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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03055793
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : September 7, 2017
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment
Asthma Quality of Life Satisfaction 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.

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Study Type : Observational
Actual Enrollment : 1400 participants
Observational Model: Other
Time Perspective: Prospective
Official 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
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Intervention Details:
  • Other: budesonide formoterol fixed combination
    Asthmatic patients who will be on budesonide formoterol fixed combination treatment administered by Elpenhaler device.

Primary Outcome Measures :
  1. Efficacy (ACQ score) [ Time Frame: 3 months ]
    ACQ score

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asthmatic patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03055793

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7th Pulmonary Dept, Athens Chest Hospital
Athens, Mesogion Ave. 152, Greece, Athens 11527
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
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Responsible Party: Elpen Pharmaceutical Co. Inc. Identifier: NCT03055793    
Other Study ID Numbers: 2017-HAL-EL-70
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action