A Phase 3 interventional study of Concept2 inhaler and Concept2 inhaler with patient application in Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals. Terminated at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Device feasibility
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Among 117 studies in Pulmonary Disease, Chronic Obstructive by Novartis — none open to participants now, none under way, none of them phase 3. Pulmonary Disease, Chronic Obstructive · Novartis.
Among the 117 studies in Pulmonary Disease, Chronic Obstructive by Novartis, this one is the 108th largest by enrollment of the 116 interventional ones that give a count, is the only one that started in 2018, is one of 59 in phase 3, and was the 113th registered.
5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →None of the 117 studies in Pulmonary Disease, Chronic Obstructive by Novartis is open now. The open studies under Pulmonary Disease, Chronic Obstructive, anywhere →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
117 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 26 · Phase 3 61 · Phase 4 24
First in 2003; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 is below the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 203 across the 116 interventional studies, 103 across the 1 observational. Of the 110 that completed or were terminated, 94 (85%) have results posted.
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This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 117 studies in Pulmonary Disease, Chronic Obstructive by Novartis, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Concept2 inhaler
Combination Product: Concept2 inhaler
Concept2 inhaler with patient application
Combination Product: Concept2 inhaler with patient application
Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler
Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler with application used for monitoring
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
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
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
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
This study was conducted at Netherlands and Germany between 11 July 2018 (first participant first visit) and 22 January 2019 (last participant last visit).
| Milestone | Telehealth Group | Usual Care Group |
|---|---|---|
| Started | 1 | 6 |
| Completed | 0 | 0 |
| Not completed | 1 | 6 |
| Withdrew: Technical issues with concept 2 inhalers | 1 | 6 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Treatment emergent adverse events were reported from start of treatment up to follow up (34 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telehealth Group | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Usual Care Group | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Event | Telehealth Group | Usual Care Group |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 0/1 | 2/6 |
| Respiratory tract infectionInfections and infestations | 0/1 | 1/6 |
Randomized set consisted of all participants who were randomized to one of the interventions (Telehealth group or Usual Care group).
| Age, Categorical(Participants) | Telehealth Group | Usual Care Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 2 | 3 |
| >=65 years | 0 | 4 | 4 |
| Sex: Female, Male(Participants) | Telehealth Group | Usual Care Group | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 0 | 4 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Telehealth Group | Usual Care Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 6 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Telehealth Group | Usual Care Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 6 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Telehealth Group | Usual Care Group | Total |
|---|---|---|---|
| Netherlands | 1 | 2 | 3 |
| Germany | 0 | 4 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Jan 2019, 6 months.
Results were first posted in Jan 2020, 1 year after primary completion.
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This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →