NCT06840522

The Importance of Tailored Education And Device Handling for Asthmatic Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Chiesi Hungary Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Asthma

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2025-02-21
• Last updated: 2025-02-24

Locations

6 sites across 1 country: Hungary