The Importance of Tailored Education And Device Handling for Asthmatic Patients

NCT06840522 | Not Yet Recruiting

• 1 other identifier: DE-HI/2024/01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 6

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.

Conditions

Asthma

Keywords

Inhalation treatment; Lung deposition

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Asthma control

  3 months

• Lung function

  3 months

• Rescue medication

  3 months

• Adherence

  3 months

• Fractional exhaled nitric oxide

  3 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• 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
• 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

You may not qualify if:

• Patient is unable to execute a spirometry test
• Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
• 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.
• Continuous use of oral corticosteroids (\>5 mg prednisolone/day or \>4 mg methylprednisolone/day)
• Use of continuous oxygen therapy
• Use of biologics for asthma treatment

Sponsors & Collaborators

• Chiesi Hungary Ltd.: lead

Study Sites (6)

National Korányi Institute of Pulmonology

Budapest, Hungary

Location

Department of Pulmonology and Allergology, Csornai MArgit Hospital

Csorna, Hungary

Location

Department of Pulmonology, Debrecen University

Debrecen, Hungary

Location

Pulmonology Outpatient Clinic of Dunakeszi

Dunakeszi, Hungary

Location

Department of Pulmonology, University of Szeged

Szeged, Hungary

Location

Calvinist Pulmonology Centre

Törökbálint, Hungary

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Balázs Sánta

CONTACT

+36309948432; b.santa@chiesi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (6)