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.

NCT03033758 | Completed DMC

• 1 other identifier: 2016-HAL-EL-69
• Study Type: observational
• Target: 980
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Quality of Life

Keywords

comorbidities

Outcome Measures

Primary Outcomes (1)

• ACQ (change)

  Evaluation of asthma control by varying the ACQ questionnaire from the start of treatment with Pulmoton® up over 6 months (± 2 weeks)

  6 months

Secondary Outcomes (5)

• FEV1 (change)

  6 months

• Quality of Life (change)

  6 months

• FSI-10 (change)

  3 months

• number of Adverse events

  6 months

• Comorbidities

  6 months

Interventions

Budesonide/Formoterol treated patients OTHER

patients who are eligible to start their treatment with budesonide/formoterol therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who will be treated out of SpC
• Patients without Informed Consent
• Patients not eligible to follow the study procedures

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

7th Pulmonary Dept, Athens Chest Hospital

Athens, Mesogion Ave. 152, Athens 11527, Greece

Location

Related Links

• DOI: https://doi.org/10.18332/pne/144485

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 27, 2017
• Study Start: February 2, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)