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Ventolin Evohaler study

A summary of the Ventolin Evohaler study written in lay language for interested patients.

Background

Until recently, most inhalers used to treat asthma contained a propellant (a chemical substance that helps to create the fine spray that is breathed in) made of chloroflurocarbons (CFCs). Since CFCs are now being phased out worldwide because of their adverse effects on the environment, it has been necessary to develop other propellants. Salbutamol (Ventolin®) is a medicine that is very widely used in the treatment of asthma symptoms. When Ventolin® is breathed (inhaled), the air passageways in the lung become wider, making it easier to breathe. A new type of Ventolin® inhaler containing a hydrofluoroalkane (HFA) propellant (known as the Ventolin Evohaler®) has been developed and tested in clinical trials. The purpose of this study was to monitor the safety of the Ventolin Evohaler® during its introduction into use in general practice in England.

Method

Between October 1998 and December 1999, General Practitioners (GPs) sent information on medical events occurring in regular users of Ventolin® to the Drug Safety Research Unit (DSRU). During that period many patients were transferred from standard Ventolin® to the Ventolin Evohaler®. A medical event is defined as any new illness or change in an existing illness, regardless of whether or not it was thought to be related to treatment. The numbers of medical events occurring before and after the Ventolin Evohaler® was used were compared.

All clinical information received from GPs is anonymised and treated in strict confidence by the DSRU, which is allowed under the Data Protection Act of 1998 to hold such information for research purposes.

Results

Information on 10,472 patients treated with Ventolin®, 13% of whom were children, was provided by 1,365 GPs. The patient's asthma was described as "mild" in 47%, "moderate" in 44% and "severe" in 9%. By October 1999, information was available for 4,725 patients who had been transferred to the Ventolin Evohaler®. No increases in the rates of serious or minor events were seen after transfer to the Ventolin Evohaler®. No serious events, birth abnormalities or deaths were considered to be related to either form of Ventolin® treatment.

Conclusion

There were no concerns identified about the safety of Ventolin Evohaler® when used in the treatment of asthma.