Evaluation of the Effectiveness and Quality of Life With the Administration of the Fixed Combination of Budesonide Formoterol in Greek Patients With Asthma During Routine Clinical Practice.
Condition: Asthma; Quality of Life
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study will be conducted in Greek population. The patients who will be selected for study
      enrollment will receive inhaled combination of budesonide and formoterol fumarate dihydrate
      at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg through Elpenhlaler® device. The study end points
      will be efficacy and safety in patients with asthma.Additional study objectives will be
      quality of life, patient satisfaction, severe exacerbation and comorbidities.
    

Detailed description: 
      Asthma is a heterogeneous disease, usually characterized by chronic inflammation of the
      airways. Characterized by a history of respiratory symptoms such as wheezing, chest heaviness
      and cough symptoms that fluctuate over time, as well as variable airway obstruction.

      Asthma is a common disease worldwide, the rates of which are increasing in children and
      adults. It is estimated that asthma affects 1-18% of the population in different countries.
      In Greece, which is a country with lower rates of asthma, it is estimated that 8.6% of the
      population suffers from the disease.

      The diagnosis of asthma should be based on: Background with characteristic symptoms, signs
      variable airway obstruction, with tests for reversal of bronchial obstruction or other tests.

      Long-term treatment of asthma has the following objectives 1. symptom control: achieve
      adequate control of symptoms and maintain normal activity levels 2. Risk Reduction: minimize
      risk of future exacerbations, permanent airflow obstruction and side effects from medication
      Pulmoton® is an inhaled combination of budesonide and formoterol fumarate dihydrate in
      portions 100 / 6mcg, 200 / 6mcg, 400/12 mcg, administered through Elpenhlaler® device,
      developed by ELPEN. It is approved as a bronchodilator in the treatment of asthma where
      administration of the combination (inhaled corticosteroid and long-beta2-agonist action) is
      appropriate in patients not adequately controlled with inhaled corticosteroids and 'as
      needed' inhaled beta2-agonists short-acting or patients already adequately controlled with
      both inhaled corticosteroids and long-acting beta2-agonists.

      Pulmoton® 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 considered not only at the beginning of therapy with fixed
      combination products, but also when adjusting the maintenance dosage.

      The dose should be adjusted to the lowest possible, to achieve and maintain effective control
      of symptoms. Patients should be regularly reassessed by a doctor, so that the dose of
      Pulmoton® receiving remains optimal. When you achieve long-term control of symptoms with the
      lowest recommended dose, then the next step may be testing single administration of inhaled
      corticosteroid.

      There are two alternatives for the treatment of asthma with Pulmoton®:

      A. Pulmoton® maintenance therapy: Pulmoton® taken as regular maintenance treatment with a
      separate rapid-acting bronchodilator for relief of symptoms.

      B. Pulmoton® maintenance and reliever therapy: Pulmoton® taken as regular maintenance and 'on
      demand' therapy to treat the symptoms.

      A. Pulmoton® maintenance therapy:

      Patients should be advised to always carry with them their fast-acting bronchodilator to use
      when there is a need for relief.

      More information on the effectiveness and safety of the study drug, reported in the Summary
      of Product Characteristics (Summary of Product Characteristics (SmPC)

      This prospective observational study aims to collect data regarding Pulmoton® from everyday
      clinical practice, improve the quality of life of patients and disease progression. The
      centers where the study will be approximately 100, both hospital and private pulmonary
      clinics will be held. Data will be collected for a period of 6 months from patients diagnosed
      with asthma not adequately controlled with inhaled corticosteroids and 'as needed' inhaled
      beta2-agonists short-acting or patients already adequately controlled on both inhaled
      corticosteroids and beta2-long-acting stimulants.

      Data will be collected during the period of three (3) and six (6) months (± 2 weeks) from the
      initiation of treatment with inhaled combination include spirometry data, (FEV1, FVC, FEV /
      FVC), checklist ACQ, AQLQ questionnaire and questionnaire FSI 10, and details of any existing
      comorbidities.
    

Intervention name(s): Budesonide/Formoterol treated patients
Intervention type(s): Other
Intervention description(s): patients who are eligible to start their treatment with budesonide/formoterol therapy
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients about to start treatment with the inhaled combination of budesonide and formoterol
        fumarate dihydrate at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg, through Elpenhlaler device
        may be included in the study. Under current SPC, the Pulmoton indicated in the regular
        treatment of asthma, wherein the administration of the combination (inhaled corticosteroid
        and long-action beta2-agonist) is appropriate :

          -  in patients not adequately controlled with inhaled corticosteroids and 'as needed'
             inhaled beta2-agonists short-acting

          -  in patients already adequately controlled on both inhaled corticosteroids and
             long-acting beta2-agonists.
      
Keywords: comorbidities