• The primary outcome for comparison across treatment groups was the mean value of morning PEF measured during the last 2 weeks of treatment (weeks 23-24)
  

• Number of exacerbations
  
• Time to first severe exacerbation
  
• Improvement of asthma symptoms (symptom scores)
  
• Need for short acting b2 agonists
  
• Variation of respiratory parameters (FEV1, PEF, FVC, FEV1/FVC, FEF25-75) immediately before and 30 min after a test with a short-acting b2 agonist
  
• evening PEF
  
• Diurnal variability of PEF
  
• Nocturnal asthma (nocturnal awakening because of asthma)
  
• Nights and days without asthma symptoms (score 0)
  

Asthma is widely recognised as a chronic inflammatory disorder of the airways. The 1997 American National Heart Lung and Blood Institute (NHLBI) Guidelines states that a firm scientific basis exists to indicate that asthma results from complex interactions among inflammatory cells, mediators and the cells and tissues resident in the airways. Despite the existence of effective therapy people still die from asthma. It is pertinent to state that the clinical effect of a drug is not only dependent on the specific action of the drug, but also on the patient’s way of using it. Therefore, compliance is an important factor especially for chronic disorders such as asthma. Indeed, non compliance with asthma therapy is a serious problem. It has been reported that drug side effects, lifestyle, social and economic factors, method of drug delivery and dosing are factors that contribute to poor compliance. The consequences of poor compliance lead to increased morbidity due to increased symptoms and asthma exacerbation.

The NHLBI Guidelines recommend daily treatment for patients with mild persistent asthma with inhaled glucocorticoids (200-500mcg/die) and short-acting bronchodilators as needed but no more than 3-4 times a day. Comparisons: beclomethasone dipropionate 250 mg combined with salbutamol 100 mg “as needed”, vs salbutamol 100 mg alone “as needed”, vs beclomethasone 250 mg twice a day plus salbutamol 100 mg “as needed” and vs beclomethasone dipropionate 250 mg combined with salbutamol 100 mg twice a day plus salbutamol 100 mg “as needed”, in the treatment of patients with mild persistent asthma.