This clinical trial is focused on studying asthma, a condition that affects the airways in the lungs, making it difficult to breathe. The study will evaluate the effectiveness and safety of a new treatment called TEV-56248, which is a combination of two medications: fluticasone propionate and salbutamol sulfate. These medications are delivered as an inhalation powder using a device known as the ICS/SABA Digihaler. The study will also compare this new treatment to another medication called ProAir® RespiClick®, which contains salbutamol sulfate alone.
The purpose of the study is to see if the combination of fluticasone propionate and salbutamol sulfate can reduce severe asthma attacks when used as a rescue medication. Participants in the study will be randomly assigned to receive either the new combination treatment or the existing medication. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will last for a period of 35 days, during which participants will use the inhaler as needed to manage their asthma symptoms.
Throughout the study, researchers will monitor participants to see how long it takes for a severe asthma attack to occur and will also assess the overall control of asthma symptoms. The study aims to provide valuable information on whether the new combination treatment can offer better protection against severe asthma attacks compared to the existing medication. Participants’ safety will be closely monitored, and any side effects will be recorded to ensure the treatment is safe for use.
1joining the study
Upon joining the study, the patient must provide signed informed consent if they are 18 years or older. For patients aged 4 to under 18, assent is required along with written consent from a parent or legally acceptable representative.
2initial assessment
The patient undergoes an initial assessment to confirm a diagnosis of asthma for at least one year. The assessment includes checking the Asthma Control Questionnaire-5 (ACQ-5) score and reviewing the patient’s history of severe asthma exacerbations within the past 12 months.
3medication and dosage
The patient receives a high dose (HD) or low dose (LD) of fluticasone propionate and albuterol sulfate using an integrated electronic module multidose dry powder inhaler (eMDPI). This is compared to using albuterol sulfate eMDPI alone as a rescue medication.
4treatment period
The treatment period involves regular use of the assigned inhaler. The patient is monitored for any severe clinical asthma exacerbations, which are defined as a worsening of asthma symptoms.
5follow-up assessments
Throughout the study, the patient completes follow-up assessments, including the Asthma Control Questionnaire-5 (ACQ-5) and the Asthma Quality of Life Questionnaire + 12 (AQLQ+12) at week 24. These assessments help evaluate the effectiveness of the treatment.
6monitoring for adverse events
The patient is monitored for any adverse events or serious adverse events during the study. If any treatment-emergent adverse events occur, they may lead to withdrawal from the study.
7completion of the study
The study is estimated to end by December 31, 2026. Upon completion, the patient’s data will be analyzed to determine the efficacy and safety of the treatment.
Who Can Join the Study?
The patient must be able to give signed informed consent if they are 18 years or older. For patients aged 4 to under 18 years, they must provide assent, and a parent or legally acceptable representative must give written consent.
The patient must be a male or female who is 4 years of age or older at the time of giving informed consent or assent.
The patient must have been diagnosed with asthma for at least 1 year, following the 2022 GINA guidelines. Asthma is a condition that affects the airways in the lungs, making it hard to breathe.
The patient must have an ACQ-5 score of 1.5 or higher. This score measures asthma control, but patients aged 4-5 years do not need to meet this requirement.
The patient must have a documented history of at least 1 severe clinical asthma exacerbation (CAE) in the past 12 months before screening. A CAE is a worsening of asthma symptoms that may require additional treatment.
The patient must be using any prescribed inhaled asthma controller medication at a stable dose for 1 month before the screening visit. These medications help manage asthma symptoms.
The patient must have a prebronchodilator FEV1 of 40% to less than 90% of the predicted normal value for patients 12 years and older, and 60% to less than 100% for patients aged 4 through 11 years. FEV1 is a test that measures how much air a person can forcefully exhale in one second, and it helps assess lung function. This test is done after withholding certain medications, including SABA (a type of rescue medication), for spirometry testing.
Who Cannot Join the Study?
Patients who have a history of severe allergic reactions to any of the study medications cannot participate.
Individuals who are currently using other medications that might interfere with the study drugs are excluded.
Patients with other significant lung diseases, besides asthma, are not eligible.
Participants who have had a recent respiratory infection, such as a cold or flu, may be excluded.
Individuals who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial within the last 30 days are not allowed to join.
Anyone with a history of drug or alcohol abuse may be excluded from the study.
Patients with certain heart conditions that could be affected by the study medications are not eligible.
Individuals who are unable to use the inhaler device properly are excluded.
Children under the age of 4 are not eligible to participate in the study.
Pneumologie Schlafmedizin und Onkologie am Diako Elke Dankelmann Bernhard Faderl Sabina Wehgartner-Winkler Michael Heller und Prof. Dr. med. Guenter Schlimok Partnerschaft
Augsburg
Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Essen
Germany
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Vratsa
Bulgaria
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Padua
Italy
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Greece
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Fluticasone Propionate/Albuterol Sulfate Fixed-Dose Combination is a medication used in this study to help manage asthma symptoms. It combines two active ingredients: fluticasone propionate, which is a steroid that reduces inflammation in the airways, and albuterol sulfate, which is a bronchodilator that helps open up the airways to make breathing easier. This combination is delivered through a special inhaler designed to be used when asthma symptoms suddenly worsen.
Albuterol Sulfate is another medication used in the study as a comparison. It is a bronchodilator that helps relax muscles in the airways and increase airflow to the lungs. This medication is also delivered through an inhaler and is used to quickly relieve asthma symptoms.
Asthma – Asthma is a chronic condition that affects the airways in the lungs, causing them to become inflamed and narrow. This leads to symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The severity of asthma can vary from person to person, and symptoms may worsen during physical activity or at night. Asthma can be triggered by various factors, including allergens, respiratory infections, cold air, and stress. Over time, repeated asthma attacks can lead to changes in the airways, making them more sensitive and reactive. Managing asthma involves avoiding triggers and monitoring symptoms to prevent exacerbations.
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