AsthmaPhase 4NCT03788395
The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
A Phase 4 study testing Symbicort Turbohaler plus Turbo+ and Symbicort Turbohaler without Turbo+ in people with Asthma, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Symbicort Turbohaler plus Turbo+ and Symbicort Turbohaler without Turbo+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2019to 23 Jan 2020
- Phase
- Phase 4
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- uncontrolled mild or moderate persistent asthma;
Who cannot join
- acute upper respiratory infections;
- immunological or metabolic systemic disease;
- major malformations of the upper airways;
- active smokers.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146
About this study
The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age.
In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application.
The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.
- Conditions
- Asthma
- Being tested
- Symbicort Turbohaler plus Turbo+, Symbicort Turbohaler without Turbo+
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbicort Turbohaler plus Turbo+Device
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.
Symbicort Turbohaler without Turbo+Drug
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.
| Study group | Role | What they receive |
|---|---|---|
| Symbicort Turbohaler plus Turbo+ | Experimental | 10 asthmatic children Receives: Device: Symbicort Turbohaler plus Turbo+ |
| Symbicort Turbohaler without Turbo+ | Active comparator | 10 asthmatic children Receives: Drug: Symbicort Turbohaler without Turbo+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Rating Scale (MARS)
Change in the MARS score from baseline to the end of treatment
Measured: 3 months
Secondary outcomes (3)
Childhood Asthma Control Test (C-ACT)
Change in the C-ACT score from baseline to the end of treatment
Measured: 3 months
Asthma Control Test (ACT)
Change in the ACT score from baseline to the end of treatment
Measured: 3 months
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Change in the PAQLQ score from baseline to the end of treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start10 Jan 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788395
- Sponsor's protocol ID
- 10/2018
- Status last verified
- Jun 2020
- First submitted
- 21 Dec 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
PubMed 35691614
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
- ClinicalTrials.gov ID
- NCT03788395
- Acronym / sponsor ID
- 10/2018
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 27 Dec 2018 (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.
The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age.
In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application.
The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort Turbohaler plus Turbo+ | Experimental | Device: Symbicort Turbohaler plus Turbo+10 asthmatic children |
| Symbicort Turbohaler without Turbo+ | Active comparator | Drug: Symbicort Turbohaler without Turbo+10 asthmatic children |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- uncontrolled mild or moderate persistent asthma;
Key exclusion criteria (4 listed)
- acute upper respiratory infections;
- immunological or metabolic systemic disease;
- major malformations of the upper airways;
- active smokers.
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 |
|---|---|---|
| Symbicort Turbohaler plus Turbo+Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months. | Device | Symbicort Turbohaler plus Turbo+ |
| Symbicort Turbohaler without Turbo+Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months. | Drug | Symbicort Turbohaler without Turbo+ |
Primary outcome
Medication Adherence Rating Scale (MARS)
Time frame: 3 months
Change in the MARS score from baseline to the end of treatment
3 secondary outcomes
Childhood Asthma Control Test (C-ACT)
Time frame: 3 months
Asthma Control Test (ACT)
Time frame: 3 months
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time frame: 3 months
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 9 Jun 2020.
- Derived from this study: PubMed 35691614Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Symbicort Turbohaler plus Turbo+ and Symbicort Turbohaler without Turbo+ in people with Asthma, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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 1 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Medication Adherence Rating Scale (MARS) (time frame: 3 months). 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 NCT03788395, which also lists 1 linked publication.
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 9 Jun 2020.