Last updated: 02/09/2022 10:30:11
Accurate recognition of exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2020-29-05
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)
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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