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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary deposition | 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 | Change in asthma control questionnaire (ACQ-6) scores after 3 months of treatment between patients performing different lengths of breath hold. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control | Proportion of patients achieving improvement in asthma control at Visit 3 between patients performing different lengths of breath hold | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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,
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Balázs Sánta | Contact | +36309948432 | b.santa@chiesi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Korányi Institute of Pulmonology | Budapest | Hungary |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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 | 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 | 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 | 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 | 3 months |
| Adherence self report | To assess changes itest of adherence to inhalers questionnaire (TAI-12) after 3 months of treatment compared to baseline. | 3 months |
| Department of Pulmonology and Allergology, Csornai MArgit Hospital | Csorna | Hungary |
|
| Department of Pulmonology, Debrecen University | Debrecen | Hungary |
|
| Pulmonology Outpatient Clinic of Dunakeszi | Dunakeszi | Hungary |
|
| Department of Pulmonology, University of Szeged | Szeged | Hungary |
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| Calvinist Pulmonology Centre | Törökbálint | Hungary |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |