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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.

Tracking Information
First Submitted Date January 13, 2017
First Posted Date January 27, 2017
Last Update Posted Date January 25, 2018
Actual Study Start Date February 2, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2017)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 26, 2017)
  • Spirometry:The change in FEV1 [ Time Frame: 6 months ]
    The change in FEV1
  • Quality of Life [ Time Frame: 6 months ]
    Evaluation of the quality of life of patients by changing the AQLQ questionnaire
  • 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
  • Safety assessed by the incidence and frequency of exacerbations [ Time Frame: 6 months ]
    The incidence and frequency of exacerbations
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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
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.
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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Asthma
  • Quality of Life
Intervention Other: Budesonide/Formoterol treated patients
patients who are eligible to start their treatment with budesonide/formoterol therapy
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 24, 2018)
980
Original Estimated Enrollment
 (submitted: January 26, 2017)
2000
Actual Study Completion Date December 30, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT03033758
Other Study ID Numbers 2016-HAL-EL-69
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Elpen Pharmaceutical Co. Inc.
Study Sponsor Elpen Pharmaceutical Co. Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Elpen Pharmaceutical Co. Inc.
Verification Date April 2017