A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Intervention: RELVAR/BREO; Salbutamol; Smart phone app; HCP Dashboard; Sensors
Intervention description: RELVAR/BREO will be available at doses of 100/25 micrograms (µg) and 200/25 µg to be administered via ELLIPTA DPI. Subjects will be administered one inhalation of RELVAR/BREO once daily.; Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.; Subjects will be required to download an app associated with sensor on their smartphone. The sensors attached to the inhalers will be connected to the smartphone via Bluetooth.; The information from sensors will be reviewed by the HCP via an online dashboard.; Clip-on sensors will be fitted to electronically record the actuation data.
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI. Clip-on sensors will be attached to both inhalers which will provide data on maintenance therapy and rescue medication use to the subjects and their HCP. Subjects will be randomized into five treatment arms in a ratio of 1:1:1:1:1 depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol MDI, is fed back to the subject or subject and HCP, or not at all.
Masking: None (Open Label)
Enrollment: 437.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Connected Inhaler System; Metered Dose Inhaler; ELLIPTA; RELVAR/BREO; Dry Powder Inhaler; Salbutamol; Asthma

Summary:

      GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which
      can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the
      ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the
      rescue medication metered dose inhaler (MDI). The data from both sensors will be fed back to
      the subject via an application (app) on smart phone and will be reviewed by the subject's
      health care professional (HCP) via an online dashboard. The sensors, app, dashboard and
      systems to provide data comprise the CIS. This study will be the first to evaluate the effect
      of CIS on adherence to maintenance therapy in subjects with uncontrolled asthma. This is an
      open-label, randomized, parallel group study in asthmatic subjects currently on a fixed dose
      inhaled corticosteroid (ICS)/long-acting beta 2 agonist (LABA) maintenance therapy. Eligible
      subjects will receive RELVAR®/BREO® maintenance therapy via ELLIPTA DPI and salbutamol rescue
      medication via MDI with sensors attached to both inhalers during the run-in period, which may
      last for up to 3 months. Eligible subjects will then be randomized into five treatment arms
      depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol
      MDI, is fed back to the subject or subject and HCP, or not at all. The treatment period for
      the study is approximately 6 months and there will be a follow-up period one week post last
      visit. The total duration of a subject in the study will be approximately 9 months. RELVAR,
      BREO and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18 years or older, at the time of signing the informed consent.

          -  Subjects with documented physician diagnosis of asthma as their primary respiratory
             disease.

          -  ACT score <20 at screening visit.

          -  Non-smokers (never smoked or not smoking for >6 months with <10 pack years history
             (Pack years = [cigarettes per day smoked/20] multiplied by number of years smoked).

          -  Male or female subjects will be included. A female subject is eligible to participate
             if she is not pregnant, not breastfeeding, and at least one of the following
             conditions applies: (i) Not a woman of childbearing potential (WOCBP). (ii) A WOCBP
             who agrees to follow the contraceptive guidance during the treatment period and for at
             least 5 days] after the last dose of study treatment.

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the consent form and protocol.

          -  Subject understands and is willing, able, and likely to comply with study procedures
             and restrictions.

          -  Subject must be able to read in a language supported by the smart phone app in their
             region.

          -  Subject must have been on maintenance therapy (Fixed dose combination ICS/LABA) for 3
             months, cannot have changed dose in the month prior to screening and be able to change
             to an equivalent dose of RELVAR/BREO for the duration of the study. Other background
             asthma medication such as anti-leukotrienes and oral corticosteroids are permitted
             provided the dose has been stable for 1 month prior to screening.

          -  Subject must be able to change to Salbutamol/Albuterol MDI rescue for the duration of
             the study and judged capable of withholding albuterol/salbutamol for at least 6 hours
             prior to study visits.

          -  Subject must have their own Android or iPhone operating system (IOS) smart phone and a
             data package suitable for the installation and running of the app and sending and
             receiving data. Data used by the CIS is approximately 1 megabyte (MB) per month as a
             maximum; this is less data than a 1 minute video streamed from YouTube (2MB).

          -  Subjects must be willing and able to download the app on their personal smart phone
             and keep it turned on for the duration of the study. This will also require Bluetooth
             to be turned on for duration of the study. Subjects will also have to turn on mobile
             data for the app for the duration of study; unless travelling and when extra data
             roaming costs could be incurred.

        Inclusion criteria for randomization:

          -  ACT score <20 at randomization visit (visit 2).

        Exclusion Criteria:

          -  Subjects with a known or suspected alcohol or drug abuse which in the opinion of the
             investigator could interfere with the subject's proper completion of the protocol
             requirement.

          -  History of life threatening asthma: Defined as an asthma episode that required
             intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic
             seizures within the last 6 months.

          -  A lower respiratory tract infection within 7 days of the screening visit.

          -  Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other
             respiratory disorders including active tuberculosis, lung cancer, bronchiectasis,
             sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or
             other active pulmonary diseases.

          -  History of hypersensitivity/intolerance to any components of the study inhalers
             (example, lactose, magnesium stearate). In addition, subjects with a history of severe
             milk protein allergy that, in the opinion of the study physician, contraindicates
             participation will also be excluded.

          -  Historical or current evidence of clinically significant or rapidly progressing or
             unstable cardiovascular, neurological, cardiovascular, neurological, renal, hepatic,
             immunological, endocrine (including uncontrolled diabetes or thyroid disease) or
             hematological abnormalities that are uncontrolled. Significant is defined as any
             disease that, in the opinion of the investigator, would put the safety of the subject
             at risk through participation, or which would affect the analysis if the
             disease/condition exacerbated during the study.

          -  Subjects who have ever received treatment with biological based therapy example,
             omalizumab, mepolizumab, for asthma.

          -  Subjects who have received an investigational drug and/or medical device within 30
             days of entry into this study (Screening), or within five drug half-lives of the
             investigational drug, whichever is longer.

          -  A subject will not be eligible for this study if he/she is an immediate family member
             of the participating investigator, sub-investigator, study coordinator, employee of
             the participating investigator, or any family member of a Propeller Health employee.