COMPLliancE and qualiTy of lifE in Asthma (COMPLETE)

Multicenter, Open-label, Non Interventional, Prospective, Observational Clinical Trial to Assess the Compliance and Quality of Life in Greek Asthmatic Patients

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Asthma; Compliance, Patient

Detailed Description

Dry powder devices, available since 1970, have been developed to make inhalation simpler than pMDIs and relieve the need for co-ordination of spraying and inhalation, which is particularly important for patient groups such as the elderly and children. In addition, dry powder devices do not contain propellant gases potentially hostile to the environment as they are activated by inhalation of the patient and do not cause cold sensation upon inhalation.

Today, the combination of inhaled corticosteroid (ICS) and long-acting β2-inducer with an inhaler is the basic treatment for asthma6.

The addition of long-acting β2-inducer (LABA) to a daily inhaled corticosteroid regimen1:

• Improves the symptoms,
• Reduces nightly asthma symptoms,
• Improves pulmonary function,
• Reduces the use of β2-agonists for rapid action,
• Reduces the number of seizures,
• Does not increase the risk of hospitalizations due to asthma,
• Achieves clinical asthma control in more patients, faster and with less ICS than would be required if ICS were administered alone.

The greater effectiveness of combination therapy has led to the development of stable combination inhalers that both glucocorticosteroids and LABA (eg, fluticasone-salmeterol, budesonide-formoterol stable compounds) are concomitantly conveyed.

Stable combinations are more user-friendly for patients, potentially increasing compliance, and ensure that LABA is always accompanied by glucocorticosteroid1. Of the combinations available, the budesonide-formoterol combination can be used both as maintenance therapy and symptom relief due to the rapid onset of formoterol compared to salmeterol. Both components of the budesonide-formoterol combination when administered are helpful in enhancing protection from severe seizures in patients receiving combination therapy for maintenance and improve the control of asthma at relatively low ICS doses.

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Sotiria Pulmonary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asthmatic adult patients

Description

Inclusion Criteria:

• 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:

  1. Patients receiving ICS inhaled and SABA invoked
  2. Patients receiving inhaled ICS and LABA with separate devices each
  3. Patients receiving periodic and not continuously stable combination of ICS and LABA but not being treated for at least 1 month
  4. Patients who did not receive any treatment and the doctor decides to immediately start the fixed combination of ICS and LABA

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Change in mini AQLQ scale	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Change in MMAS-8 scale	6 months

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.

Publications and helpful links

General Publications

• 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. Erratum In: BMC Pulm Med. 2022 Aug 23;22(1):322.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2017-HAL-EL-74

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No