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AsthmaSENSENCT05120986

An Observational Prospective Study to Characterize Patients Initiating Enerzair® Breezhaler®, With or Without Sensor, as a Maintenance Treatment for Asthma

An observational study of Asthma, run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an observational, descriptive, open-label, prospective, 6-month study including a group of patients with a first prescription of IND/GLY/MF with sensor and a group with a first prescription of IND/GLY/MF without sensor. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Asthma
What is being tested?
IND/GLY/MF
How many people
0 participants
Where
No sites listed yet
Study dates
15 Feb 2022to 15 May 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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with a first prescription of IND/GLY/MF with sensor and a group of patients with a first prescription of IND/GLY/MF without sensor at a community pharmacy setting.

Who may be able to join

  • Male and female patients aged ≥18 years
  • Self-reported diagnosis of asthma
  • Individual filling a first prescription of IND/GLY/MF with or without sensor in a participating community pharmacy for himself/herself (excluding caregivers).
  • Individual capable and willing to perform the study assessments.

Who cannot join

  • No exclusion criteria.

About this study

Official title: Sensor: ENhancing aSthma carE - An Observational Prospective Study to Characterize Patients Initiating Indacaterol + Glycopyrronium Bromide + Mometasone Furoate (Enerzair® Breezhaler®), With or Without Sensor, as a Maintenance Treatment for Asthma

This is an observational, descriptive, open-label, prospective, 6-month study including a group of patients with a first prescription of IND/GLY/MF with sensor and a group with a first prescription of IND/GLY/MF without sensor.

Read the detailed description

Patients will be invited prospectively and sequentially to participate in the study when attending a participating community pharmacy with a first prescription of IND/GLY/MF with sensor or IND/GLY/MF without sensor. Therefore, the invitation for the patient to participate in the study will occur only after the therapeutic decision has taken place

Conditions
Asthma
Being tested
IND/GLY/MF
Keywords
Asthma, SENSE study, Enerzair, Breezhaler, maintenance treatment
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IND/GLY/MFOther

    Also called Enerzair® Breezhaler®

    Prospective observational cohort study. There is no treatment allocation. Patients will be invited to participate in the study when attending participating community pharmacies with a first prescription of IND/GLY/MF with sensor or IND/GLY/MF without sensor

Study groups in NCT05120986
Study groupRoleWhat they receive
IND/GLY/MF with sensorPatients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate with sensor
Receives: Other: IND/GLY/MF
IND/GLY/MF without sensorPatients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate without sensor
Receives: Other: IND/GLY/MF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline sociodemographic - living status

    Assess if the patient lives alone:

    • Yes
    • No
    • Don't know/ Don't answer

    Measured: Baseline

  2. Baseline sociodemographic - household income

    Patient's household net income level:

    • <665 €
    • [665€ to 1000€[
    • [1000€ to 1200€[
    • [1400€ to 1700€[
    • [1700€ to 2000€[
    • [2000€ to 2700€[
    • ≥2700€
    • Don't know/Don't answer

    Measured: Baseline

  3. Baseline sociodemographic - educational level

    Patient's highest completed educational level:

    • None
    • I - Basic education (4 years)
    • II - Basic education (6 years)
    • III - Basic education (9 years)
    • Upper secondary education or equivalent (12 years)
    • Bachelor/ University Degree
    • Don't know/Don't answer

    Measured: Baseline

  4. Baseline sociodemographic - employment status

    Patient Employment status:

    • Employed. Number of hours per week.
    • Unemployed
    • Student
    • Retired
    • Other. Specify.
    • Don't know/Don't answer

    Measured: Baseline

  5. clinical characteristics - body mass index

    body mass index will be provided

    Measured: Baseline

  6. clinical characteristics - smoking status

    Patient smoking status:

    • Never smoked
    • Ex-smoker
    • Smoker
    • Don't know/Don't answer

    Measured: Baseline

  7. clinical characteristics - comorbidities

    Patient comorbidities:

    • Allergic rhinitis
    • Rhinosinusitis
    • Allergic conjunctivitis
    • Sleep disorders
    • Anxiety
    • Depression
    • Other. Specify

    Measured: Baseline

  8. clinical characteristics - duration of disease

    duration of disease will be provided

    Measured: Baseline

  9. clinical characteristics - age at asthma diagnosis

    Age when asthma was diagnosed:

    • Years
    • Unknown/cannot remember

    Measured: Baseline

  10. clinical characteristics - asthma-related hospitalizations

    Number of hospitalizations:

    • n of hospitalizations
    • Don't know/Don't answer

    Measured: Baseline

  11. clinical characteristics - emergency admissions and non-scheduled visits in the previous 12 months

    Number of appointments:

    • number of scheduled asthma physician's appointments
    • number of unscheduled asthma physician's appointments
    • Don't know/Don't answer

    Measured: Baseline

  12. clinical characteristics - ACT score

    The Asthma Control Test (ACT) contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control)

    Measured: Baseline

  13. clinical characteristics - TAI score

    The TAI questionnaire was developed to measure self-reported adherence to inhaler devices and help clinicians to evaluate non-adherence barriers related to inhaled therapy in adult patients with asthma or chronic obstructive pulmonary disease.

    The interpretation of adherence based on the 10-item TAI, scoring is that an overall score of 50 points highlights good adherence, while a score of between 46 to 49 points denotes intermediate adherence. A total score ≤ 45 points indicates poor adherence

    Measured: Baseline

  14. clinical characteristics - last asthma treatment

    International Nonproprietary Name (INN) of Last asthma medication

    Measured: Baseline

Secondary outcomes (18)

  1. Changes from baseline in self-reported adherence - TAI questionnaire score

    The TAI questionnaire was developed to measure self-reported adherence to inhaler devices and help clinicians to evaluate non-adherence barriers related to inhaled therapy in adult patients with asthma or chronic obstructive pulmonary disease.

    The interpretation of adherence based on the 10-item TAI, scoring is that an overall score of 50 points highlights good adherence, while a score of between 46 to 49 points denotes intermediate adherence. A total score ≤ 45 points indicates poor adherence

    Measured: Baseline, month 3, month 6

  2. Changes from baseline in self-reported adherence - asthma control test (ACT) score

    The Asthma Control Test (ACT) contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control)

    Measured: Baseline, month 3, month 6

  3. Adherence from the app (percentage)

    Adherence over last month to be measured using a scale from 0 to 100

    Measured: Month 3, month 6

  4. Asthma control from the app (category)

    Asthma control over last month:

    • Well controlled
    • Not properly controlled
    • Poorly controlled
    • Unknown

    Measured: Month 3, month 6

  5. Rescue medication from the app

    Rescue medication over last month (n days):

    • N days
    • N days over the night period

    Measured: Month 3, Month 6

  6. Percentage of patients in treatment

    Percentage of patients in treatment will be provided

    Measured: month 3, month 6

  7. Reasons for discontinuation and treatment switch

    Reason for treatment discontinuation:

    • Tolerability
    • Loss of efficacy
    • Price
    • Problems with medication use
    • Following emergency/ hospitalization
    • Condition improved
    • Other. Specify.
    • Don't know/Don't answer

    Measured: month 3, month 6

  8. Change from baseline in number of hospitalizations

    Number of hospitalizations and nights:

    • n of hospitalizations
    • n of nights
    • Don't know/Don't answer

    Measured: Baseline, month 3, month 6

  9. Change from baseline in number of emergency room visits

    Number of emergency room visits:

    • n (visits)
    • Don't know/don't answer

    Measured: Baseline, month 3, month 6

  10. Change from baseline in number of scheduled and non-scheduled medical visits

    Number of appointments:

    • n of scheduled appointments
    • n of unscheduled appointments
    • Don't know/ Don't answer

    Measured: Baseline, month 3, month 6

  11. Change from baseline in number of work hours/days missed

    How many hours/days the patient missed work or was delayed:

    • n (days)
    • Not applicable

    Measured: Baseline, month 3, month 5

  12. Percentage of patients by level of treatment satisfaction

    Treatment satisfaction:

    Very satisfied

    • Satisfied
    • Not Satisfied/unsatisfied
    • Unsatisfied
    • Very Unsatisfied

    Measured: month 3, month 6

  13. Percentage of patients who downloaded the app in the group of IND/GLY/MF with sensor.

    Patient downloaded the app:

    • Yes
    • No

    Measured: month 3, month 6

  14. percentage of patients with a valid app report in the group of IND/GLY/MF with sensor.

    Number of patients that downloaded the app

    Measured: month 3, month 6

  15. percentage of patients reporting ease to use and understand how to use the sensor and the app in the group of IND/GLY/MF with sensor

    Ease to use the app/sensor:

    • Yes
    • No
    • Don't know/Don't answer

    Measured: month 3, month 6

  16. percentage of patients reporting usefulness of the sensor/app reports in asthma control and treatmen in the group of IND/GLY/MF with sensor.t

    Usefulness of the app report in learning about their asthma:

    • Yes
    • No
    • Don't know/Don't answer

    Measured: month 3, month 6

  17. Percentage of patients with desire to continue using sensor/app in the group of IND/GLY/MF with sensor.

    Desire to continue using the app:

    • Yes
    • No
    • Don't know/Don't answer

    Measured: month 3, month 6

  18. Percentage of patients with fair acquisition value for sensor/app in the group of IND/GLY/MF with sensor

    Fair acquisition value of sensor/app:

    • 0 €
    • 1 to 5 €
    • 6 to 10€
    • 11 to 15 €
    • 16 to 20 €
    • More than 20 €

    Measured: month 3, month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2021
  2. Study start15 Feb 2022 (estimated)
  3. Primary completion15 May 2023 (estimated)
  4. Study completion15 May 2023 (estimated)

Why it stopped: Novartis Farma - Produtos Farmaceuticos S.A. no longer commercializes the product.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05120986
Sponsor's protocol ID
CQVM149BPT01
Acronym
SENSE
Status last verified
Mar 2022
First submitted
3 Nov 2021
Last updated
4 Apr 2022
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Novartis Pharmaceuticals.

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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Baseline sociodemographic - living status (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05120986.

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 4 Apr 2022.

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