A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients

Alison Moore, Andrew Preece, Raj Sharma, Liam G. Heaney, Richard W. Costello, Robert A. Wise, Andrea Ludwig-Sengpiel, Giselle Mosnaim, Jamie Rees, Ryan Tomlinson, Ruth Tal-Singer, David A. Stempel, Neil Barnes

Research output: Contribution to journalArticlepeer-review


Suboptimal adherence to maintenance therapy contributes to poor asthma control and exacerbations. This study evaluated the effect of different elements of a connected inhaler system (CIS), comprising clip-on inhaler sensors, a patient-facing app and a healthcare professional (HCP) dashboard, on adherence to asthma maintenance therapy. This was an open-label, parallel-group, 6-month, randomised controlled trial in adults with uncontrolled asthma (asthma control test (ACT) score less than 20) on fixed-dose inhaled corticosteroids/ long-acting β-agonist maintenance therapy (n=437). All subjects received fluticasone furoate/vilanterol ELLIPTA dry-powder inhalers for maintenance and salbutamol/albuterol metered-dose inhalers for rescue, with a sensor attached to each inhaler. Participants were randomised to one of five CIS study arms (allocation ratio 1:1:1:1:1) reflecting the recipient of the data feedback from the sensors, as follows: 1) maintenance use to participants and HCPs (n=87); 2) maintenance use to participants (n=88); 3) maintenance and rescue use to participants and HCPs (n=88); 4) maintenance and rescue use to participants (n=88); and 5) no feedback (control) (n=86). For the primary endpoint, observed mean±SD adherence to maintenance therapy over months 4-6 was 82.2±16.58% (n=83) in the “maintenance to participants and HCPs” arm and 70.8±27.30% (n=85) in the control arm. The adjusted least squares mean±SE was 80.9±3.19% and 69.0±3.19%, respectively (study arm difference: 12.0%, 95% CI 5.2-18.8%; p<0.001). Adherence was also significantly greater in the other CIS arms versus the control arm. The mean percentage of rescue medication free days (months 4-6) was significantly greater in participants receiving data on their rescue use compared with controls. ACT scores improved in all study arms with no significant differences between groups. A CIS can improve adherence to maintenance medication and reduce rescue medication use in patients with uncontrolled asthma.

Original languageEnglish (US)
Article number2003103
JournalEuropean Respiratory Journal
Issue number6
StatePublished - Jun 1 2021

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine


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