Clinical Data Hub
The evidence behind the Digihaler system
CONNECT1: The first study evaluating the Digihaler system vs SoC9
Assessing the impact of the Digihaler system on asthma management and level of asthma control9
As stated in the FDA-approved
Prescribing Information, there is no
evidence the use of the
leads to improved clinical outcomes,
including safety and effectiveness.1
CONNECT1 was a 12-week, open-label,
multicenter, parallel group study
consisting of 333 patients 13 years of
and older with asthma, with an ACT of
<19, who were receiving ICS and LABA,
using inhaled albuterol, and
to replace all other reliever medications
with ProAir® Digihaler® (albuterol sulfate).9
- Improvement in asthma control defined as achievement of well-controlled asthma
(ACT ≥20) and/or gaining a clinically meaningful improvement in ACT score of at least 3 units from baseline to Week 129
- Differences in asthma management actions (interactions and interventions)9
- Change in weekly average SABA use and weekly number of SABA-free days from baseline in the ProAir Digihaler system group9
- Acceptability and usability of the ProAir
Digihaler system utilizing the 10-question
System Usability Scale9
- Adverse events9
- *Inhaler use is recorded as an event when the cap is opened or a patient inhales.
Abbreviation: SoC=standard of care
Objective data from the Digihaler system: Results of the secondary endpoints
The CONNECT1 study assessed the impact of the Digihaler system on SABA use, HCP-Patient
interactions, and the acceptability and usability of the Digihaler system
Reduction in mean weekly SABA use and increase in weekly number of
SABA-free days from baseline in the Digihaler system group at 12 weeks
Change in SABA use recorded over time by the Digihaler system9
Weekly Average SABA Use (n=135)
Weekly Number of SABA-Free Days (n=135)
Higher number of HCP-Patient interactions with the Digihaler system versus Standard of Care
HCP-Patient interactions with the Digihaler system vs Standard of Care1,9
More HCP-reported interactions* due to poor inhaler technique in the Digihaler system group
More discussions* about inhaler technique and/or using† the inhaler as prescribed in the Digihaler system group
Fewer interactions* took place solely due to routine scheduling
*Interactions were defined as office visits or telephone calls. Interventions were defined as the content of discussions.
†Inhaler use is recorded as an event when the cap is opened or a patient inhales.
Assessment of the Digihaler system using the System Usability Scale14,15
The System Usability Scale consists of a 10-item questionnaire* and is a reliable tool for measuring usability.
Participants rated the app, and investigational sites rated the dashboard, as "Good" in terms of acceptability
*SUS consists of questions with 5 response options for respondents, from “strongly agree” to “strongly disagree.”
†The higher the number, the more favorable the usability.
‡Participants n=140, Sites n=27.
The number of participants who had adverse events was similar across the 2 groups (28 in the ProAir Digihaler system group and 26 in the SoC group). No adverse events led to discontinuation or were considered device-related.9