A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Concept2 inhaler; Concept2 inhaler with patient application
Intervention description: Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler; Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler with application used for monitoring
Phase: Phase 3
Study type: Interventional
Primary purpose: Device Feasibility
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; Adherence; Dose Tracking; Concept2; Digital Adherence System; Ultibro Breezhaler

Summary:

      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.
    

Eligibility criteria:

        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