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



Status:Completed
Conditions:Asthma, Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:January 31, 2018
End Date:January 24, 2019

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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

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.


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.
We found this trial at
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Oklahoma City, Oklahoma 73112
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Aventura, Florida 33180
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Charlotte, North Carolina 28203
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Evanston, Illinois 60201
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Flossmoor, Illinois 60422
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Greenfield, Wisconsin 53228
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Hazelwood, Missouri 63042
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Kelowna, British Columbia
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Medford, Oregon 97504
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Medford, OR
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Miami, Florida 33136
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Richmond, Virginia 23298
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San Antonio, Texas 78258
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