AzTrials
AzTrials

AsthmaPhase 4NCT03380429

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

A Phase 4 study testing RELVAR/BREO, Salbutamol and Smart phone app in people with Asthma, run by GlaxoSmithKline at 66 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
RELVAR/BREO, Salbutamol and Smart phone app
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
437 participants
Where
66 sitesin 7 countries
Study dates
31 Jan 2018to 24 Jan 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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).

Who cannot join

  • 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.
Show all 9Show fewer
  • 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 locations and contacts

66 sites in 7 countries.

66 sites in 7 countries

Canada16 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Kelowna, British Columbia, V1W 1V3

  • GSK Investigational Site

    London, Ontario, N5W 6A2

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Québec, Quebec, G1N 4V3

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Québec, Quebec, G3K 2P8

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    Sherbrooke, Quebec, J1L 0H8

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Toronto, Ontario, M9V 4B4

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • GSK Investigational Site

    Victoriaville, Quebec, G6P 6P6

  • GSK Investigational Site

    Windsor, Ontario, N8X2G1

Other trials in Canada

United States11 sites

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Charlotte, North Carolina, 28277

  • GSK Investigational Site

    Flossmoor, Illinois, 60422

  • GSK Investigational Site

    Glenview, Illinois, 60026

  • GSK Investigational Site

    Greenfield, Wisconsin, 53228

  • GSK Investigational Site

    Hazelwood, Missouri, 63042

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 33173

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Richmond, Virginia, 23230

  • GSK Investigational Site

    San Antonio, Texas, 78229

Other trials in United States

Germany10 sites

  • GSK Investigational Site

    Berlin, 10119

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Berlin, 13156

  • GSK Investigational Site

    Berlin, 14059

  • GSK Investigational Site

    Darmstadt, Hesse, 64283

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

  • GSK Investigational Site

    Warendorf, North Rhine-Westphalia, 48231

Other trials in Germany

Spain9 sites

  • GSK Investigational Site

    A Coruña, 15011

  • GSK Investigational Site

    Balenyà (Barcelona), 08550

  • GSK Investigational Site

    Barcelona, 08028

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    La Roca Del Valles (Barcelona), 08430

  • GSK Investigational Site

    Loja/ Granada, 18300

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28044

  • GSK Investigational Site

    Peralada( Girona), 17491

Other trials in Spain

United Kingdom9 sites

  • GSK Investigational Site

    Addlestone, Surrey, KT15 2BH

  • GSK Investigational Site

    Aylesbury, Buckinghamshire, HP21 8AL

  • GSK Investigational Site

    Bristol, BS37 4AX

  • GSK Investigational Site

    Chelmsford, CM1 7ET

  • GSK Investigational Site

    Chertsey, Surrey, KT16 0PZ

  • GSK Investigational Site

    Harrogate, HG2 7SX

  • GSK Investigational Site

    Rotherham, Yorkshire, S65 1DA

  • GSK Investigational Site

    Wellingborough, Northamptonshire, NN8 4RW

  • GSK Investigational Site

    Wigan, Lancashire, WN1 2NN

Other trials in United Kingdom

Netherlands6 sites

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Groningen, 9728 NT

  • GSK Investigational Site

    Hengelo, 7555 DL

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    The Hague, 2526 HW

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

Italy5 sites

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Palermo, Sicily, 90146

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Pordenone, Friuli Venezia Giulia, 33170

  • GSK Investigational Site

    Salerno, Campania, 84131

Other trials in Italy

About this study

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

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.

Conditions
Asthma
Being tested
RELVAR/BREO, Salbutamol, Smart phone app, HCP Dashboard, Sensors
Keywords
Connected Inhaler System, Metered Dose Inhaler, ELLIPTA, RELVAR/BREO, Dry Powder Inhaler, Salbutamol, Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RELVAR/BREODrug

    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.

  • SalbutamolDrug

    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 appDevice

    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 DashboardDevice

    The information from sensors will be reviewed by the HCP via an online dashboard.

  • SensorsDevice

    Clip-on sensors will be fitted to electronically record the actuation data.

Study groups in NCT03380429
Study groupRoleWhat they receive
Data on Maintenance use supplied to Subject and HCPExperimentalEligible 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.
Receives: Drug: RELVAR/BREO; Drug: Salbutamol; Device: Smart phone app; Device: HCP Dashboard; Device: Sensors
Data on Maintenance use supplied to SubjectExperimentalEligible 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.
Receives: Drug: RELVAR/BREO; Drug: Salbutamol; Device: Smart phone app; Device: Sensors
Data on Maintenance and Rescue use supplied to Subject and HCPExperimentalEligible 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.
Receives: Drug: RELVAR/BREO; Drug: Salbutamol; Device: Smart phone app; Device: HCP Dashboard; Device: Sensors
Data on Maintenance and Rescue use supplied to SubjectExperimentalEligible 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.
Receives: Drug: RELVAR/BREO; Drug: Salbutamol; Device: Smart phone app; Device: Sensors
No data supplied to Subject or HCPActive 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.
Receives: Drug: RELVAR/BREO; Drug: Salbutamol; Device: Sensors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Month 4 to Month 6

Secondary outcomes (9)

  1. Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor

    Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 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. 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 effect on daily adherence to maintenance therapy when maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.

    Measured: Month 4 to Month 6

  2. Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor

    Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 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. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 3 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.

    Measured: Month 1 to Month 3

  3. Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor

    Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 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. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 6 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.

    Measured: Month 1 to Month 6

  4. Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor

    Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Percentage of rescue free days were determined by the rescue sensor records of date, time and number of inhaler actuations. Least Square mean percentage of rescue free days between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.

    Measured: Month 4 to Month 6

  5. Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor

    Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Total rescue use was determined by the rescue sensor records of date, time and number of inhaler actuations. The mean number of doses of rescue medicines between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.

    Measured: Month 4 to Month 6

  6. Change From Baseline in Asthma Control Test (ACT) Total Score

    The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Change from Baseline was calculated as post-dose visit value minus the Baseline value.

    Measured: Baseline and Month 6

  7. Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6

    Percentage of participants attaining asthma control was defined as participants with an ACT total score >=20 at Month 6. The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Percentage of participants who attained asthma control at Month 6 is presented.

    Measured: Month 6

  8. Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6

    The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants with an increase from Baseline >=3 in ACT total score at Month 6 is presented.

    Measured: Baseline and Month 6

  9. 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

    The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants who had either an ACT total score of >=20 and/or an increase from Baseline >=3 in ACT total score at Month 6 is presented.

    Measured: Baseline and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2017
  2. Study start31 Jan 2018
  3. Primary completion24 Jan 2019
  4. Study completion24 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI. Clip-on sensors will be attached to both inhalers which will provide data on maintenance therapy and rescue medication use to the subjects and their HCP. Subjects will be randomized into five treatment arms in a ratio of 1:1:1:1:1 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.
Masking
None (open label)
Enrolment
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03380429
Sponsor's protocol ID
207040
Other IDs
2017-002266-45, 2017
Status last verified
Mar 2021
First submitted
15 Dec 2017
Last updated
12 Apr 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site.

Publications

  • 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.

    PubMed 33334936

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing RELVAR/BREO, Salbutamol and Smart phone app in people with Asthma, run by GlaxoSmithKline at 66 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Canada, United States, Germany, Spain, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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") (time frame: Month 4 to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03380429, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT03380429 | AzTrials