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. (BOREAS)

Observational Study to Evaluate the Clinical Efficacy and Improved Quality of Life With the Administration of the Fixed Combination of Budesonide Formoterol, in Approximately 2000 Patients With Asthma

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Asthma
• Intervention / Treatment: Other: Budesonide/Formoterol treated patients

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.

• Study Type: Observational
• Enrollment (Actual): 980

Contacts and Locations

Study Locations

• Greece
  • Mesogion Ave. 152
    • Athens, Mesogion Ave. 152, Greece, Athens 11527
      • 7th Pulmonary Dept, Athens Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Male and Female
• 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
• Regular treatment of asthma, wherein the administration of the combination (inhaled corticosteroid and long-action beta2-agonist) is appropriate
• Patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled beta2-agonists short-acting
• Patients who signed Informed Consent Patients eligible to follow the study procedures

Exclusion Criteria:

• Patients who will be treated out of SpC
• Patients without Informed Consent
• Patients not eligible to follow the study procedures

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACQ (change)	Evaluation of asthma control by varying the ACQ questionnaire from the start of treatment with Pulmoton® up over 6 months (± 2 weeks)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 (change)	The change in FEV1	6 months
Quality of Life (change)	Evaluation of the quality of life of patients by changing the AQLQ questionnaire	6 months
FSI-10 (change)	Satisfaction of the patient to treatment with the inhaled combination budesonide formoterol through Elpenhlaler® device in either of the two dosages, after 3 months of treatment via FSI questionnaire 10	3 months
number of Adverse events	The incidence and frequency of exacerbations	6 months
Comorbidities	Recording of comorbidities which may exist and are known and the estimated change in the respective biochemical markers where they exist and are available)	6 months

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.

Publications and helpful links

Helpful Links

• DOI: https://doi.org/10.18332/pne/144485

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: comorbidities
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate
• Other Study ID Numbers: 2016-HAL-EL-69

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No