Last updated: 03/17/2021 07:50:11
A clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to maintenance therapy in poorly controlled asthmatic subjects
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Percentage of ELLIPTA doses taken between months 4 and 6
Timeframe: Month 4 and up to Month 6
Secondary outcomes:
Percentage of ELLIPTA doses taken between months 4 and 6
Timeframe: Month 4 and up to Month 6
Percentage of ELLIPTA doses taken between months 1 and 3
Timeframe: Month 1 and up to Month 3
Percentage of ELLIPTA doses taken between months 1 and 6
Timeframe: Month 1 and up to Month 6
Percentage of rescue free days
Timeframe: Month 4 and up to Month 6
Total rescue medication use
Timeframe: Month 4 and up to Month 6
Change from Baseline in Asthma Control Test (ACT) total score
Timeframe: Baseline and Month 6
Percentage of subjects attaining asthma control
Timeframe: Month 6
Percentage of subjects with an increase from Baseline >=3 in ACT total score
Timeframe: Baseline and Month 6
Interventions:
Enrollment:
437
Primary completion date:
2019-24-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
January 2018 to January 2019
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Addlestone, Surrey, United Kingdom, KT15 2BH
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28277
Status
Study Complete
Location
GSK Investigational Site
Chertsey, Surrey, United Kingdom, KT16 0PZ
Status
Study Complete
Location
GSK Investigational Site
Flossmoor, Illinois, United States, 60422
Status
Study Complete
Location
GSK Investigational Site
Glenview, Illinois, United States, 60026
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
Status
Study Complete
Location
GSK Investigational Site
Hazelwood, Missouri, United States, 63042
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1W 1V3
Status
Study Complete
Location
GSK Investigational Site
La Roca del Valles (Barcelona), Spain, 08430
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Pordenone, Friuli-Venezia-Giulia, Italy, 33170
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23230
Status
Study Complete
Location
GSK Investigational Site
Rotherham, Yorkshire, United Kingdom, S65 1DA
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Status
Study Complete
Location
GSK Investigational Site
Victoriaville, Québec, Canada, G6P 6P6
Status
Study Complete
Location
GSK Investigational Site
Warendorf, Nordrhein-Westfalen, Germany, 48231
Status
Study Complete
Location
GSK Investigational Site
Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
Status
Study Complete
Location
GSK Investigational Site
Wigan, Lancashire, United Kingdom, WN1 2NN
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2019-24-01
Actual study completion date
2019-24-01
Plain language summaries
Summary of results in plain language
Available language(s): English, German, Spanish, Spanish (United States), French (Canadian), Italian, Dutch
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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