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A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects

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ClinicalTrials.gov Identifier: NCT03380429
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: RELVAR/BREO Drug: Salbutamol Device: Smart phone app Device: HCP Dashboard Device: Sensors Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
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)
Primary Purpose: Treatment
Official Title: An Open Label, Randomised, Parallel Group Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Relvar/Breo ELLIPTA Therapy, in Asthmatic Subjects With Poor Control
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : January 25, 2019
Estimated Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Data on Maintenance use supplied to Subject and HCP
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensor attached to RELVAR/BREO ELLIPTA will be fed back to the subject via an app on smart phone and to the subject's HCP via an online dashboard.
Drug: RELVAR/BREO
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Smart phone app
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 data from sensors attached to ELLIPTA DPI and MDI will be fed back to subjects via the app on their smartphone.

Device: HCP Dashboard
The information from sensors attached to ELLIPTA DPI and MDI will be reviewed by the subjects HCP via an online dashboard.

Device: Sensors
Clip on sensors will be fitted on to RELVAR/BREO ELLIPTA DPI and salbutamol MDI to electronically record the actuation data.

Experimental: Data on Maintenance use supplied to Subject
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensor attached to RELVAR/BREO ELLIPTA will be fed back to the subject via an app on smart phone.
Drug: RELVAR/BREO
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Smart phone app
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 data from sensors attached to ELLIPTA DPI and MDI will be fed back to subjects via the app on their smartphone.

Device: Sensors
Clip on sensors will be fitted on to RELVAR/BREO ELLIPTA DPI and salbutamol MDI to electronically record the actuation data.

Experimental: Data on Maintenance and Rescue use supplied to Subject and HCP
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensors attached to RELVAR/BREO ELLIPTA and salbutamol MDI will be fed back to both subject and HCP. The data will be fed back to the subject through an app and to HCP through an online dashboard.
Drug: RELVAR/BREO
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Smart phone app
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 data from sensors attached to ELLIPTA DPI and MDI will be fed back to subjects via the app on their smartphone.

Device: HCP Dashboard
The information from sensors attached to ELLIPTA DPI and MDI will be reviewed by the subjects HCP via an online dashboard.

Device: Sensors
Clip on sensors will be fitted on to RELVAR/BREO ELLIPTA DPI and salbutamol MDI to electronically record the actuation data.

Experimental: Data on Maintenance and Rescue use supplied to Subject
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensors attached to RELVAR/BREO ELLIPTA and salbutamol MDI will be fed back to subject through an app.
Drug: RELVAR/BREO
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Smart phone app
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 data from sensors attached to ELLIPTA DPI and MDI will be fed back to subjects via the app on their smartphone.

Device: Sensors
Clip on sensors will be fitted on to RELVAR/BREO ELLIPTA DPI and salbutamol MDI to electronically record the actuation data.

Active Comparator: No data supplied to Subject or HCP
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Subjects will be provided with a home hub through which their data will be uploaded during the study but the subjects and their HCP will not be able to view the data.
Drug: RELVAR/BREO
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.

Drug: Salbutamol
Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.

Device: Sensors
Clip on sensors will be fitted on to RELVAR/BREO ELLIPTA DPI and salbutamol MDI to electronically record the actuation data.




Primary Outcome Measures :
  1. Percentage of ELLIPTA doses taken between months 4 and 6 [ Time Frame: Month 4 and up to Month 6 ]
    The percentage of ELLIPTA doses taken, that is, daily adherence to maintenance medication will be determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover is opened and closed. Daily adherence is defined as the subject taking one dose of RELVAR/BREO ELLIPTA, within a 24-hour period, starting at 12.00 anti meridiem (am) each day. The adherence to ELLIPTA maintenance therapy when both the subject and the HCP are supplied with data from the maintenance sensor versus no data supplied to the subject and HCP will be summarized.


Secondary Outcome Measures :
  1. Percentage of ELLIPTA doses taken between months 4 and 6 [ Time Frame: Month 4 and up to Month 6 ]
    The percentage of ELLIPTA doses taken, that is, daily adherence to maintenance medication will be determined by the clip-on sensor attached to ELLIPTA which records the time and date when the ELLIPTA cover is opened and closed. Daily adherence is defined as the subject taking one dose of RELVAR/BREO ELLIPTA, within a 24-hour period, starting at 12.00 am each day. The effect on adherence to maintenance therapy when maintenance data is only supplied to subjects versus no data supplied to the subject; rescue and maintenance data are supplied to subject and HCP versus no data supplied to the subject and HCP; rescue and maintenance data only supplied to subject versus no data supplied to the subject will be assessed.

  2. Percentage of ELLIPTA doses taken between months 1 and 3 [ Time Frame: Month 1 and up to Month 3 ]
    The percentage of ELLIPTA doses taken, that is, daily adherence to maintenance medication will be determined by the clip-on sensor attached to ELLIPTA which records the time and date when the ELLIPTA cover is opened and closed. Daily adherence is defined as the subject taking one dose of RELVAR/BREO ELLIPTA, within a 24-hour period, starting at 12.00 am each day.

  3. Percentage of ELLIPTA doses taken between months 1 and 6 [ Time Frame: Month 1 and up to Month 6 ]
    The daily adherence to maintenance medication will be determined by the clip-on sensor attached to ELLIPTA which records the time and date when the ELLIPTA cover is opened and closed. Daily adherence is defined as the subject taking one dose of RELVAR/BREO ELLIPTA, within a 24-hour period, starting at 12.00 am each day.

  4. Percentage of rescue free days [ Time Frame: Month 4 and up to Month 6 ]
    Data for rescue medication use will be collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI is actuated. Percentage of rescue free days will be determined by the rescue sensor records of date, time and number of inhaler actuations.

  5. Total rescue medication use [ Time Frame: Month 4 and up to Month 6 ]
    Data for rescue medication use will be collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI is actuated. Total rescue use will be determined by the rescue sensor records of date, time and number of inhaler actuations.

  6. Change from Baseline in Asthma Control Test (ACT) total score [ Time Frame: Baseline and Month 6 ]
    The ACT is a validated questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale ranging from 1 to 5. The subjects will be required to complete the questions to obtain a score that may range between 5 and 25, with higher scores indicating better control. An ACT score of 5 to 19 suggests that the subject's asthma is unlikely to be well controlled. A score of 20 to 25 suggests that the subject's asthma is likely to be well controlled. The total score is calculated as the sum of the scores from all 5 questions. Subjects will complete the ACT using the electronic version of the electronic patient reported outcome (ePRO) device at the clinical site.

  7. Percentage of subjects attaining asthma control [ Time Frame: Month 6 ]
    Percentage of subjects attaining asthma control is defined as subjects with an ACT score >=20. The ACT is a validated questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale ranging from 1 to 5. The subjects will be required to complete the questions to obtain a score that may range between 5 and 25, with higher scores indicating better control. The total score is calculated as the sum of the scores from all 5 questions. Subjects will complete the ACT using the electronic version of ePRO device at the clinical site.

  8. Percentage of subjects with an increase from Baseline >=3 in ACT total score [ Time Frame: Baseline and Month 6 ]
    The ACT is a validated questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale ranging from 1 to 5. The subjects will be required to complete the questions to obtain a score that may range between 5 and 25, with higher scores indicating better control. An ACT score of 5 to 19 suggests that the subject's asthma is unlikely to be well controlled. A score of 20 to 25 suggests that the subject's asthma is likely to be well controlled. The total score is calculated as the sum of the scores from all 5 questions. Subjects will complete the ACT using the electronic version on the ePRO device at the clinical site.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380429


Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03380429     History of Changes
Other Study ID Numbers: 207040
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by GlaxoSmithKline:
Connected Inhaler System
Metered Dose Inhaler
ELLIPTA
RELVAR/BREO
Dry Powder Inhaler
Salbutamol
Asthma

Additional relevant MeSH terms:
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action