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INCA SUn: A prospective randomised multicentre study to optimise the management of Symptomatically Uncontrolled asthma.

Despite extensive treatment about 10% of asthma patients continue to have uncontrolled symptoms, such patients are classed as having severe asthma. Patients with severe asthma are the drivers of the bulk of asthma costs with greater health care utilization and time lost from work. It is widely recognised that poor adherence to therapy is at least part of the reason why patients fail to control their symptoms.
The applicants have developed a technology to objectively and longitudinally assess adherence to inhalers. Based on audio analysis, this technology identifies when an inhaler has been used, if there has been an error in its use and if the individual has inhaled with an adequate inspiratory flow. The applicants have also developed a treatment intervention program during which this information is collected and related to the patient’s concurrent symptoms, reliever inhaler use and PEFR. Displaying this longitudinally collected information on treatment and clinical progress allows the patient and clinician to jointly optimise asthma control and identify asthma risks.
Pilot studies have shown that when the information on adherence, symptoms and lung function are used as a patient centered education tool this leads to better asthma control, compared to standard approaches. The proposed study will compare this approach to standard management of these patients. This will be a prospective randomised, multicentre study of patients with severe asthma comparing two different interventions. One arm will use the information from the device in a patient centred teaching intervention. In the other comparator, current best practice will be performed. The primary endpoint will be a comparison of asthma control between the two approaches at the end of the intervention. Secondary endpoints will include assessments of quality of life, exacerbation rates, healthcare costs and cost effectiveness of the two approaches at the end of one year.