Health TrialsbyHealthPanel

The Importance of Tailored Education And Device Handling for Asthmatic Patients

ConditionAsthma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChiesi Hungary Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Participation in any clinical trial, 30 days prior to inclusion

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.

Trial 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,

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 1 trial group
Group A: Asthma patients on GINA steps 3 and 4 receiving Foster Nexthaler treatment

Trial outcomes

Primary outcomes

1

Pulmonary deposition

Difference of pulmonary deposition between patients performing different lengths of breath hold and it's changes after 3 months of treatment.

Time frame
3 months
2

Asthma control questionnaire

Change in asthma control questionnaire (ACQ-6) scores after 3 months of treatment between patients performing different lengths of breath hold.

Time frame
3 months

Secondary outcomes

1

Asthma control

Proportion of patients achieving improvement in asthma control at Visit 3 between patients performing different lengths of breath hold

Time frame
3 months
2

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

Time frame
3 months
3

Rescue medication

Change in the need for rescue medications at Visit 3, compared to the baseline between patients performing different lengths of breath hold

Time frame
3 months
4

Adherence

Changes in treatment adherence based on prescription filled at Visit 3, compared to the baseline between patients performing different lengths of breath hold

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chiesi Hungary Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: