AsthmaSiASMARTerNCT06908421
Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence
An observational study of Asthma, run by Chiesi Pharma AB, Nordic at 2 sites in Denmark.
Trial summary
The goal of this observational study is to determine if using the SiA® (Systematic Intervention Agent) system can improve inhaler technique and medication adherence in adults with asthma who are already using Trimbow pMDI inhalers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Sep 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthma patients above 18 years of age, with objectively verified diagnosis of asthma according to GINA, uncontrolled T2 inflammation (FeNO >25ppm) on BDP/FF/G inhalation treatment with prescribed rescue medication (SABA).
Who may be able to join
- Patients ≥18 years of age.
- Objectively verified leading diagnosis of asthma according to GINA
- FeNO >25 ppb.
- Treated with Trimbow 87/5/9 pMDI for >4 weeks before enrolment,
- with prescribed rescue medication (SABA).
- with and without prescription of a spacer.
Show all 10Show fewer
- Being literate Danish.
- Having a personal Android/iOS phone and 4G/5G internet connection.
- Comfortable using a smart phone and Bluetooth enabled Digital Devices.
- Willingness to participate in the study, understand the written patient information and being able to provide written informed consent.
Who cannot join
- Participation in a clinical trial within 4 weeks prior to enrolment into the present study or planned enrolment in a clinical trial during the observational period.
- Use of systemic corticosteroid as maintenance treatment.
- Treated with biologics (that is monoclonal antibodies).
- Concomitant diagnosis of COPD.
- Lung cancer or history of lung cancer.
- Respiratory tract infection/exacerbation within 4 weeks prior to enrolment.
- Use of oral corticosteroids within 4 weeks before enrolment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Central Jutland, DK-8200 Aarhus N
Johannes M Schmid, PhD, ass. professor, +4578462106, joschm@rm.dk
Johannes M Schmid, PhD, ass. professor
- Recruiting
Copenhagen University Hospital-Hvidovre
Hvidovre, Capital Region, DK-2650
Charlotte S Ulrik, MD, DMSc, FERS, +4538622177, charlotte.Suppli.Ulrik@regionh.dk
Charlotte S Ulrik, charlotte.Suppli.Ulrik@regionh
About this study
Official title: A 52-week, Multicentre, Observational, Prospective Study on the Use of a Smart Platform Connected to a Single-inhaler Triple Therapy (ICS/LABA/LAMA) to Evaluate Effectiveness on Treatment Adherence and Inhaler Technique in Patients With Poorly Controlled Asthma.
The goal of this observational study is to determine if using the SiA® (Systematic Intervention Agent) system can improve inhaler technique and medication adherence in adults with asthma who are already using Trimbow pMDI inhalers. Furthermore, it will be addressed if the SiA® system can be used to discriminate between patients, where increased inflammatory markers are caused by incorrect inhaler technique/adherence to medication or patients that have ongoing inflammation requiring adjustment of therapy. Potentially those who might become candidate for biological treatments.
The main questions it aims to answer are:
Read more
- Can the SiA® system improve inhaler use and medication adherence in asthma patients?
- Does improving inhaler technique and adherence lead to better asthma control and reduced airway inflammation (measured by FeNO levels)?
Participants will:
- Use the SiA® system, which includes a smart inhaler cap (RespiPRO™) and a mobile app
- Continue their prescribed Trimbow pMDI treatment for asthma.
- Have their asthma control, lung function, and FeNO levels monitored at specific points over 1 year (3 months and 12 months).
The study does not have a comparison group and all results will be compared to baseline.
Read the detailed description
Background and Rationale Asthma is a chronic inflammatory disease of the airways that affects millions of individuals worldwide. Despite the availability of effective inhaled medications, poor adherence and incorrect inhaler technique remain major barriers to optimal asthma control. Studies show that up to 86.7% of asthma patients make at least one inhaler technique error, and 30-40% demonstrate poor adherence to their prescribed medication. These factors contribute to worsened symptoms, increased healthcare utilization, and reduced quality of life.
The SiA® system, developed by Briota ApS, aims to address these challenges by integrating a smart inhaler cap (RespiPRO™) with a mobile application. This system provides real-time feedback on inhaler technique and adherence, allowing patients and healthcare providers to track progress and make necessary adjustments.
This study seeks to determine whether using the SiA® system alongside a pressurized metered dose inhaler (pMDI) therapy can lead to measurable improvements in medication adherence, inhalation technique, and asthma control. Furthermore, it will be addressed if the SiA® system can be used to discriminate between patients, where increased inflammatory markers are caused by inadequate treatment caused by incorrect inhaler technique/adherence to medication or patients that have ongoing inflammation requiring adjustment of therapy. Potentially those who might become candidate for biological treatments.
Study Design This is a prospective, single-arm observational study conducted at two hospitals in Denmark. It is designed to assess how the SiA® System impacts inhaler technique and medication adherence over a 12-month period.
Key Features of the Study Design:
- Observational (non-interventional): Participants will continue their standard asthma medication (Trimbow pMDI) but will use the SiA® system to monitor their inhaler technique and adherence.
- Single-arm design: All participants will receive the SiA® System - there is no comparison group.
- Real-world setting: The study aims to reflect how patients interact with the SiA® system in everyday life, outside of a controlled clinical trial environment.
Study Setting:
- Conducted at two specialized respiratory clinics in Denmark.
- Participants will be recruited from routine asthma care visits.
Data Collection Methods:
Data will be collected through multiple sources:
- Hospital medical records (to gather historical asthma data and prior exacerbation history).
- Spirometry tests (to assess lung function).
- FeNO tests (to measure airway inflammation).
- SiA® System data (to track inhaler adherence and technique).
- Patient-reported outcome measures (questionnaires on asthma symptoms and quality of life).
Technology Used in the Study:
- RespiPRO™ Smart Inhaler Cap: A device that attaches to Trimbow pMDI and records inhaler usage data.
- SiA® Mobile App: Tracks daily inhaler use, provides feedback, and sends adherence reminders.
Study Timeline:
Total Study Duration: 22 months, with individual patient follow-up lasting 12 months (52 weeks).
Patient Flow and Study Visits:
- Screening and Baseline Visit (Week 0) - Study Enrolment
- Patients will be identified during routine asthma care visits and screened for eligibility.
- Informed consent will be obtained.
- Baseline data collection will include:
- Medical history
- Asthma severity and medication use
- Spirometry test (lung function)
- FeNO test (airway inflammation)
- ACT (Asthma Control Test) and mini-AQLQ (Asthma Quality of Life Questionnaire)
- Patients will receive a brief training session on how to use the SiA® System.
- A baseline inhaler technique video will be recorded using the SiA® Mobile App.
- Interim Follow-up Visit (Week 12) - Progress Check
- Patients will return for an in-person visit.
- Repeat measurements:
- FeNO test (to check inflammation levels).
- Spirometry (lung function test).
- ACT and mini-AQLQ (patient-reported outcomes).
- Adherence data from the SiA® system will be reviewed.
- Patients will complete a satisfaction survey about their experience with the SiA® system.
- Final Study Visit (Week 52) - End of Study
- Repeat FeNO, spirometry, ACT, and mini-AQLQ assessments.
- The final inhaler technique video will be recorded and analyzed.
- Patients will return or deactivate the RespiPRO™ Smart Inhaler Cap.
- Final adherence and inhalation technique data will be collected from the SiA® Dashboard.
Potential Impact of the Study
This study aims to generate real-world evidence on how digital health interventions can improve asthma management. If successful, the SiA® System could:
- Enhance asthma control by ensuring patients use their inhalers correctly.
- Reduce unnecessary medication escalation, preventing overuse of corticosteroids.
- Lower healthcare costs by reducing asthma-related hospital visits.
- Empower patients with real-time feedback and better self-management tools.
- Improve and optimize the way asthma patients become candidate for biological treatments
- Conditions
- Asthma
- Keywords
- Asthma, Inhaler treatment, smart add-on device, adherence, inhaler technique
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Asthma patients above 18 years of age, with objectively verified diagnosis of asthma according to GINA, uncontrolled T2 inflammation (FeNO >25ppm) on BDP/FF/G inhalation treatment with prescribed rescue medication (SABA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of the SiA® platform on the level of the type 2 inflammation biomarker FeNO
To assess the impact of the study on the type 2 biomarker FeNO with a change from baseline of at least 20% will be considered clinically relevant. FeNO values will be presented as ppb. FeNO levels of < 25 ppb, 25 - 50 ppb, > 50 ppb, are considered low, medium, and high respectively.
Measured: Change from baseline in FeNO at week 12 and 52.
Secondary outcomes (8)
To assess the impact of the SiA® platform on adherence to SITT and inhaler technique measure using the RespiPRO add-on module
Change in inhaler adherence measured as percentage of days covered and inhaler technique scores based an assessments of inhalation video recordings an data collected from the SiA® platform using a scoring system of 1-5, where 5 = Optimal technique; 4 = Poor technique with one critical error; 3 = Poor technique with two critical errors; ≤2 = Poor technique with three or more critical errors. The RespiPRO™ cannot monitor step 1 and 2, thus are these by default set to 1, hence the minimum inhaler technique scores achievable from RespiPRO™ is 2.
Measured: Change in pMDI inhaler technique score and medication adherence score at week 12 and 52 compared to baseline.
To evaluate the impact of the SiA® platform on asthma control using Asthma Control Test
Asthma control will be assesed using Asthma Control Test (ACT), which is a patient self-administred tool for identifying those with poorly controlled asthma. A maximum score of 25 points indicates complete asthma control. A score between 20 and 25 represents well controlled asthma, while a score of 19 or below represents not well controlled asthma, and a score less than 16 indicates very poorly controlled asthma.
Measured: Change in ACT scores from baseline at weeks 12 and 52
To evaluate the impact of the SiA® platform on health-related quality of life
To assess the impact of the study on Health-related Quality of Life (HR QoL) using Asthma Quality of Life Questionnaire (mini-AQLQ). The mini-AQLQ has 15 questions in the same domains as the original AQLQ (symptoms, activities, emotions and environment).
Measured: Change in mini-AQLQ scores from baseline at weeks 12 and 52
To evaluate the impact of the SiA® platform on lung function measured by spirometry
Change in lung function parameters (change in mean FEV1, FEV1 %-predicted, FEV1/FVC ratio, FEF25-75) from baseline at weeks 12 and 52
Measured: From baseline and at week 12 and 52.
To evaluate the impact of the SiA® platform on shifts in FeNO category
Change in FeNO category (low, intermediate, high) defined as (< 25 ppb, 25 - 50 ppb, > 50 ppb, respectively.
Measured: Change from baseline at week 12 and 52.
To evaluate the impact of the SiA® platform on annualized exacerbations rates
Retrospective data from the past 12 months will gathered the number of moderate and severe exacerbations as defined by the American Thoracic Society/European Respiratory Society.
Measured: Change in annualized exacerbation rates (moderate and severe) from baseline at week 52
o evaluate the impact of the SiA® platform on the use of rescue medication (SABA)
To assess the impact of the study intervention on use of rescue medication (SABA) measured as average puffs per day/week/month.
Measured: Change from baseline (first 7 days after entering the study) in the use of rescue medication (SABA) at week 12 and 52).
Satisfaction and compliance with add-on device based on a customized survey
Satisfaction score at week 52 assessed using a customized questionnaire. The survey reports on 9 question related to the satisfaction with SiA® platform. Each of the 9 question can be given a score from 1-5. where 1 = very difficult/dissatisfied, 3 = neutral, and 5 = very easy/satisfied.
Measured: at week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start15 Sep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Pharma AB, Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Briota ApS
- Responsible party
- Sponsor
- Investigators
- Johannes M Schmid, PhD, ass. professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908421
- Sponsor's protocol ID
- 1-10-72-193-23
- Acronym
- SiASMARTer
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baekdal JA, Krogh N, Sakhare G, Bendstrup E, Ulrik CS, Schmid JM. Study protocol: a 52-week, multicentre, observational, prospective study on the use of a smart platform connected to a single-inhaler triple therapy (ICS/LABA/LAMA) to evaluate effectiveness on treatment adherence and inhaler technique in patients with poorly controlled asthma. BMC Pulm Med. 2026 Jul 7. doi: 10.1186/s12890-026-04454-1. Online ahead of print.
PubMed 42414967
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week, Multicentre, Observational, Prospective Study on the Use of a Smart Platform Connected to a Single-inhaler Triple Therapy (ICS/LABA/LAMA) to Evaluate Effectiveness on Treatment Adherence and Inhaler Technique in Patients With Poorly Controlled Asthma.
- ClinicalTrials.gov ID
- NCT06908421
- Acronym / sponsor ID
- SiASMARTer / 1-10-72-193-23
- Conditions
- Asthma
- Keywords
- Asthma, Inhaler treatment, smart add-on device, adherence, inhaler technique
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chiesi Pharma AB, NordicIndustry (pharma, biotech, devices)
- Collaborators
- Briota ApS
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Apr 2025 (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 goal of this observational study is to determine if using the SiA® (Systematic Intervention Agent) system can improve inhaler technique and medication adherence in adults with asthma who are already using Trimbow pMDI inhalers. Furthermore, it will be addressed if the SiA® system can be used to discriminate between patients, where increased inflammatory markers are caused by incorrect inhaler technique/adherence to medication or patients that have ongoing inflammation requiring adjustment of therapy. Potentially those who might become candidate for biological treatments.
The main questions it aims to answer are:
- Can the SiA® system improve inhaler use and medication adherence in asthma patients?
- Does improving inhaler technique and adherence lead to better asthma control and reduced airway inflammation (measured by FeNO levels)?
Participants will:
- Use the SiA® system, which includes a smart inhaler cap (RespiPRO™) and a mobile app
- Continue their prescribed Trimbow pMDI treatment for asthma.
- Have their asthma control, lung function, and FeNO levels monitored at specific points over 1 year (3 months and 12 months).
The study does not have a comparison group and all results will be compared to baseline.
Detailed description
Background and Rationale Asthma is a chronic inflammatory disease of the airways that affects millions of individuals worldwide. Despite the availability of effective inhaled medications, poor adherence and incorrect inhaler technique remain major barriers to optimal asthma control. Studies show that up to 86.7% of asthma patients make at least one inhaler technique error, and 30-40% demonstrate poor adherence to their prescribed medication. These factors contribute to worsened symptoms, increased healthcare utilization, and reduced quality of life.
The SiA® system, developed by Briota ApS, aims to address these challenges by integrating a smart inhaler cap (RespiPRO™) with a mobile application. This system provides real-time feedback on inhaler technique and adherence, allowing patients and healthcare providers to track progress and make necessary adjustments.
This study seeks to determine whether using the SiA® system alongside a pressurized metered dose inhaler (pMDI) therapy can lead to measurable improvements in medication adherence, inhalation technique, and asthma control. Furthermore, it will be addressed if the SiA® system can be used to discriminate between patients, where increased inflammatory markers are caused by inadequate treatment caused by incorrect inhaler technique/adherence to medication or patients that have ongoing inflammation requiring adjustment of therapy. Potentially those who might become candidate for biological treatments.
Study Design This is a prospective, single-arm observational study conducted at two hospitals in Denmark. It is designed to assess how the SiA® System impacts inhaler technique and medication adherence over a 12-month period.
Key Features of the Study Design:
- Observational (non-interventional): Participants will continue their standard asthma medication (Trimbow pMDI) but will use the SiA® system to monitor their inhaler technique and adherence.
- Single-arm design: All participants will receive the SiA® System - there is no comparison group.
- Real-world setting: The study aims to reflect how patients interact with the SiA® system in everyday life, outside of a controlled clinical trial environment.
Study Setting:
- Conducted at two specialized respiratory clinics in Denmark.
- Participants will be recruited from routine asthma care visits.
Data Collection Methods:
Data will be collected through multiple sources:
- Hospital medical records (to gather historical asthma data and prior exacerbation history).
- Spirometry tests (to assess lung function).
- FeNO tests (to measure airway inflammation).
- SiA® System data (to track inhaler adherence and technique).
- Patient-reported outcome measures (questionnaires on asthma symptoms and quality of life).
Technology Used in the Study:
- RespiPRO™ Smart Inhaler Cap: A device that attaches to Trimbow pMDI and records inhaler usage data.
- SiA® Mobile App: Tracks daily inhaler use, provides feedback, and sends adherence reminders.
Study Timeline:
Total Study Duration: 22 months, with individual patient follow-up lasting 12 months (52 weeks).
Patient Flow and Study Visits:
- Screening and Baseline Visit (Week 0) - Study Enrolment
- Patients will be identified during routine asthma care visits and screened for eligibility.
- Informed consent will be obtained.
- Baseline data collection will include:
- Medical history
- Asthma severity and medication use
- Spirometry test (lung function)
- FeNO test (airway inflammation)
- ACT (Asthma Control Test) and mini-AQLQ (Asthma Quality of Life Questionnaire)
- Patients will receive a brief training session on how to use the SiA® System.
- A baseline inhaler technique video will be recorded using the SiA® Mobile App.
- Interim Follow-up Visit (Week 12) - Progress Check
- Patients will return for an in-person visit.
- Repeat measurements:
- FeNO test (to check inflammation levels).
- Spirometry (lung function test).
- ACT and mini-AQLQ (patient-reported outcomes).
- Adherence data from the SiA® system will be reviewed.
- Patients will complete a satisfaction survey about their experience with the SiA® system.
- Final Study Visit (Week 52) - End of Study
- Repeat FeNO, spirometry, ACT, and mini-AQLQ assessments.
- The final inhaler technique video will be recorded and analyzed.
- Patients will return or deactivate the RespiPRO™ Smart Inhaler Cap.
- Final adherence and inhalation technique data will be collected from the SiA® Dashboard.
Potential Impact of the Study
This study aims to generate real-world evidence on how digital health interventions can improve asthma management. If successful, the SiA® System could:
- Enhance asthma control by ensuring patients use their inhalers correctly.
- Reduce unnecessary medication escalation, preventing overuse of corticosteroids.
- Lower healthcare costs by reducing asthma-related hospital visits.
- Empower patients with real-time feedback and better self-management tools.
- Improve and optimize the way asthma patients become candidate for biological treatments
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –Asthma patients above 18 years of age, with objectively verified diagnosis of asthma according to GINA, uncontrolled T2 inflammation (FeNO >25ppm) on BDP/FF/G inhalation treatment with prescribed rescue medication (SABA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma patients above 18 years of age, with objectively verified diagnosis of asthma according to GINA, uncontrolled T2 inflammation (FeNO >25ppm) on BDP/FF/G inhalation treatment with prescribed rescue medication (SABA).
Key inclusion criteria (10 listed)
- Patients ≥18 years of age.
- Objectively verified leading diagnosis of asthma according to GINA
- FeNO >25 ppb.
- Treated with Trimbow 87/5/9 pMDI for >4 weeks before enrolment,
- Being literate Danish.
Key exclusion criteria (7 listed)
- Participation in a clinical trial within 4 weeks prior to enrolment into the present study or planned enrolment in a clinical trial during the observational period.
- Use of systemic corticosteroid as maintenance treatment.
- Treated with biologics (that is monoclonal antibodies).
- Concomitant diagnosis of COPD.
- Lung cancer or history of lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the impact of the SiA® platform on the level of the type 2 inflammation biomarker FeNO
Time frame: Change from baseline in FeNO at week 12 and 52.
To assess the impact of the study on the type 2 biomarker FeNO with a change from baseline of at least 20% will be considered clinically relevant. FeNO values will be presented as ppb. FeNO levels of < 25 ppb, 25 - 50 ppb, > 50 ppb, are considered low, medium, and high respectively.
8 secondary outcomes
To assess the impact of the SiA® platform on adherence to SITT and inhaler technique measure using the RespiPRO add-on module
Time frame: Change in pMDI inhaler technique score and medication adherence score at week 12 and 52 compared to baseline.
To evaluate the impact of the SiA® platform on asthma control using Asthma Control Test
Time frame: Change in ACT scores from baseline at weeks 12 and 52
To evaluate the impact of the SiA® platform on health-related quality of life
Time frame: Change in mini-AQLQ scores from baseline at weeks 12 and 52
To evaluate the impact of the SiA® platform on lung function measured by spirometry
Time frame: From baseline and at week 12 and 52.
To evaluate the impact of the SiA® platform on shifts in FeNO category
Time frame: Change from baseline at week 12 and 52.
To evaluate the impact of the SiA® platform on annualized exacerbations rates
Time frame: Change in annualized exacerbation rates (moderate and severe) from baseline at week 52
o evaluate the impact of the SiA® platform on the use of rescue medication (SABA)
Time frame: Change from baseline (first 7 days after entering the study) in the use of rescue medication (SABA) at week 12 and 52).
Satisfaction and compliance with add-on device based on a customized survey
Time frame: at week 52.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 42414967Baekdal JA, Krogh N, Sakhare G, Bendstrup E, Ulrik CS, Schmid JM. Study protocol: a 52-week, multicentre, observational, prospective study on the use of a smart platform connected to a single-inhaler triple therapy (ICS/LABA/LAMA) to evaluate effectiveness on treatment adherence and inhaler technique in patients with poorly controlled asthma. BMC Pulm Med. 2026 Jul 7. doi: 10.1186/s12890-026-04454-1. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Johannes M Schmid, PhD, ass. professor principal investigator
Aarhus University Hospital
2 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 Chiesi Pharma AB, Nordic at 2 sites in Denmark.
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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolai Krogh, PhD (+4526850170, n.krogh@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of the SiA® platform on the level of the type 2 inflammation biomarker FeNO (time frame: Change from baseline in FeNO at week 12 and 52.). 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 NCT06908421, 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 5 Sep 2025.