The Importance of Tailored Education And Device Handling for Asthmatic Patients (TEACH)

February 21, 2025 updated by: Chiesi Hungary Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hungary
      • Budapest, Hungary
        • National Korányi Institute of Pulmonology
        • Contact:
          • Ildikó Horváth, Prof.
        • Sub-Investigator:
          • Lilla Horváth, Dr.
        • Sub-Investigator:
          • Balázs Juhász, Dr.
        • Principal Investigator:
          • Ildikó Horváth, Prof.
        • Sub-Investigator:
          • Péter Somogyi, Dr.
        • Sub-Investigator:
          • Barbara Tamás, Dr.
        • Sub-Investigator:
          • Kincső Marton, Dr.
      • Csorna, Hungary
        • Department of Pulmonology and Allergology, Csornai MArgit Hospital
        • Principal Investigator:
          • Zoltán Bártfai, Dr.
        • Contact:
          • Zoltán Bártfai, Dr.
      • Debrecen, Hungary
        • Department of Pulmonology, Debrecen University
        • Contact:
          • Ildikó Horváth, Prof.
        • Principal Investigator:
          • Ildikó Horváth, Prof.
        • Sub-Investigator:
          • Krisztina Kukuly, Dr.
        • Sub-Investigator:
          • Tamás Kovács, Dr.
      • Dunakeszi, Hungary
        • Pulmonology Outpatient Clinic of Dunakeszi
        • Principal Investigator:
          • Katalin Kontz, Dr.
        • Contact:
          • Katalin Kontz, Dr
      • Szeged, Hungary
        • Department of Pulmonology, University of Szeged
        • Contact:
          • Ádám Mihály
        • Principal Investigator:
          • Ádám Mihály, Dr.
        • Sub-Investigator:
          • Dániel Vas, Dr.
      • Törökbálint, Hungary
        • Calvinist Pulmonology Centre
        • Contact:
          • Alpár Horváth, Dr.
        • Principal Investigator:
          • Alpár Horváth, Dr
        • Sub-Investigator:
          • Izolda Réti, Dr.
        • Sub-Investigator:
          • Botond Havadtői, Dr.
        • Sub-Investigator:
          • Norbert Ilyés, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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,

Description

Inclusion Criteria:

  1. Physician-confirmed clinical diagnosis of asthma according to GINA guidelines
  2. Uncontrolled asthma according to the physician's clinical assessment despite the use of appropriate therapy of Step 2 or 3, according to GINA guidelines
  3. Patients who are eligible for the use of Foster Nexthaler 100/6 mcg according to the SmPC
  4. 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
  5. Spirometry was performed as part of routine clinical practice
  6. Patient able to use their Foster Nexthaler device properly after education on inhaler technique
  7. Patient provided written, informed consent to study participation
  8. Patient ≥ 18 years of age

Exclusion Criteria:

  1. Participation in any clinical trial, 30 days prior to inclusion
  2. Patient is unable to execute a spirometry test
  3. Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
  4. 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.
  5. Continuous use of oral corticosteroids (>5 mg prednisolone/day or >4 mg methylprednisolone/day)
  6. Use of continuous oxygen therapy
  7. Use of biologics for asthma treatment
  8. All exclusion criteria listed in Foster Nexthaler 100/6 SmPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Asthma control
Time Frame: 3 months
Proportion of patients achieving improvement in asthma control at Visit 3 between patients performing different lengths of breath hold
3 months
Lung function
Time Frame: 3 months
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
3 months
Rescue medication
Time Frame: 3 months
Change in the need for rescue medications at Visit 3, compared to the baseline between patients performing different lengths of breath hold
3 months
Adherence
Time Frame: 3 months
Changes in treatment adherence based on prescription filled at Visit 3, compared to the baseline between patients performing different lengths of breath hold
3 months
Fractional exhaled nitric oxide
Time Frame: 3 months
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
3 months
Health related quality of life
Time Frame: 3 months
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
3 months
Adherence self report
Time Frame: 3 months
To assess changes itest of adherence to inhalers questionnaire (TAI-12) after 3 months of treatment compared to baseline.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chiesi Hungary Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DE-HI/2024/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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