Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Adherence, Dose Tracking, Concept2, Digital Adherence System, Ultibro Breezhaler
Brief 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. 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.
Interventions
COMBINATION_PRODUCTConcept2 inhaler
Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler
COMBINATION_PRODUCTConcept2 inhaler with patient application
Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler with application used for monitoring
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participant's On-time Adherence Over 24 Weeks of Intervention Compared to Baseline | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Participant's 6 Weeks Baseline On-time Adherence to the Participant's On-time Adherence Over the Last Four Weeks of Intervention | Baseline, Week 21 - 24 | 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 From Participant's 6 Weeks Baseline Total Adherence to the Participant's Total Adherence Over the Last Four Weeks of Intervention | Baseline, Week 21 - 24 | 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. |
Countries
Germany, Netherlands
Participant flow
Recruitment details
This study was conducted at Netherlands and Germany between 11 July 2018 (first participant first visit) and 22 January 2019 (last participant last visit).
Pre-assignment details
A total of 7 subjects were randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Usual Care Group Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks. | 6 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Technical issues with Concept 2 inhalers | 1 | 6 |
Baseline characteristics
| Characteristic | Total | Telehealth Group | Usual Care Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 1 Participants | 6 Participants |
| Region of Enrollment Germany | 4 participants | 0 participants | 4 participants |
| Region of Enrollment Netherlands | 3 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 6 |
| other Total, other adverse events | 0 / 1 | 2 / 6 |
| serious Total, serious adverse events | 0 / 1 | 0 / 6 |
Outcome results
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.
Time frame: Baseline 6 weeks, intervention 24 weeks
Population: 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.
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.
Time frame: Baseline 6 weeks, intervention 24 weeks
Population: 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.
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.
Time frame: Baseline, Week 21 - 24
Population: 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.
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.
Time frame: Baseline, Week 21 - 24
Population: 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.