A Study Comparing SoC vs the BF Digihaler DS in Adults with Asthma

• Research type

  Research Study

• Full title

  CONNected Electronic Inhalers Asthma Control Trial 3 (“CONNECT 3”), a 24-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison Study of Standard of Care Treatment Versus the Budesonide/Formoterol Digihaler Digital System, to Optimize Outcomes in Adult Patients with Asthma

• IRAS ID

  1004894

• Contact name

  Guilherme Safioti

• Contact email

  praregulatoryaffairs@prahs.com

• Sponsor organisation

  Teva Branded Pharmaceutical Products R&D, Inc.

• Eudract number

  2021-003951-41

• Research summary

  This research study is to see if the Budesonide/Formoterol (BF) Digihaler Digital System (DS) is effective in getting better control of asthma compared to usual treatment for participants at least 18 years of age with asthma. The BF Digihaler DS is an asthma treatment that includes an inhaler with a digital data tracker and Bluetooth capability built in, for storing and transmitting time-stamped inhalation information to the smartphone.
  The BF Digihaler DS is not currently marketed in any country. However Teva’s medicinal product budesonide/formoterol fumarate dihydrate is approved and commercially available in the market (trade name DUORESP SPIROMAX) for the maintenance and rescue treatment of asthma in the following countries: European Union, Iceland, Liechtenstein, Norway, United Kingdom, Argentina, Australia, Bosnia and Herzegovina, Chile, Israel, Kazakhstan, Macedonia, Montenegro, New Zealand, Peru, Russia, Serbia, Singapore, South Korea and Thailand. The BF Digihaler DS, delivers a dose of BF equivalent to Duoresp Spiromax and adds electronic capabilities intended to provide patients with reminders, usage reports and feedback. Approximately 500 people will participate, who have asthma treated with inhaled medications that contain corticosteroid and long acting bronchodilator. Participants will be enrolled in two groups, to be placed on either the BF Digihaler DS (DS group) or to remain on their own physician prescribed medication (standard of care – SoC- group). Participant groups will be determined at random. They will have a [1:1] chance of being placed on the DS group or on SoC group. Participants enrolled in the DS group will be asked to discontinue current treatment and use BF Digihaler as asthma maintenance and reliever therapy. All other asthma maintenance medications may be continued. Participation in the study will last 24 weeks. This will involve 3 visits to the study doctor and a follow-up call two weeks after treatment completion.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  22/YH/0110

• Date of REC Opinion

  4 Jul 2022

• REC opinion

  Further Information Favourable Opinion