A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
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
2 other identifiers
interventional
437
7 countries
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Jan 2018
Shorter than P25 for phase_4 asthma
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedStudy Start
First participant enrolled
January 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2019
CompletedResults Posted
Study results publicly available
February 5, 2020
CompletedApril 12, 2021
March 1, 2021
12 months
December 15, 2017
January 23, 2020
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; ("Cohort 1: Data on Maintenance Use Supplied to Participant and HCP" and"Cohort 5: no Data Supplied to Participant or HCP")
Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 anti-meridiem (a.m.) each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Analysis was carried out by Analysis of Covariance (ANCOVA) model. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The daily adherence to ELLIPTA maintenance therapy when both the participant and the HCP were supplied with data from the maintenance sensor (Cohort 1) versus no data supplied to the participant or HCP (Cohort 5) is summarized.
Month 4 to Month 6
Secondary Outcomes (9)
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor
Month 4 to Month 6
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor
Month 1 to Month 3
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor
Month 1 to Month 6
Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor
Month 4 to Month 6
Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor
Month 4 to Month 6
- +4 more secondary outcomes
Study Arms (5)
Data on Maintenance use supplied to Subject and HCP
EXPERIMENTALEligible 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.
Data on Maintenance use supplied to Subject
EXPERIMENTALEligible 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.
Data on Maintenance and Rescue use supplied to Subject and HCP
EXPERIMENTALEligible 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.
Data on Maintenance and Rescue use supplied to Subject
EXPERIMENTALEligible 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.
No data supplied to Subject or HCP
ACTIVE COMPARATOREligible 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- ACT score \<20 at randomization visit (visit 2).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (66)
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Flossmoor, Illinois, 60422, United States
GSK Investigational Site
Glenview, Illinois, 60026, United States
GSK Investigational Site
Hazelwood, Missouri, 63042, United States
GSK Investigational Site
Charlotte, North Carolina, 28277, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Richmond, Virginia, 23230, United States
GSK Investigational Site
Greenfield, Wisconsin, 53228, United States
GSK Investigational Site
Kelowna, British Columbia, V1W 1V3, Canada
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
GSK Investigational Site
Ajax, Ontario, L1S 2J5, Canada
GSK Investigational Site
Burlington, Ontario, L7N 3V2, Canada
GSK Investigational Site
London, Ontario, N5W 6A2, Canada
GSK Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
GSK Investigational Site
Toronto, Ontario, M5T 3A9, Canada
GSK Investigational Site
Toronto, Ontario, M9V 4B4, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Windsor, Ontario, N8X2G1, Canada
GSK Investigational Site
Montreal, Quebec, H4J 1C5, Canada
GSK Investigational Site
Québec, Quebec, G1N 4V3, Canada
GSK Investigational Site
Québec, Quebec, G1W 4R4, Canada
GSK Investigational Site
Québec, Quebec, G3K 2P8, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1L 0H8, Canada
GSK Investigational Site
Victoriaville, Quebec, G6P 6P6, Canada
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562, Germany
GSK Investigational Site
Darmstadt, Hesse, 64283, Germany
GSK Investigational Site
Warendorf, North Rhine-Westphalia, 48231, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Leipzig, Saxony, 04357, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552, Germany
GSK Investigational Site
Berlin, 10119, Germany
GSK Investigational Site
Berlin, 12203, Germany
GSK Investigational Site
Berlin, 13156, Germany
GSK Investigational Site
Berlin, 14059, Germany
GSK Investigational Site
Napoli, Campania, 80131, Italy
GSK Investigational Site
Salerno, Campania, 84131, Italy
GSK Investigational Site
Pordenone, Friuli Venezia Giulia, 33170, Italy
GSK Investigational Site
Palermo, Sicily, 90146, Italy
GSK Investigational Site
Pisa, Tuscany, 56124, Italy
GSK Investigational Site
Breda, 4818 CK, Netherlands
GSK Investigational Site
Groningen, 9728 NT, Netherlands
GSK Investigational Site
Hengelo, 7555 DL, Netherlands
GSK Investigational Site
Hoorn, 1624 NP, Netherlands
GSK Investigational Site
The Hague, 2526 HW, Netherlands
GSK Investigational Site
Zutphen, 7207 AE, Netherlands
GSK Investigational Site
A Coruña, 15011, Spain
GSK Investigational Site
Balenyà (Barcelona), 08550, Spain
GSK Investigational Site
Barcelona, 08028, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
La Roca Del Valles (Barcelona), 08430, Spain
GSK Investigational Site
Loja/ Granada, 18300, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Madrid, 28044, Spain
GSK Investigational Site
Peralada( Girona), 17491, Spain
GSK Investigational Site
Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom
GSK Investigational Site
Wigan, Lancashire, WN1 2NN, United Kingdom
GSK Investigational Site
Wellingborough, Northamptonshire, NN8 4RW, United Kingdom
GSK Investigational Site
Addlestone, Surrey, KT15 2BH, United Kingdom
GSK Investigational Site
Rotherham, Yorkshire, S65 1DA, United Kingdom
GSK Investigational Site
Bristol, BS37 4AX, United Kingdom
GSK Investigational Site
Chelmsford, CM1 7ET, United Kingdom
GSK Investigational Site
Chertsey, Surrey, KT16 0PZ, United Kingdom
GSK Investigational Site
Harrogate, HG2 7SX, United Kingdom
Related Publications (1)
Moore A, Preece A, Sharma R, Heaney LG, Costello RW, Wise RA, Ludwig-Sengpiel A, Mosnaim G, Rees J, Tomlinson R, Tal-Singer R, Stempel DA, Barnes N. A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients. Eur Respir J. 2021 Jun 4;57(6):2003103. doi: 10.1183/13993003.03103-2020. Print 2021 Jun.
PMID: 33334936DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2017
First Posted
December 21, 2017
Study Start
January 31, 2018
Primary Completion
January 24, 2019
Study Completion
January 24, 2019
Last Updated
April 12, 2021
Results First Posted
February 5, 2020
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study is available via the Clinical Study Data Request site.