ free days ; Percentage of Asthma control days ; Time to asthma related discontinuation ; INCLUSION CRITERIA: 1.Provision of informed consent prior to any study specific procedures. For patients under‐age, signed informed consent from both the patient and the patient’s parent/legal guardian is required 2.Outpatients of either gender aged =12 years at Visit 1 3.Diagnosis of asthma according to GINA criteria with a documented history of at least 6 months prior to Visit 1 4.Patients who are in need for GINA step 2 treatment: ‐uncontrolled on SABA ‘as needed’ as judged by the investigator for the last 30 days before Visit 2, or ‐controlled on mono‐maintenance therapy with low stable dose ICS (= 400 µg budesonide per day or corresponding dose of other ICS, or LTRAs as judged by the investigator for the last 30 days prior to Visit 2 5.Based on lung function tests at Visit 2, patients pre‐treated with ‐a SABA only should have prebronchodilator FEV1 = 60 % of predicted normal (PN) and postbronchodilator FEV1 = 80 % PN according to the European Res