AsthmaTEACHNCT06840522
The Importance of Tailored Education And Device Handling for Asthmatic Patients
An observational study of Asthma, run by Chiesi Hungary Ltd. at 6 sites in Hungary.
Trial summary
Significant advancements have been made in asthma medication over the past decades. Highly effective treatments are available for patients; however, both adherence and proper device usage remain below the desired levels, based on our experience and literature data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 250 participants
- Where
- 6 sitesHungary
- Study dates
- 1 Mar 2025to 1 Aug 2026
- 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, treated in routine clinical practice, symptomatic on previous therapy, and switched to Foster 100/6 micrograms in Nexthaler device, irrespective of study inclusion,
Who may be able to join
- Physician-confirmed clinical diagnosis of asthma according to GINA guidelines
- Uncontrolled asthma according to the physician's clinical assessment despite the use of appropriate therapy of Step 2 or 3, according to GINA guidelines
- Patients who are eligible for the use of Foster Nexthaler 100/6 mcg according to the SmPC
- Inhaled asthma therapy was changed independent from the study to Foster Nexthaler 100/6 mcg DPI maximum 1 week prior to OR on the day of study inclusion
- Spirometry was performed as part of routine clinical practice
- Patient able to use their Foster Nexthaler device properly after education on inhaler technique
- Patient provided written, informed consent to study participation
- Patient ≥ 18 years of age
Who cannot join
- Participation in any clinical trial, 30 days prior to inclusion
- Patient is unable to execute a spirometry test
- Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
- Patients with other significant diseases of the respiratory system or other organ systems that may significantly contribute to asthma symptoms (such as severe heart failure, symptomatic anaemia, functional respiratory disorders, malignant diseases etc.) according to the physician's clinical assessment.
- Continuous use of oral corticosteroids (>5 mg prednisolone/day or >4 mg methylprednisolone/day)
- Use of continuous oxygen therapy
- Use of biologics for asthma treatment
- All exclusion criteria listed in Foster Nexthaler 100/6 SmPC
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Hungary6 sites
National Korányi Institute of Pulmonology
Budapest
Ildikó Horváth, Prof.
Lilla Horváth, Dr.
Department of Pulmonology and Allergology, Csornai MArgit Hospital
Csorna
Zoltán Bártfai, Dr.
Zoltán Bártfai, Dr.
Department of Pulmonology, Debrecen University
Debrecen
Ildikó Horváth, Prof.
Krisztina Kukuly, Dr.
Pulmonology Outpatient Clinic of Dunakeszi
Dunakeszi
Katalin Kontz, Dr
Katalin Kontz, Dr.
Department of Pulmonology, University of Szeged
Szeged
Ádám Mihály
Ádám Mihály, Dr.
Calvinist Pulmonology Centre
Törökbálint
Alpár Horváth, Dr.
Alpár Horváth, Dr
About this study
Significant advancements have been made in asthma medication over the past decades. Highly effective treatments are available for patients; however, both adherence and proper device usage remain below the desired levels, based on our experience and literature data. Despite the availability of numerous excellent drug-device combinations, personalized treatment for patients is still not adequately addressed.
In the present study, the aim is to improve patient compliance and educate symptomatic, partially, or uncontrolled asthma patients on the correct use of a specific inhalation device (Nexthaler). Considering the characteristics of the medication, the patient's lung function data, inhalation technique, and drug retention time can help estimate the expected lung deposition of the medication. By refining the inhalation technique under the guidance of the treating physician, it is hypothesized that the expected therapeutic effects of the medication may improve.
Read the detailed description
Eligible Patient Population:
Patients on GINA step 2-4 therapy who are partially or uncontrolled (ACT <25) and are receiving Foster Nexthaler® therapy as per prescribing guidelines, regardless of the study. Patients on GINA step 3 therapy receive a low-dose ICS-formoterol regimen (2x1 inhalations of Foster Nexthaler® 100/6 μg), while those on GINA step 4 receive a medium-dose ICS-formoterol regimen (2x2 inhalations of Foster Nexthaler® 100/6 μg). Whenever possible, Foster Nexthaler® 100/6 μg is used as a reliever medication following the MART principles. If the treating physician opts for salbutamol (Ventolin®, Buventol®) instead, the patient may still be included in the study, provided justification is given, considering the difficulty of training with multiple inhalation devices (pMDI and DPI with different characteristics).
Study Procedures:
Lung function tests will be performed on enrolled patients. The investigating physician will evaluate the recorded spirometry curves, which will be used for computer modeling to assess pulmonary drug deposition. The spirometry curves are also useful for evaluating the patient's condition and monitoring progress.
During the study visits (V1 - enrollment, V2 - 1 month, V3 - 3 months), the following data will be recorded: patient demographics, medical history, treatment details, risk factors, medication adherence (based on prescription refills and patient self-report), and quality of life assessment. Data collection, particularly questionnaire results, will follow the daily routine of the study center.
Study Objective:
The aim is to demonstrate that patient education on using a specific inhalation device (Foster Nexthaler®), optimizing inhalation technique (prolonging breath-hold time), and the resulting increased drug deposition lead to measurable clinical benefits, improved asthma control, and higher ACT scores.
Education on inhaler use and practicing optimal inhalation techniques are expected to improve lung function, maintain adherence, and reduce the need for rescue medication.
- Conditions
- Asthma
- Keywords
- Inhalation treatment, Lung deposition
- 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 |
|---|---|---|
| Asthma patients on GINA steps 3 and 4 receiving Foster Nexthaler treatment | Asthma patients above the age of 18 years. Uncontrolled according to the physician's clinical assessment despite the use of appropriate therapy of Step 2 or 3, according to GINA guidelines. Patients who are eligible for the use of Foster Nexthaler 100/6 mcg according to the SmPC. Inhaled asthma therapy was changed independent from the study to Foster Nexthaler 100/6 mcg DPI maximum 1 week prior to OR on the day of study inclusion. Spirometry was performed as part of routine clinical practice . Patient able to use their Foster Nexthaler device properly after education on inhaler technique. Patient provided written, informed consent to study participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary deposition
Difference of pulmonary deposition between patients performing different lengths of breath hold and it's changes after 3 months of treatment.
Measured: 3 months
Asthma control questionnaire
Change in asthma control questionnaire (ACQ-6) scores after 3 months of treatment between patients performing different lengths of breath hold.
Measured: 3 months
Secondary outcomes (7)
Asthma control
Proportion of patients achieving improvement in asthma control at Visit 3 between patients performing different lengths of breath hold
Measured: 3 months
Lung function
Change in spirometry parameters: Forced expiratory volume in 1 second, Forced vital capacity and their ratio, at Visit 3, compared to the baseline between patients performing different lengths of breath hold
Measured: 3 months
Rescue medication
Change in the need for rescue medications at Visit 3, compared to the baseline between patients performing different lengths of breath hold
Measured: 3 months
Adherence
Changes in treatment adherence based on prescription filled at Visit 3, compared to the baseline between patients performing different lengths of breath hold
Measured: 3 months
Fractional exhaled nitric oxide
Change in fractional exhaled nitric oxide (FeNO) values at Visit 3 (count and percentage of patients with FeNO above 20 ppb) between patients performing different lengths of breath hold
Measured: 3 months
Health related quality of life
To assess changes in quality of life in EQ-5D-5L domains after 3 months of treatment compared to baseline. Scale on a level of five
Measured: 3 months
Adherence self report
To assess changes itest of adherence to inhalers questionnaire (TAI-12) after 3 months of treatment compared to baseline.
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 posted21 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
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.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Hungary Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840522
- Sponsor's protocol ID
- DE-HI/2024/01
- Acronym
- TEACH
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Tailored Education And Device Handling for Asthmatic Patients
- ClinicalTrials.gov ID
- NCT06840522
- Acronym / sponsor ID
- TEACH / DE-HI/2024/01
- Conditions
- Asthma
- Keywords
- Inhalation treatment, Lung deposition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Chiesi Hungary Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 21 Feb 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.
Significant advancements have been made in asthma medication over the past decades. Highly effective treatments are available for patients; however, both adherence and proper device usage remain below the desired levels, based on our experience and literature data. Despite the availability of numerous excellent drug-device combinations, personalized treatment for patients is still not adequately addressed.
In the present study, the aim is to improve patient compliance and educate symptomatic, partially, or uncontrolled asthma patients on the correct use of a specific inhalation device (Nexthaler). Considering the characteristics of the medication, the patient's lung function data, inhalation technique, and drug retention time can help estimate the expected lung deposition of the medication. By refining the inhalation technique under the guidance of the treating physician, it is hypothesized that the expected therapeutic effects of the medication may improve.
Detailed description
Eligible Patient Population:
Patients on GINA step 2-4 therapy who are partially or uncontrolled (ACT <25) and are receiving Foster Nexthaler® therapy as per prescribing guidelines, regardless of the study. Patients on GINA step 3 therapy receive a low-dose ICS-formoterol regimen (2x1 inhalations of Foster Nexthaler® 100/6 μg), while those on GINA step 4 receive a medium-dose ICS-formoterol regimen (2x2 inhalations of Foster Nexthaler® 100/6 μg). Whenever possible, Foster Nexthaler® 100/6 μg is used as a reliever medication following the MART principles. If the treating physician opts for salbutamol (Ventolin®, Buventol®) instead, the patient may still be included in the study, provided justification is given, considering the difficulty of training with multiple inhalation devices (pMDI and DPI with different characteristics).
Study Procedures:
Lung function tests will be performed on enrolled patients. The investigating physician will evaluate the recorded spirometry curves, which will be used for computer modeling to assess pulmonary drug deposition. The spirometry curves are also useful for evaluating the patient's condition and monitoring progress.
During the study visits (V1 - enrollment, V2 - 1 month, V3 - 3 months), the following data will be recorded: patient demographics, medical history, treatment details, risk factors, medication adherence (based on prescription refills and patient self-report), and quality of life assessment. Data collection, particularly questionnaire results, will follow the daily routine of the study center.
Study Objective:
The aim is to demonstrate that patient education on using a specific inhalation device (Foster Nexthaler®), optimizing inhalation technique (prolonging breath-hold time), and the resulting increased drug deposition lead to measurable clinical benefits, improved asthma control, and higher ACT scores.
Education on inhaler use and practicing optimal inhalation techniques are expected to improve lung function, maintain adherence, and reduce the need for rescue medication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma patients on GINA steps 3 and 4 receiving Foster Nexthaler treatment | – | –Asthma patients above the age of 18 years. Uncontrolled according to the physician's clinical assessment despite the use of appropriate therapy of Step 2 or 3, according to GINA guidelines. Patients who are eligible for the use of Foster Nexthaler 100/6 mcg according to the SmPC. Inhaled asthma therapy was changed independent from the study to Foster Nexthaler 100/6 mcg DPI maximum 1 week prior to OR on the day of study inclusion. Spirometry was performed as part of routine clinical practice . Patient able to use their Foster Nexthaler device properly after education on inhaler technique. Patient provided written, informed consent to study participation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma patients, treated in routine clinical practice, symptomatic on previous therapy, and switched to Foster 100/6 micrograms in Nexthaler device, irrespective of study inclusion,
Key inclusion criteria (8 listed)
- Physician-confirmed clinical diagnosis of asthma according to GINA guidelines
- Uncontrolled asthma according to the physician's clinical assessment despite the use of appropriate therapy of Step 2 or 3, according to GINA guidelines
- Patients who are eligible for the use of Foster Nexthaler 100/6 mcg according to the SmPC
- Inhaled asthma therapy was changed independent from the study to Foster Nexthaler 100/6 mcg DPI maximum 1 week prior to OR on the day of study inclusion
- Spirometry was performed as part of routine clinical practice
Key exclusion criteria (8 listed)
- Participation in any clinical trial, 30 days prior to inclusion
- Patient is unable to execute a spirometry test
- Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
- Patients with other significant diseases of the respiratory system or other organ systems that may significantly contribute to asthma symptoms (such as severe heart failure, symptomatic anaemia, functional respiratory disorders, malignant diseases etc.) according to the physician's clinical assessment.
- Continuous use of oral corticosteroids (>5 mg prednisolone/day or >4 mg methylprednisolone/day)
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
Pulmonary deposition
Time frame: 3 months
Difference of pulmonary deposition between patients performing different lengths of breath hold and it's changes after 3 months of treatment.
Asthma control questionnaire
Time frame: 3 months
Change in asthma control questionnaire (ACQ-6) scores after 3 months of treatment between patients performing different lengths of breath hold.
7 secondary outcomes
Asthma control
Time frame: 3 months
Lung function
Time frame: 3 months
Rescue medication
Time frame: 3 months
Adherence
Time frame: 3 months
Fractional exhaled nitric oxide
Time frame: 3 months
Health related quality of life
Time frame: 3 months
Adherence self report
Time frame: 3 months
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 24 Feb 2025.
- 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.
6 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 Hungary Ltd. at 6 sites in Hungary.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Hungary. 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 Balázs Sánta (+36309948432, b.santa@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary deposition (time frame: 3 months). The study lists 2 primary outcomes in all. 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 24 Feb 2025.