Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms

Inclusion Criteria: Patients will be enrolled into the 2-week placebo run-in period if they meet all the following criteria: * Age ≥ 1 year and ≤ 4 years. * At least 3 episodes of wheeze or asthma-like symptoms in the 6 months preceding the study entry. * A cooperative attitude and ability to be trained to inhale correctly from the device and to complete the diary cards. * Written parental/guardian informed consent obtained. Patients will be then randomised to the treatment period if they meet all the previous criteria plus: * Presence in at least 7 days out of the 14 days of the run-in period of at least one of the following symptoms: wheeze, cough or shortness of breath; or had required at least one dose of relief salbutamol. Exclusion Criteria: * History of severe asthma exacerbation or exacerbations requiring hospitalisation in the previous 4 weeks. * Symptomatic infection of the airways requiring treatment with antibiotics or antimycotics in the previous 4 weeks. * Treatment with inhaled steroids in the previous 4 weeks or oral steroids in the previous 8 weeks. * Treatment with methyl-xantine derivatives in the previous 4 weeks. * Treatment with long-acting β2-agonists in the previous 2 weeks. * Changes in asthma medications taken on regular basis in the previous 4 weeks. * Symptoms of asthma limited to seasonal allergen exposure. * History of clinically significant cardiac, renal, neurologic, hepatic, endocrine or pulmonary disease (except asthma), or laboratory testing abnormalities, whose sequelae and/or treatments can interfere with the results of the present study. * Evidence of pulmonary malformations. * Evidence of immunological deficiency (patients to be withdrawn if diagnosed during the study). * Cancer or any other chronic disease with prognosis \< 2 years. * Hypersensitivity to inhaled corticosteroids. * Participation in another trial in the last 4 weeks.