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Japan COPD Exacerbation Cognitive study

Generation and Cognitive Testing of Informative and Suitable Items for a COPD Exacerbation Recognition Tool (CERT) for Detection of Exacerbations of COPD in Japanese Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080224526
Enrollment
150
Registered
2019-01-17
Start date
2019-02-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic obstructive pulmonary disease)

Interventions

Sponsors

GlaxoSmithKline K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients having COPD attending the outpatient respiratory specialist sites for their disease will be informed about the study and will be invited to join the trial. To be eligible for inclusion, each subject must fulfil ALL of the following criteria: 1. Male or female of age over 40 years 2. Spirometrically confirmed COPD or ACOS according to diagnostic criteria in GOLD document 3. Smoking history (over 10 pack-years) 4. A treated exacerbation of COPD within 12 months prior to the study visit 5. Willing and able to provide informed consent, and able to participate focus groups or cognitive interviews. (Translation will be provided for illiterate participants to provide informed consent)

Exclusion criteria

Exclusion criteria: All patients meeting ANY of the exclusion criteria will be excluded. 1. Current diagnosis of asthma or clinically relevant bronchiectasis. Note: patients with Asthma COPD Overlap Syndrome (ACOS) ARE eligible 2. Patients 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 investigators opinion, would place patients at risk or interfere with study evaluation or affect participation in the study

Design outcomes

Primary

MeasureTime frame
other Items (word/phrase) which is used in the communication tool for COPD exacerbations between physicians and patients

Secondary

MeasureTime frame
other -

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026