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Japan COPD Exacerbation Cognitive study

Not Applicable
Completed
Conditions
COPD (Chronic obstructive pulmonary disease)
Registration Number
JPRN-jRCT1080224526
Lead Sponsor
GlaxoSmithKline K.K.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
150
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
other<br>Items (word/phrase) which is used in the communication tool for COPD exacerbations between physicians and patients
Secondary Outcome Measures
NameTimeMethod
other<br>-
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