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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Concept2 inhaler |
|
| Telehealth | Experimental | Concept2 inhaler with patient application |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concept2 inhaler | Combination Product | Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline 6 weeks, intervention 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | 12203 | Germany | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
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A total of 7 subjects were randomized in the study.
This study was conducted at Netherlands and Germany between 11 July 2018 (first participant first visit) and 22 January 2019 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Telehealth Group | Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks. |
| FG001 | Usual Care Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2018 | Jan 15, 2020 |
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| Concept2 inhaler with patient application | Combination Product | Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler with application used for monitoring |
|
| 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. | Baseline, Week 21 - 24 |
| Hamburg |
| 20354 |
| Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Heerlen | 6419 PC | Netherlands |
| Novartis Investigative Site | Helmond | 5707 HA | Netherlands |
| Novartis Investigative Site | Leeuwarden | 8934 AD | Netherlands |
| Novartis Investigative Site | Zutphen | 7207 AE | Netherlands |
Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks. |
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| NOT COMPLETED |
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Randomized set consisted of all participants who were randomized to one of the interventions (Telehealth group or Usual Care group).
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| ID | Title | Description |
|---|---|---|
| BG000 | Telehealth Group | Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks. |
| BG001 | Usual Care Group | Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Due to technical issues, the actual time and day of inhaler use from the point of resetting could not be evaluated. Therefore data for this outcome measure were not collected and reported. | Posted | Baseline 6 weeks, intervention 24 weeks |
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| Primary | 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. | Due to technical issues, the actual time and day of inhaler use from the point of resetting could not be evaluated. Therefore data for this outcome measure were not collected and reported. | Posted | Baseline 6 weeks, intervention 24 weeks |
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| Secondary | 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. | Due to the early discontinuation of the study, only very few participants were randomized (7) and no participant completed the last 4 weeks of intervention, required for the evaluation of the secondary efficacy outcome measure. Therefore data for this outcome measure was not collected and reported. | Posted | Baseline, Week 21 - 24 |
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| Secondary | 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. | Due to the early discontinuation of the study, only very few participants were randomized (7) and no participant completed the last 4 weeks of intervention, required for the evaluation of the secondary efficacy outcome measure. Therefore data for this outcome measure was not collected and reported. | Posted | Baseline, Week 21 - 24 |
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Treatment emergent adverse events were reported from start of treatment up to follow up (34 weeks)
Enrolled set consisted of participants who signed informed consent and had some assessment done in the screening period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telehealth Group | Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | Usual Care Group | Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks. | 0 | 6 | 0 | 6 | 2 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
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The study was prematurely terminated due to technical issues with the investigational Concept2 inhalers. Due to limited and inaccurate data, efficacy endpoints with respect to change in on-time and total treatment adherence were not evaluated.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2018 | Jan 15, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Germany |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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