AdditioN of Fixed Dose Combination (FDC) Of Budesonide/Formoterol Via Elpenhaler® Device in Greek Patients With asThma acc?rding to Standard Clinical Practice.

Summary

Participation Requirements

Description

Pulmoton® is an inhaled combination of budesonide and formoterol fumarate dihydrate in doses of 100 / 6mcg, 200 / 6mcg, 400/12 mcg, administered by Elpenhaler®, a powder inhaler developed in doses developed by the ELPEN. It has been approved as a bronchodilator in the treatment of asthma where combi...

Pulmoton® is an inhaled combination of budesonide and formoterol fumarate dihydrate in doses of 100 / 6mcg, 200 / 6mcg, 400/12 mcg, administered by Elpenhaler®, a powder inhaler developed in doses developed by the ELPEN. It has been approved as a bronchodilator in the treatment of asthma where combination therapy (ICS / LABA) is appropriate in patients who are not adequately controlled with inhaled corticosteroids and rely on short-acting inhaled ?2-stimulants or in patients already satisfactorily controlled with both corticosteroids. long-acting ?2-stimulants. Pulmoton® is not recommended for the initial treatment of asthma. The dosage of the individual components of Pulmoton® is separate and must be adjusted according to the severity of the condition. This should be taken into account, not only when starting treatment with stable combination products, but also when adjusting the maintenance dosage. The dose should be adjusted to the lowest possible, by which effective control of symptoms is achieved and maintained. Patients should be re-evaluated regularly by their physician so that the dose of Pulmoton® they receive remains the best possible. When long-term control of symptoms is achieved with the lowest recommended dose, then in the next step only the inhaled corticosteroid can be tested. There are two alternatives to treating asthma with Pulmoton®: A. Pulmoton® Maintenance Therapy: Pulmoton® is taken as a regular maintenance treatment along with a separate rapid-acting bronchodilator to relieve symptoms. B. Pulmoton® Maintenance and Relief Therapy: Pulmoton® is also taken as regular maintenance and invocative treatment for symptoms. Further information on the efficacy and safety of the drug under study can be found in the Product Characteristics Summary (SmPC). Aims of the study The GINA 2020 guidelines recommend, among other things, the symptom-driven use of ICS / LABA (as needed). This study will record the use of budesonide / formoterol either as maintenance treatment or / or as needed according to standard clinical practice and at the discretion of the treating physician.

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