Source: Annual Congress 2002 - Asthma in primary care - Assessment and control
Disease area: Airway diseases

Abstract

Clinical studies in asthmatic patients have demonstrated that the new Salamol CFC-Free™ inhalers are therapeutically equivalent to the existing salbutamol CFC inhalers in terms of efficacy and safety. The purpose of the present study was to provide further evidence of safety and tolerability of Salamol CFC-Free™ metered dose inhaler (MDI) in a large patient population with asthma. 1009 adults and children were assigned to either Salmol CFC-Free™ or salbutamol CFC MDI in a 3:1 ratio. Patients were assessed at baseline and then at the termination visit (month 3). Details of asthma exacerbations, adverse events, hospital admissions and visits, withdrawals and change to concomitant asthma medication were recorded for the duration of the study. Overall no difference was seen in the incidence of adverse events between groups (30.6% patients on Salamol CFC-Free™ and 35.4% patients on salbutamol CFC). Over 90% of reported adverse events were mild, reversible and considered unrelated to study medication in either group. The number of patients withdrawn from the Salamol CFC-Free™ group was greater then the salbutamol CFC group (10.2% compared to 4.8% respectively). This observation was similar to that seen in the Ayres study (Ayres, J.G. et al. BMJ 1998; 317:926-30), whereby, because of the nature of the study, it may be influenced by subjective perceptions of the effects of a new medication. Further examination of the reasons for withdrawal did not reveal any safety-related problems.
These findings demonstrate no evidence of any new safety-related issues with the use of Salamol CFC-Free™ MDIs in general practice.

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Citations should be made in the following way:
E. Gooden, V. Perrin (London, United Kingdom). A post-marketing study to evaluate the safety and tolerability of a non-chlorofluorocarbon salbutamol inhaler in asthmatic patients in general practice. Eur Respir J 2002; 20: Suppl. 38, 585

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