Clinical trial NCT06840522: The Importance of Tailored Education And Device Handling for Asthmatic Patients
Official title: The Importance of Tailored Education And Device Handling for Asthmatic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Keywords: Inhalation treatment
Lung deposition
Lead sponsor: Chiesi Hungary Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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,

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary deposition
timeFrame: 3 months
measure: Asthma control questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Asthma control
timeFrame: 3 months
measure: Lung function
timeFrame: 3 months
measure: Rescue medication
timeFrame: 3 months
measure: Adherence
timeFrame: 3 months
measure: Fractional exhaled nitric oxide
timeFrame: 3 months
measure: Health related quality of life
timeFrame: 3 months
measure: Adherence self report
timeFrame: 3 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Korányi Institute of Pulmonology
city: Csorna
country: Hungary
facility: Department of Pulmonology and Allergology, Csornai MArgit Hospital
city: Debrecen
country: Hungary
facility: Department of Pulmonology, Debrecen University
city: Dunakeszi
country: Hungary
facility: Pulmonology Outpatient Clinic of Dunakeszi
city: Szeged
country: Hungary
facility: Department of Pulmonology, University of Szeged
city: Törökbálint
country: Hungary
facility: Calvinist Pulmonology Centre
Study officials:
References: