COPD including Asthma COPD Overlap (ACO)
Conditions
Sponsors
GSK K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| exploratory To assess the feasibility, based on data completeness and frequency of use, of using a telemedicine platform as an effective tool to help investigators and participants with the management of COPD in Japan. Percentage of administrations the daily questionnaire was completed. Percentage of administrations the weekly CAT was completed. Percentage of participants completing the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| exploratory To assess the acceptability of using a telemedicine platform for COPD management based on patient and physician satisfaction. 1. Percentage of participants providing positive answer from participants' questionnaire, section 2.1, 2.2. and 2.4, about the telemedicine platform at the interim and end of study. 2. Percentage of investigators providing positive answer from investigators' questionnaire, section 2.1, 2.2. and 2.4, about the telemedicine platform at the interim and end of study. | — |
Countries
Japan
Outcome results
None listed