NCT03300076

COMPLliancE and qualiTy of lifE in Asthma

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: Elpen Pharmaceutical Co. Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Asthma
• Compliance, Patient
• Quality of Life

Timeline

• Start date: 2018-02-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-10-03
• Last updated: 2018-12-05

Locations

1 site across 1 country: Greece