EW VALUE study

Not Applicable

Completed

• Conditions: COPD including Asthma COPD Overlap (ACO)

• Registration Number: JPRN-jRCT1080224832
• Lead Sponsor: GSK K.K.

Brief Summary

This study is the first study in which evaluated the usefulness and acceptance of telemonitoring for Japanese patients with COPD for a year. The actual use of telemedicine, the satisfaction and acceptance were collected, evaluated, and shown positive responses not only by patients but also by healthcare providers.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-16
• Study Completion: 2021-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1.Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
2.Participant must be more than 40 years of age inclusive at the time of signing the ICF.
3.An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society and JRS COPD and ACO guidelines.
4.Participant must be treated with inhaled LAMA and/or LABA as maintenance medication at the screening visit. LAMA/ LABA or ICS combinations will be allowed but inhaled triple therapy (e.g. ICS/LAMA/LABA) will not be allowed at baseline visit. Other short acting bronchodilators, roflumilast, systemic steroids, or antibiotics medications are permitted.
5.Participant may be male or female.
6.Patient who is having a lung function test result within last 12 months prior to study.

Exclusion Criteria

1.Patients who are unable or unwilling to use the required telemonitoring device/ system.
2.Patients who are treated with ICS/LAMA/LABA triple combination at screening visit or during past 3 months before screening visit even open or closed combinations.
3.Patients who are treated with biologicals during past 6 months before screening visit such as omalizumab or mepolizumab.
4.Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
5.Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/ product (pharmaceutical product)

Study & Design

• Study Type: Interventional
• Study Design: Not specified