NCT06840522Not yet recruiting
The Importance of Tailored Education And Device Handling for Asthmatic Patients
Source: ClinicalTrials.gov · Last updated 24 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 18 Feb 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Chiesi Hungary Ltd.
- Diseases
- Asthma
- NCT number
- NCT06840522
What you commit to
- Study type: Observational
- Planned participants: 250
- From 1 Mar 2025 to the primary completion date, 1 Jun 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in any clinical trial, 30 days prior to inclusion
- Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
- Continuous use of oral corticosteroids (\>5 mg prednisolone/day or \>4 mg methylprednisolone/day)
- Use of continuous oxygen therapy
Other illness
- 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.
Other
- Patient is unable to execute a spirometry test
- Use of biologics for asthma treatment
- All exclusion criteria listed in Foster Nexthaler 100/6 SmPC
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Korányi Institute of Pulmonology Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Department of Pulmonology and Allergology, Csornai MArgit Hospital Coordinator of this site? Confirm its status | Csorna | Hungary | Unknown status |
| Department of Pulmonology, Debrecen University Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Pulmonology Outpatient Clinic of Dunakeszi Coordinator of this site? Confirm its status | Dunakeszi | Hungary | Unknown status |
| Department of Pulmonology, University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Unknown status |
| Calvinist Pulmonology Centre Coordinator of this site? Confirm its status | Törökbálint | Hungary | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.