Chronic Obstructive Pulmonary DiseasePhase 3ADVICENCT03379233
A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence
A Phase 3 study testing Concept2 inhaler and Concept2 inhaler with patient application in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 9 sites in 2 countries.
Trial summary
This study was evaluating the effect of reminder notifications and motivational/adaptive messages on treatment adherence behavior in subjects with COPD. The effect will be measured over 24 weeks on the subject's on time treatment adherence and total treatment adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Concept2 inhaler and Concept2 inhaler with patient application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 11 Jul 2018to 22 Jan 2019
- Phase
- Phase 3
- 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
- Signed informed consent
- Have a total adherence of more than 10% but less than or equal to 70% during Screening period
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- A diagnosed COPD
- Taking Ultibro® Breezhaler® for at least 3 month prior to Visit 1
- Have been in the Screening period ≥ 35 days.
Who cannot join
- Pregnant or lactating women
- Women of child-bearing potential
- Subjects having a history of reactions/hypersensitivity to inhaled drugs or drugs of a similar class
- Subjects having a history of reactions/hypersensitivity to lactose or any of the other ingredients of trial medication.
- Subjects with relevant concomitant diseases
- Subjects who have had a COPD exacerbation 6 weeks prior to Visit 1 or between V1 and randomization
Show all 13Show fewer
- Subjects who have had a respiratory tract infection within 3 weeks prior to Visit 1 or between V1 and randomization
- Use of investigational drugs or other investigational devices at the time of enrollment
- Subjects with a preferred inhalation time between 10.00 pm and 2.00 am.
- Subjects taken off Ultibro® Breezhaler® treatment/inhaler use by the investigator during the Screening period for more than 7 days.
- Subjects not returning all Concept2 inhalers received during the Screening period
- Subjects who have demonstrated inability or unwillingness to use the digital system or to fill in questionnaires.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany5 sites
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Lübeck, 23552
Netherlands4 sites
Novartis Investigative Site
Heerlen, 6419 PC
Novartis Investigative Site
Helmond, 5707 HA
Novartis Investigative Site
Leeuwarden, 8934 AD
Novartis Investigative Site
Zutphen, 7207 AE
About this study
Official title: A 24-week Randomized, Controlled, Multicenter, Open-label Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence of COPD Subjects Receiving Ultibro® Breezhaler® Treatment Using the Concept2 Inhaler for Dose Administration and Tracking
This study was evaluating the effect of reminder notifications and motivational/adaptive messages on treatment adherence behavior in subjects with COPD. The effect will be measured over 24 weeks on the subject's on time treatment adherence and total treatment adherence. The delivery of the medication and tracking of inhaler use is done by the Concept2 inhaler. The reminder notification, feedback on inhaler use and motivational messages are provided by the patient application, who is receiving the inhaler use information from the Concept2 inhaler.
Read the detailed description
This study was evaluating whether subjects with COPD on Ultibro® Breezhaler® clinical trial formulation once daily dosing regimen using the Concept2 inhaler in conjunction with a patient application collecting data and sending reminder notifications and motivational/adaptive messages aimed at encouraging treatment adherence, have improved treatment adherence compared to subjects using the Concept2 inhaler alone (usual care). The delivery of the medication and tracking of inhaler use is done by the Concept2 inhaler. The reminder notifications, feedback on inhaler use and motivational messages for the subject are sent by the patient application based on the received subjects inhaler use information from the Concept2 inhaler.
The effect will be measured over 24 weeks on the subject's on time treatment adherence (days when the subjects inhaled within +/- 2 hours of the subjects preferred inhalation time) and total treatment adherence (days when patient inhaled at least one dose).
The study population consisted male and female adult patients, 18 years or older with a clinical diagnosis of COPD, a smoking history of 10 pack years, receiving Ultibro Breezhaler treatment for at least 3 months prior to screening and documented poor treatment adherence.
After 6 weeks of screening patients will be randomized to either the Usual Care group in which they will continue to receive Ultibro Breezhaler treatment via the Concept2, or the Telehealth group in which they will additionally receive a tablet device pre-installed with a patient app.
In addition to on time treatment adherence and total treatment adherence, illness and treatment beliefs will be collected via a questionnaire and patient's health status from the EQ5D-5L and SGRQ-C Questionnaire. Key safety assessments are COPD exacerbation and AE/SAE, device deficiencies and device events, drug administration errors, physical exam, vital signs and urine or serum pregnancy test.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Concept2 inhaler, Concept2 inhaler with patient application
- Keywords
- Chronic Obstructive Pulmonary Disease, Adherence, Dose Tracking, Concept2, Digital Adherence System, Ultibro Breezhaler
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concept2 inhalerCombination product
Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler
Concept2 inhaler with patient applicationCombination product
Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler with application used for monitoring
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Concept2 inhaler Receives: Combination Product: Concept2 inhaler |
| Telehealth | Experimental | Concept2 inhaler with patient application Receives: Combination Product: Concept2 inhaler with patient application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Participant's On-time Adherence Over 24 Weeks of Intervention Compared to Baseline
On-time treatment adherence was defined as percentage of days on which the participant inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed predefined preferred daily inhalation time (PIT). PIT was defined by the participant at study start.
Measured: Baseline 6 weeks, intervention 24 weeks
Change in Participant's Total Adherence Over 24 Weeks of Intervention Compared to Baseline
Total adherence was defined as percentage of days on which the participant inhaled at least one dose and represented the sum of on-time adherence and off-time adherence. Off-time adherence was defined as percentage of days on which the participant did not inhale the daily dose within the (+ or -) 2 hours of the predefined PIT, but outside. The number of doses not inhaled on-time was recorded by the Concept2 inhaler.
Measured: Baseline 6 weeks, intervention 24 weeks
Secondary outcomes (2)
Change From Participant's 6 Weeks Baseline On-time Adherence to the Participant's On-time Adherence Over the Last Four Weeks of Intervention
On-time treatment adherence was defined as percentage of days on which the participant inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed predefined preferred daily inhalation time (PIT). PIT was defined by the participant at study start.
Measured: Baseline, Week 21 - 24
Change From Participant's 6 Weeks Baseline Total Adherence to the Participant's Total Adherence Over the Last Four Weeks of Intervention
Total adherence was defined as percentage of days on which the participant inhaled at least one dose and represented the sum of on-time adherence and off-time adherence. Off-time adherence was defined as percentage of days on which the participant did not inhale the daily dose within the (+ or -) 2 hours of the predefined PIT, but outside. The number of doses not inhaled on-time was recorded by the Concept2 inhaler.
Measured: Baseline, Week 21 - 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start11 Jul 2018
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Why it stopped: devices malfunctioned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379233
- Sponsor's protocol ID
- CIDD001D2402
- Acronym
- ADVICE
- Status last verified
- Jan 2020
- First submitted
- 15 Dec 2017
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Randomized, Controlled, Multicenter, Open-label Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence of COPD Subjects Receiving Ultibro® Breezhaler® Treatment Using the Concept2 Inhaler for Dose Administration and Tracking
- ClinicalTrials.gov ID
- NCT03379233
- Acronym / sponsor ID
- ADVICE / CIDD001D2402
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Adherence, Dose Tracking, Concept2, Digital Adherence System, Ultibro Breezhaler
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: devices malfunctioned
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was evaluating the effect of reminder notifications and motivational/adaptive messages on treatment adherence behavior in subjects with COPD. The effect will be measured over 24 weeks on the subject's on time treatment adherence and total treatment adherence. The delivery of the medication and tracking of inhaler use is done by the Concept2 inhaler. The reminder notification, feedback on inhaler use and motivational messages are provided by the patient application, who is receiving the inhaler use information from the Concept2 inhaler.
Detailed description
This study was evaluating whether subjects with COPD on Ultibro® Breezhaler® clinical trial formulation once daily dosing regimen using the Concept2 inhaler in conjunction with a patient application collecting data and sending reminder notifications and motivational/adaptive messages aimed at encouraging treatment adherence, have improved treatment adherence compared to subjects using the Concept2 inhaler alone (usual care). The delivery of the medication and tracking of inhaler use is done by the Concept2 inhaler. The reminder notifications, feedback on inhaler use and motivational messages for the subject are sent by the patient application based on the received subjects inhaler use information from the Concept2 inhaler.
The effect will be measured over 24 weeks on the subject's on time treatment adherence (days when the subjects inhaled within +/- 2 hours of the subjects preferred inhalation time) and total treatment adherence (days when patient inhaled at least one dose).
The study population consisted male and female adult patients, 18 years or older with a clinical diagnosis of COPD, a smoking history of 10 pack years, receiving Ultibro Breezhaler treatment for at least 3 months prior to screening and documented poor treatment adherence.
After 6 weeks of screening patients will be randomized to either the Usual Care group in which they will continue to receive Ultibro Breezhaler treatment via the Concept2, or the Telehealth group in which they will additionally receive a tablet device pre-installed with a patient app.
In addition to on time treatment adherence and total treatment adherence, illness and treatment beliefs will be collected via a questionnaire and patient's health status from the EQ5D-5L and SGRQ-C Questionnaire. Key safety assessments are COPD exacerbation and AE/SAE, device deficiencies and device events, drug administration errors, physical exam, vital signs and urine or serum pregnancy test.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Combination Product: Concept2 inhalerConcept2 inhaler |
| Telehealth | Experimental | Combination Product: Concept2 inhaler with patient applicationConcept2 inhaler with patient application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Have a total adherence of more than 10% but less than or equal to 70% during Screening period
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- A diagnosed COPD
- Taking Ultibro® Breezhaler® for at least 3 month prior to Visit 1
Key exclusion criteria (13 listed)
- Pregnant or lactating women
- Women of child-bearing potential
- Subjects having a history of reactions/hypersensitivity to inhaled drugs or drugs of a similar class
- Subjects having a history of reactions/hypersensitivity to lactose or any of the other ingredients of trial medication.
- Subjects with relevant concomitant diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concept2 inhalerFixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler | Combination product | Usual Care |
| Concept2 inhaler with patient applicationFixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler with application used for monitoring | Combination product | Telehealth |
Primary outcome
Change in Participant's On-time Adherence Over 24 Weeks of Intervention Compared to Baseline
Time frame: Baseline 6 weeks, intervention 24 weeks
On-time treatment adherence was defined as percentage of days on which the participant inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed predefined preferred daily inhalation time (PIT). PIT was defined by the participant at study start.
Change in Participant's Total Adherence Over 24 Weeks of Intervention Compared to Baseline
Time frame: Baseline 6 weeks, intervention 24 weeks
Total adherence was defined as percentage of days on which the participant inhaled at least one dose and represented the sum of on-time adherence and off-time adherence. Off-time adherence was defined as percentage of days on which the participant did not inhale the daily dose within the (+ or -) 2 hours of the predefined PIT, but outside. The number of doses not inhaled on-time was recorded by the Concept2 inhaler.
2 secondary outcomes
Change From Participant's 6 Weeks Baseline On-time Adherence to the Participant's On-time Adherence Over the Last Four Weeks of Intervention
Time frame: Baseline, Week 21 - 24
Change From Participant's 6 Weeks Baseline Total Adherence to the Participant's Total Adherence Over the Last Four Weeks of Intervention
Time frame: Baseline, Week 21 - 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Concept2 inhaler and Concept2 inhaler with patient application in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 9 sites in 2 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 27 Jan 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?
Change in Participant's On-time Adherence Over 24 Weeks of Intervention Compared to Baseline (time frame: Baseline 6 weeks, intervention 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021.