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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)

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.
 
ClinicalTrials.gov Identifier: NCT03033758
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Brief 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.

Condition or disease Intervention/treatment
Asthma Quality of Life Other: Budesonide/Formoterol treated patients

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Study Type : Observational
Actual Enrollment : 980 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma


Intervention Details:
  • Other: Budesonide/Formoterol treated patients
    patients who are eligible to start their treatment with budesonide/formoterol therapy


Primary Outcome Measures :
  1. Efficacy assessed by the evaluation of asthma control by varying the ACQ questionnaire from the start of treatment with Pulmoton® up over 6 months (± 2 weeks) [ Time Frame: 6 months ]
    Evaluation of asthma control by varying the ACQ questionnaire from the start of treatment with Pulmoton® up over 6 months (± 2 weeks)


Secondary Outcome Measures :
  1. Spirometry:The change in FEV1 [ Time Frame: 6 months ]
    The change in FEV1

  2. Quality of Life [ Time Frame: 6 months ]
    Evaluation of the quality of life of patients by changing the AQLQ questionnaire

  3. Patient Satisfaction [ Time Frame: 3 months ]
    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

  4. Safety assessed by the incidence and frequency of exacerbations [ Time Frame: 6 months ]
    The incidence and frequency of exacerbations

  5. Comorbidities [ Time Frame: 6 months ]
    Recording of comorbidities which may exist and are known and the estimated change in the respective biochemical markers where they exist and are available)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03033758


Locations
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Greece
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.
ClinicalTrials.gov Identifier: NCT03033758    
Other Study ID Numbers: 2016-HAL-EL-69
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Elpen Pharmaceutical Co. Inc.:
comorbidities
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
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