Last updated: 02/09/2022 10:30:11

Accurate recognition of exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
201098
See study documents
Clinicaltrials.gov ID
NCT03170999
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Generation and Cognitive Testing of Informative and Suitable Items for a COPD Exacerbation Recognition Tool (CERT) for Detection of Exacerbations of COPD in Chinese Patients
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

COPD symptom item set to identify common phrases of COPD exacerbation

Timeframe: Day 1

Preparation of COPD Exacerbation Recognition tool (CERT)

Timeframe: Day 1

Secondary outcomes:
Not applicable
Interventions:
  • Other: Focus group interview
  • Other: Draft item set
  • Other: Candidate item set
    • Enrollment:
    199
    Primary completion date:
    2020-29-05
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Paul W Jones, Chanzheng Wang, Ping Chen, Liping Chen, Daoxin Wang, Junbo Xia, Yang Yang, Yingyu Wang, and Qianli Ma.The development of a COPD exacerbation tool (CERT) to help patients recognize when to seek medical advice.Int J Chron Obstruct Pulmon Dis.2022;:213-222 DOI: NULL PMID: NULL
    Medical condition
    Airway Obstruction
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    January 2018 to May 2020
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • 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.
    • 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.
    Inclusion and exclusion criteria
    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 location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Chongqing, China, 400010
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hangzhou, Zhejiang, China, 310000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Shenyang, China, 110000
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2020-29-05
    Actual study completion date
    2020-29-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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