A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence

A 24-week Randomized, Controlled, Multicenter, Open-label Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence of COPD Subjects Receiving Ultibro® Breezhaler® Treatment Using the Concept2 Inhaler for Dose Administration and Tracking

This study was evaluating the effect of reminder notifications and motivational/adaptive messages on treatment adherence behavior in subjects with COPD. The effect will be measured over 24 weeks on the subject's on time treatment adherence and total treatment adherence. The delivery of the medication and tracking of inhaler use is done by the Concept2 inhaler. The reminder notification, feedback on inhaler use and motivational messages are provided by the patient application, who is receiving the inhaler use information from the Concept2 inhaler.

This study was evaluating whether subjects with COPD on Ultibro® Breezhaler® clinical trial formulation once daily dosing regimen using the Concept2 inhaler in conjunction with a patient application collecting data and sending reminder notifications and motivational/adaptive messages aimed at encouraging treatment adherence, have improved treatment adherence compared to subjects using the Concept2 inhaler alone (usual care). The delivery of the medication and tracking of inhaler use is done by the Concept2 inhaler. The reminder notifications, feedback on inhaler use and motivational messages for the subject are sent by the patient application based on the received subjects inhaler use information from the Concept2 inhaler.

The effect will be measured over 24 weeks on the subject's on time treatment adherence (days when the subjects inhaled within +/- 2 hours of the subjects preferred inhalation time) and total treatment adherence (days when patient inhaled at least one dose).

The study population consisted male and female adult patients, 18 years or older with a clinical diagnosis of COPD, a smoking history of 10 pack years, receiving Ultibro Breezhaler treatment for at least 3 months prior to screening and documented poor treatment adherence.

After 6 weeks of screening patients will be randomized to either the Usual Care group in which they will continue to receive Ultibro Breezhaler treatment via the Concept2, or the Telehealth group in which they will additionally receive a tablet device pre-installed with a patient app.

In addition to on time treatment adherence and total treatment adherence, illness and treatment beliefs will be collected via a questionnaire and patient's health status from the EQ5D-5L and SGRQ-C Questionnaire. Key safety assessments are COPD exacerbation and AE/SAE, device deficiencies and device events, drug administration errors, physical exam, vital signs and urine or serum pregnancy test.

Inclusion Criteria:

• Signed informed consent
• Have a total adherence of more than 10% but less than or equal to 70% during Screening period
• Current or ex-smokers who have a smoking history of at least 10 pack years.
• A diagnosed COPD
• Taking Ultibro® Breezhaler® for at least 3 month prior to Visit 1
• Have been in the Screening period ≥ 35 days.

Exclusion Criteria:

• Pregnant or lactating women
• Women of child-bearing potential
• Subjects having a history of reactions/hypersensitivity to inhaled drugs or drugs of a similar class
• Subjects having a history of reactions/hypersensitivity to lactose or any of the other ingredients of trial medication.
• Subjects with relevant concomitant diseases
• Subjects who have had a COPD exacerbation 6 weeks prior to Visit 1 or between V1 and randomization
• Subjects who have had a respiratory tract infection within 3 weeks prior to Visit 1 or between V1 and randomization
• Use of investigational drugs or other investigational devices at the time of enrollment
• Subjects with a preferred inhalation time between 10.00 pm and 2.00 am.
• Subjects taken off Ultibro® Breezhaler® treatment/inhaler use by the investigator during the Screening period for more than 7 days.
• Subjects not returning all Concept2 inhalers received during the Screening period
• Subjects who have demonstrated inability or unwillingness to use the digital system or to fill in questionnaires.

Other protocol-defined inclusion/exclusion criteria may apply