COMPLliancE and qualiTy of lifE in Asthma

NCT03300076 | Completed

• 1 other identifier: 2017-HAL-EL-74
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, open, non-interventional, prospective, clinical observational study on Conformity to Therapy and Quality of Life in Asthma in patients living in Greece

Conditions

Asthma; Compliance, Patient; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Change in mini AQLQ scale

  6 months

Secondary Outcomes (1)

• Compliance

  6 months

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

Asthmatic adult patients

You may qualify if:

• Male or female asthma patients over 18 years of age
• Compliance with treatment
• Compliance with study procedures
• Signed informed consent form
• Patients not satisfactorily controlled with inhaled corticosteroids and the use of inhaled short-acting β2-primers or patients already adequately controlled with both inhaled corticosteroids and long-acting β2-stimulants:
• Patients receiving ICS inhaled and SABA invoked
• Patients receiving inhaled ICS and LABA with separate devices each
• Patients receiving periodic and not continuously stable combination of ICS and LABA but not being treated for at least 1 month
• Patients who did not receive any treatment and the doctor decides to immediately start the fixed combination of ICS and LABA

You may not qualify if:

• Male or female asthma patients under 18 years of age
• Unsigned patient consent
• Non-compliance with treatment
• Non-compliance in study procedures
• COPD patients (at any stage)

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Sotiria Pulmonary Hospital

Athens, Greece

Location

Related Publications (1)

• Exarchos KP, Rovina N, Krommidas G, Latsios D, Gogali A, Kostikas K. Adherence and quality of life assessment in patients with asthma treatment with budesonide/formoterol via the Elpenhaler device: the COMPLETE study. BMC Pulm Med. 2022 Jun 27;22(1):254. doi: 10.1186/s12890-022-02049-0.

  PMID: 35761234 DERIVED

MeSH Terms

Conditions

Asthma; Patient Compliance

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

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

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: February 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-03

Locations

GR (1)