AsthmaADITIONNCT04656223
Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
An observational study of Asthma, run by Novartis Pharmaceuticals at 26 sites in Germany.
Trial summary
This study is designed as a multicenter, observational, non-interventional, open label, 26-week study in order to observe how asthma control changes under treatment with Mometasone Fuorat/Indacaterol/ Glycopyrronium (MF/IND/GLY) Breezhaler® sensor system or under treatment with fixed-dose combination (FDC) triple… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma
- What is being tested?
- MF/IND/GLY plus sensor system and FDC therapy
- How many people
- 434 participants
- Where
- 26 sitesGermany
- Study dates
- 17 Dec 2020to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled from approximately 25 pulmonology centers across Germany.
Who may be able to join
- To participate in the study, all of the following inclusion criteria must be met:
- Patients (m/f/d) at the age of ≥18
- Written declaration of consent
- Asthma diagnosis according to German Asthma Guideline NVL, 4th edition
- Suitability for a therapy with MF/IND/GLY in combination with the sensor system or another ICS+LABA+LAMA FDC according to SPC
- At least 6 months of inhaled therapy with ICS+LABA (high dose) or ICS+LABA+LAMA (medium or high dose) before switching or escalating asthma medication at baseline
Show all 11Show fewer
- Change or escalation of the asthma medication to MF/IND/GLY in combination with the sensor system or another ICS+LABA+LAMA FDC according to the therapy decision of the treating physician
- Availability of at least one ACT value of the last 6 months before consent
- Cohort treated with MF/IND/GLY in combination with the sensor system
- Owning an Android or iOS smartphone or tablet on which the app can be installed (via WiFi or mobile data network) and run (requires about 75 megabytes of storage space) and which is capable of establishing a Bluetooth connection to the sensor The patient must agree to activate the app, the Bluetooth connection and the mobile data connection regularly (at least once a month).
- Availability of an e-mail address
Who cannot join
- To participate in the study, none of the following exclusion criteria must apply:
- Use of a digital inhaler-coupled inhalation tracking system to support adherence in the last 3 months prior to study entry
- Simultaneous participation in an interventional study or in another Novartis-sponsored noninterventional study
- Asthma therapy with a biological agent, if not stable at the same dosage for at least 3 months
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Germany26 sites
Novartis Investigative Site
Ansbach, 91522
Novartis Investigative Site
Aschaffenburg, 63739
Novartis Investigative Site
Augsburg, 86150
Novartis Investigative Site
Bad Sachsa, 37441
Novartis Investigative Site
Berlin, 12099
Novartis Investigative Site
Berlin, 12672
Novartis Investigative Site
Berlin, 13125
Novartis Investigative Site
Berlin, 13187
Novartis Investigative Site
Braunschweig, Lower Saxonia, 38100
Novartis Investigative Site
Burgwedel, 30938
Novartis Investigative Site
Einbeck, 37574
Novartis Investigative Site
Fürstenwalde, 15517
Novartis Investigative Site
Göttingen
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hanover, Lower Saxonia, 30449
Novartis Investigative Site
Hanover, 30163
Novartis Investigative Site
Ibbenbueren, Rhineland-Palatinate, 49477
Novartis Investigative Site
Leipzig, Saxony, 04107
Novartis Investigative Site
Leipzig, 04157
Novartis Investigative Site
Leipzig, D-04347
Novartis Investigative Site
Marburg, 35037
Novartis Investigative Site
Markkleeberg, 04416
Novartis Investigative Site
Papenburg, 26871
Novartis Investigative Site
Radebeul, 01445
Novartis Investigative Site
Ulm, Baden-Wurttemberg, 89073
Novartis Investigative Site
Wiesbaden, 65183
About this study
This study is designed as a multicenter, observational, non-interventional, open label, 26-week study in order to observe how asthma control changes under treatment with Mometasone Fuorat/Indacaterol/ Glycopyrronium (MF/IND/GLY) Breezhaler® sensor system or under treatment with fixed-dose combination (FDC) triple therapy after 26 weeks of treatment.
Read the detailed description
Subjects in one group will receive MF/IND/GLY together with the Propeller add-on sensor for the Breezhaler® and access to the smartphone app according to label. Subjects in the other group will receive any triple FDC according to label. The physician's decision to initiate or switch a patient to MF/IND/GLY Breezhaler® system or any other triple FDC must have been taken prior to and independently from the decision to include the patient in the study.
- Conditions
- Asthma
- Being tested
- MF/IND/GLY plus sensor system, FDC therapy
- Keywords
- mobile Health, mHealth, Propeller Health, MF/IND/GLY Breezhaler®, FDC, Fixed dose combination, Mometasone Fuorat, Indacaterol, Glycopyrronium
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF/IND/GLY plus sensor systemCombination product
There is no treatment allocation. Patients administered MF/IND/GLY plus sensor system by prescription that have started before inclusion of the patient into the study will be enrolled.
Subjects will receive MF/IND/GLY together with the Propeller add-on sensor for the Breezhaler® according to label.
FDC therapyDrug
There is no treatment allocation. Patients administered FDC therapy by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| MF/IND/GLY Breezhaler® plus Propeller Health | patients receiving MF/IND/GLY Breezhaler® plus electronic inhalation tracking sensor (Propeller Health) according to label Receives: Combination Product: MF/IND/GLY plus sensor system | |
| Other FDC therapy | patients receiving ICS+LABA+LAMA FDC therapy according to label Receives: Drug: FDC therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asthma control test (ACT) score
ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control.
It is a self-administered questionnaire comprising five items that are assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'controlled asthma', a score of 16-19 denoting 'partially controlled asthma', and a score of <=15 denoting 'uncontrolled asthma'. The total score is calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control.
Measured: Baseline, week 26
Secondary outcomes (10)
Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician
Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician will be provided
Measured: Baseline
Description of of patient characteristics at baseline
Description of patient characteristics at baseline in the treatment groups receiving MF/IND/GLY plus sensor or triple FDC will be provided
Measured: Baseline
Percentage of patients showing an improvement in self-reported test adherence to inhalers (TAI) questionnaire
TAI test is a 12-item questionnaire designed to assess the adherence to inhalers in patients with asthma.
Ten questions are answered by the patients, and have to rate each question from 1 to 5. Total score can go between 10 and 50; 50 points correlates to "adherent", 46-49 points correlates to "moderate adherent" and lower than 45 points correlate to "not adherent".
Two additional questions are answered by the physician
Measured: 26 weeks
Course of adherence in the subgroup receiving MF/IND/GLY plus sensor
Adherence course according to inhalation tracking data in the subgroup treated with MF/IND/GLY plus sensor will be provided
Measured: 26 weeks
Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor
Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor will be provided
Measured: 26 weeks
Percentage of patients achieving the minimal clinically important difference (MCID) change
Percentage of patients achieving the minimal clinically important difference (MCID) change from baseline ACT ≥ 3 points will be provided
Measured: Baseline, week 26
Percentage of patients with an ACT score <19
Percentage of patients with an ACT score of <19 at baseline and following 26 weeks will be provided
Measured: 26 weeks
Change in Post-dose trough Forced Expiratory Volume in one second (FEV1)
FEV 1 it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible.
Measured: Baseline, week 26
Change in Forced vital capacity (FVC)
FVC is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
Measured: Baseline, week 26
Adverse events
Adverse events will be provided
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start17 Dec 2020
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 434 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
- NCT04656223
- Sponsor's protocol ID
- CQVM149BDE01
- Acronym
- ADITION
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2020
- Last updated
- 25 Mar 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
- ClinicalTrials.gov ID
- NCT04656223
- Acronym / sponsor ID
- ADITION / CQVM149BDE01
- Conditions
- Asthma
- Keywords
- mobile Health, mHealth, Propeller Health, MF/IND/GLY Breezhaler®, FDC, Fixed dose combination, Mometasone Fuorat, Indacaterol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a multicenter, observational, non-interventional, open label, 26-week study in order to observe how asthma control changes under treatment with Mometasone Fuorat/Indacaterol/ Glycopyrronium (MF/IND/GLY) Breezhaler® sensor system or under treatment with fixed-dose combination (FDC) triple therapy after 26 weeks of treatment.
Detailed description
Subjects in one group will receive MF/IND/GLY together with the Propeller add-on sensor for the Breezhaler® and access to the smartphone app according to label. Subjects in the other group will receive any triple FDC according to label. The physician's decision to initiate or switch a patient to MF/IND/GLY Breezhaler® system or any other triple FDC must have been taken prior to and independently from the decision to include the patient in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MF/IND/GLY Breezhaler® plus Propeller Health | – | Combination Product: MF/IND/GLY plus sensor systempatients receiving MF/IND/GLY Breezhaler® plus electronic inhalation tracking sensor (Propeller Health) according to label |
| Other FDC therapy | – | Drug: FDC therapypatients receiving ICS+LABA+LAMA FDC therapy according to label |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled from approximately 25 pulmonology centers across Germany.
Key inclusion criteria (11 listed)
- Patients (m/f/d) at the age of ≥18
- Written declaration of consent
- Asthma diagnosis according to German Asthma Guideline NVL, 4th edition
- Suitability for a therapy with MF/IND/GLY in combination with the sensor system or another ICS+LABA+LAMA FDC according to SPC
- At least 6 months of inhaled therapy with ICS+LABA (high dose) or ICS+LABA+LAMA (medium or high dose) before switching or escalating asthma medication at baseline
Key exclusion criteria (4 listed)
- Use of a digital inhaler-coupled inhalation tracking system to support adherence in the last 3 months prior to study entry
- Simultaneous participation in an interventional study or in another Novartis-sponsored noninterventional study
- Asthma therapy with a biological agent, if not stable at the same dosage for at least 3 months
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 |
|---|---|---|
| MF/IND/GLY plus sensor systemThere is no treatment allocation. Patients administered MF/IND/GLY plus sensor system by prescription that have started before inclusion of the patient into the study will be enrolled. Subjects will receive MF/IND/GLY together with the Propeller add-on sensor for the Breezhaler® according to label. | Combination product | MF/IND/GLY Breezhaler® plus Propeller Health |
| FDC therapyThere is no treatment allocation. Patients administered FDC therapy by prescription that have started before inclusion of the patient into the study will be enrolled. | Drug | Other FDC therapy |
Primary outcome
Change in asthma control test (ACT) score
Time frame: Baseline, week 26
ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. It is a self-administered questionnaire comprising five items that are assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of >=20 denoting 'controlled asthma', a score of 16-19 denoting 'partially controlled asthma', and a score of <=15 denoting 'uncontrolled asthma'. The total score is calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control.
10 secondary outcomes
Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician
Time frame: Baseline
Description of of patient characteristics at baseline
Time frame: Baseline
Percentage of patients showing an improvement in self-reported test adherence to inhalers (TAI) questionnaire
Time frame: 26 weeks
Course of adherence in the subgroup receiving MF/IND/GLY plus sensor
Time frame: 26 weeks
Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor
Time frame: 26 weeks
Percentage of patients achieving the minimal clinically important difference (MCID) change
Time frame: Baseline, week 26
Percentage of patients with an ACT score <19
Time frame: 26 weeks
Change in Post-dose trough Forced Expiratory Volume in one second (FEV1)
Time frame: Baseline, week 26
Change in Forced vital capacity (FVC)
Time frame: Baseline, week 26
Adverse events
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Results for CQVM149BDE01 that is getting linked from the Novartis Clinical Trials WebsiteLink 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
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Novartis Pharmaceuticals at 26 sites in Germany.
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 11 inclusion and 4 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 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 asthma control test (ACT) score (time frame: Baseline, week 26). 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 25 Mar 2024.