Accurate Recognition of Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Airway Obstruction

Treatments: Other: Focus group interview; Other: Candidate item set; Other: Draft item set

Study type: Observational

Funder types: Industry

Identifiers

NCT03170999

201098

Details and patient eligibility

About

It has been observed that COPD exacerbations are under-reported in China. One of the reasons for this is Chinese subjects with COPD cannot describe the symptoms of exacerbation mentioned in English. Hence this study aims to create a tool called CERT that will help Chinese physicians and subjects with COPD to recognize and report exacerbations. The study will be carried out in 4 stages: item identification, cognitive briefing, item reduction and creation of final CERTs. Two CERTs will be prepared, one for subjects with COPD and another for physicians. A total of approximately 200 subjects will be included in the study and each subject will contribute to only one step.

Enrollment: 199 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female of age greater than or equal to 40 years.
• Spirometrically confirmed COPD according to diagnostic criteria in Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016.
• A treated exacerbation of COPD within 3 months prior to the study visit.
• Willing and able to provide informed consent, and able to participate in focus groups or cognitive interviews.
• Literacy is not a requirement for any of the groups.

Exclusion criteria

• Current diagnosis of asthma or clinically relevant bronchiectasis. Note: Subjects with Asthma COPD Overlap Syndrome (ACOS) are eligible.
• Subjects with a concurrent significant, uncontrolled, active medical condition or disease state of other organ diseases or systematic diseases; psychiatric condition; cognitive impairment or any other reasons that in the investigator's opinion, would place subjects at risk or interfere with study evaluation or affect participation in the study.

Trial design

199 participants in 3 patient groups

Subjects included in Focus groups

Description:

Approximately 45 subjects with COPD will participate in the focus group interviews for item identification. The group may contain subjects who are functionally illiterate and at least one third women will be recruited.

Treatment:

Other: Focus group interview

Subjects included in cognitive interviews

Description:

Approximately 9 subjects with COPD will be involved in cognitive interviews and will be asked to respond to all of the items in the draft item set.

Treatment:

Other: Draft item set

Subjects included in candidate item set

Description:

Approximately 150 subjects with COPD will respond to the questions in candidate item set.

Treatment:

Other: Candidate item set