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

NCT03055793 | Completed

• 1 other identifier: 2017-HAL-EL-70
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Quality of Life; Satisfaction

Outcome Measures

Primary Outcomes (1)

• Efficacy (ACQ score)

  ACQ score

  3 months

Secondary Outcomes (2)

• Quality of Life (AQLQ score)

  3 months

• Patient Satisfaction (FS1 -10 score)

  3 months

Interventions

budesonide formoterol fixed combination OTHER

Asthmatic patients who will be on budesonide formoterol fixed combination treatment administered by Elpenhaler device.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asthmatic patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

7th Pulmonary Dept, Athens Chest Hospital

Athens, Mesogion Ave. 152, Athens 11527, Greece

Location

MeSH Terms

Conditions

Asthma; Personal Satisfaction

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: March 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)