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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Asthma; Satisfaction
• Intervention / Treatment: Other: budesonide formoterol fixed combination

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1400

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 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asthmatic patients

Description

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

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
Efficacy (ACQ score)	ACQ score	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (AQLQ score)	AQLQ score	3 months
Patient Satisfaction (FS1 -10 score)	FS1 -10 score	3 months

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 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: 2017-HAL-EL-70

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No