A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
NCT ID: NCT03380429
Last Updated: 2021-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
437 participants
INTERVENTIONAL
2018-01-31
2019-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
HCP Dashboard
The information from sensors will be reviewed by the HCP via an online dashboard.
Sensors
Clip-on sensors will be fitted to electronically record the actuation data.
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.
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.
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.
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.
Sensors
Clip-on sensors will be fitted to electronically record the actuation data.
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.
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.
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.
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.
HCP Dashboard
The information from sensors will be reviewed by the HCP via an online dashboard.
Sensors
Clip-on sensors will be fitted to electronically record the actuation data.
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.
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.
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.
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.
Sensors
Clip-on sensors will be fitted to electronically record the actuation data.
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.
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.
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.
Sensors
Clip-on sensors will be fitted to electronically record the actuation data.
Interventions
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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.
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.
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.
HCP Dashboard
The information from sensors will be reviewed by the HCP via an online dashboard.
Sensors
Clip-on sensors will be fitted to electronically record the actuation data.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Aventura, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Flossmoor, Illinois, United States
GSK Investigational Site
Glenview, Illinois, United States
GSK Investigational Site
Hazelwood, Missouri, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Medford, Oregon, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Greenfield, Wisconsin, United States
GSK Investigational Site
Kelowna, British Columbia, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Ajax, Ontario, Canada
GSK Investigational Site
Burlington, Ontario, Canada
GSK Investigational Site
London, Ontario, Canada
GSK Investigational Site
Sarnia, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Windsor, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
GSK Investigational Site
Victoriaville, Quebec, Canada
GSK Investigational Site
Rüdersdorf, Brandenburg, Germany
GSK Investigational Site
Darmstadt, Hesse, Germany
GSK Investigational Site
Warendorf, North Rhine-Westphalia, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Napoli, Campania, Italy
GSK Investigational Site
Salerno, Campania, Italy
GSK Investigational Site
Pordenone, Friuli Venezia Giulia, Italy
GSK Investigational Site
Palermo, Sicily, Italy
GSK Investigational Site
Pisa, Tuscany, Italy
GSK Investigational Site
Breda, , Netherlands
GSK Investigational Site
Groningen, , Netherlands
GSK Investigational Site
Hengelo, , Netherlands
GSK Investigational Site
Hoorn, , Netherlands
GSK Investigational Site
The Hague, , Netherlands
GSK Investigational Site
Zutphen, , Netherlands
GSK Investigational Site
A Coruña, , Spain
GSK Investigational Site
Balenyà (Barcelona), , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
La Roca Del Valles (Barcelona), , Spain
GSK Investigational Site
Loja/ Granada, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Peralada( Girona), , Spain
GSK Investigational Site
Aylesbury, Buckinghamshire, United Kingdom
GSK Investigational Site
Wigan, Lancashire, United Kingdom
GSK Investigational Site
Wellingborough, Northamptonshire, United Kingdom
GSK Investigational Site
Addlestone, Surrey, United Kingdom
GSK Investigational Site
Rotherham, Yorkshire, United Kingdom
GSK Investigational Site
Bristol, , United Kingdom
GSK Investigational Site
Chelmsford, , United Kingdom
GSK Investigational Site
Chertsey, Surrey, , United Kingdom
GSK Investigational Site
Harrogate, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-002266-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
207040
Identifier Type: -
Identifier Source: org_study_id
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