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NCT Number: NCT03055793

Quality of Life Assessment in Greek asthmatIc Patients Treated With the Fixed Dose Combination of Budesonide / Formoterol in Clinical Practice

The greater efficacy of combination therapy led to the development of fixed combination devices which simultaneously carry both glucocorticosteroid and a LABA (eg stable combinations of fluticasone-salmeterol, budesonide-formoterol).

Fixed combinations are easier to use for patients, potentially increasing compliance, and ensure that the LABA always accompanied by glycocorticosteroeides1. From the available combinations of the combination of budesonide-formoterol can be used both in maintenance therapy and for the relief of symptoms due to the rapid onset of action of formoterol compared with salmeterol. Both components of budesonide-formoterol combination when administered on demand contribute to strengthening protection from severe exacerbations in patients receiving combination therapy for maintenance, and enable improvement of asthma control at relatively low doses of ICS.

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Key information

Conditions

Asthma Behavior Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Personal Satisfaction Quality of Life Respiratory Hypersensitivity Respiratory Tract Diseases Satisfaction

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

7th Pulmonary Dept, Athens Chest Hospital

Athens, Mesogion Ave. 152, Athens 11527, Greece

About this study

This prospective observational study of the Greek population to approximately 2,500 patients suffering from asthma, aims to collect the characteristics of patients that were selected to obtain an inhaled combination of budesonide and formoterol fumarate dihydrate in any of portions 100 / 6mcg, 200 / 6mcg, 400/12 mcg (Pulmoton®), and to collect data on the quality of life to such an inhaled combination through Elpenhaler® device.

Data will be collected for a period of three 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 long-acting beta2-agonists.

Data will be collected during the period of one (1) to three (3) months (± 2 weeks) from the initiation of treatment with inhaled combination include ACQ checklist questionnaire mini AQLQ, questionnaire FSI 10, and data any existing comorbidities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women patients with asthma over 18 years
  • Compliant to treatment
  • Compliant to the study procedures
  • Signed consent form after written study information
  • Patients with Asthma to start treatment with the inhaled combination of budesonide / formoterol at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg, through Elpenhaler® device may be included in the study. Under current SPC, the drug Pulmoton® indicated in the regular treatment of asthma, wherein the administration of the combination (inhaled corticosteroid and long-action beta2-agonist) is appropriate, namely in patients:
  • patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled beta2-agonists short-acting or
  • already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists Note: Pulmoton® 100/6 micrograms / dose is not suitable for patients with severe asthma.

Exclusion criteria

  • Men or women with Asthma patients under 18 years
  • Non-compliance to treatment
  • Non-compliance to study procedures
  • Do not signed patient consent
  • Incorrect use of inhaled therapies
  • Patients with COPD (any stage)
  • Patients already receiving any combination ICS / LABA at entry into the study

Treatment and study plan

budesonide formoterol fixed combination

Other

Asthmatic patients who will be on budesonide formoterol fixed combination treatment administered by Elpenhaler device.

Primary outcomes

  1. Efficacy (ACQ score)

    Time frame: 3 months

    ACQ score

Secondary outcomes

  1. Quality of Life (AQLQ score)

    Time frame: 3 months

    AQLQ score

  2. Patient Satisfaction (FS1 -10 score)

    Time frame: 3 months

    FS1 -10 score

Sponsors and collaborators

Lead sponsor

Elpen Pharmaceutical Co. Inc.

Industry

Registry information

Official study title

A Real Life, on International, Multicenter Study to Assess the Efficacy and Quality of Life in Greek Asthmatic Patients Who Will be on Fixed Dose Bodesonide Formoterol Combination Treatment

Acronym: SKIRON

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 16, 2017
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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