Phase 4
Completed N=437
A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
Source: ClinicalTrials.gov NCT03380429 ↗Enrolled (actual)
437
Serious AEs
2.3%
Results posted
Feb 2020
Primary outcomePrimary: 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") — 80.9; 69.0 Percentage of ELLIPTA doses — p=<0.001
◆ Published Evidence
Established
64citations · ~13 / year
A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients.
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.
Linked Publications
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A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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") |
80.9; 69.0 | <0.001 sig |
| SECONDARY Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor |
77.2; 78.3; 77.1; 69.0 | 0.016 sig |
| SECONDARY Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor |
85.7; 84.2; 82.0; 79.2; 76.4 | 0.003 sig |
| SECONDARY Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor |
81.5; 78.8; 77.7; 75.2; 71.8 | 0.004 sig |
| SECONDARY Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor |
81.1; 81.2; 85.6; 83.7; 76.4 | 0.118 |
| SECONDARY Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor |
55.3; 40.6; 29.5; 27.0; 55.8 | — |
| SECONDARY Change From Baseline in Asthma Control Test (ACT) Total Score |
3.4; 4.3; 4.7; 4.2; 3.9 | 0.400 |
| SECONDARY Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6 |
52; 66; 55; 53; 62 | 0.385 |
| SECONDARY Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6 |
61; 69; 65; 63; 64 | 0.911 |
| SECONDARY Percentage of Participants Who Have Either an ACT Total Score of >=20 and/or an Increase From Baseline >=3 in ACT Total Score at Month 6 |
66; 75; 65; 67; 70 | 0.833 |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03380429) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.