Digital Inhalers May Improve Uncontrolled Asthma Management

Allergies & Asthma

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Use of digital measurement tools to track individual adherence to treatment helped avoid raising doses or adding medications and improved adherence in patients with uncontrolled asthma, the INCA Sun trial found.

After 32 weeks, 14% of patients in the treatment group and 32% of the control group saw an increase in their asthma medication burden (OR 0.31, 95% CI 0.15-0.64, P=0.0015), reported Richard Costello, MD, of RCSI University of Medicine and Health Science in Dublin, Ireland, and co-authors.

The coprimary endpoint of average adherence to medication at 20 to 32 weeks was 64.9% with the intervention and 55.5% in the control group (P=0.0012), according to the single-blind randomized trial published in The Lancet Respiratory Medicine.

“Identifying patients with difficult-to-control asthma is one of the biggest clinical challenges respiratory physicians in practice have to attend to,” they noted, as it can be difficult to sort out modifiable factors like poor inhaler technique from severe asthma that requires escalation of therapy.

“The results show that patients who have their asthma digitally managed had considerably lower treatment and economic burden and better adherence compared with patients in the control group, and there was no difference between groups in terms of asthma control,” the group wrote.

The trial included 213 adults with uncontrolled asthma seen at 10 severe asthma clinics across Ireland, Northern Ireland, and England who had an asthma control test score of 19 or less and at least one severe exacerbation in the prior year despite high-dose inhaled corticosteroid use. All patients were provided with inhalers with a digital Inhaler Compliance Assessment (INCA) and met with nurses for educational visits at weeks eight, 20, and 32. A decision support tool suggested therapy changes, which could be overruled by the clinician.

The intervention group received medication adjustments by their physician based on data received from the inhalers about twice-daily digital peak expiratory flow (ePEF), adherence to inhaler use, patient asthma history, as well as the patient’s own observations of their asthma management.

In the control group, patients were not made aware of their own adherence to asthma use or issues observed in their inhaler technique. Pharmacy refill rates were the data physicians had available on adherence to assess if adjustment to treatment was needed.

The first primary endpoint was the proportion of patients recommended to have a net increase in treatment, encompassing escalation of inhaled corticosteroid medication at weeks 8, escalation or reduction at weeks 20 and 32 medication as adjusted by the physician, and add-on biological treatment.

Among the components of that endpoint at 32 weeks, only 16% of treatment participants increased their fluticasone propionate dose from 500 to 1,000 μg daily, while 44% of the control participants required the same (adjusted OR 2.43, 95% CI 1.13-5.20, P=0.022).

The importance of distinguishing difficult-to-control asthma from severe asthma is shown by finding that “despite all patients meeting the criteria for an add-on biological agent at the start of the study, at the end of the study 10% of the patients in the digitally informed group and 20% in the control group met the criteria for an add-on biological agent,” the researchers pointed out (OR 0.42, 95% CI 0.19-0.95, P=0.038).

Adverse events occurred among 55% of the intervention group patients and 45% of the control group patients, though none of these events were deemed treatment related.

This study did have several limitations, including lack of biomarker and spirometry data during a portion of the trial due to COVID-19 restrictions. In addition, both digital and traditional methods were used to record data, which may have affected results.

The authors stressed the practical meaning of their findings, with “cost implications for patients with a reduction in high-dose inhaled corticosteroid treatment, which also leads to a reduction in the risk of side-effects.”

“Clinicians can also use this digital approach to distinguish between severe and difficult-to-manage asthma which might require add-on biological therapy,” they wrote.

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    Elizabeth Short is a staff writer for MedPage Today. She often covers pulmonology and allergy & immunology. Follow


This study was supported by the Health Research Board of Ireland, Medical Research Council, INTERREG Europe, and an investigator-initiated project grant from GSK.

Costello reported relationships with GSK, Aerogen, Enterprise Ireland, AstraZeneca, Teva, PMD solutions, and Novartis. Costello also reported a patent for the use of acoustics to assess inhaler adherence, quantify adherence, and predict exacerbations. Co-authors reported various relationships with industry and government.

Primary Source

The Lancet Respiratory Medicine

Source Reference: Costello RW, et al “Use of digital measurement of medication adherence and lung function to guide the management of uncontrolled asthma (INCA Sun): a multicentre, single-blinded, randomised clinical trial” Lancet Respir Med 2023; DOI: 10.1016/S2213-2600(22)00534-3.

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