Airway ObstructionNCT03170999
Accurate Recognition of Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Airway Obstruction, run by GlaxoSmithKline at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- Focus group interview, Draft item set and Candidate item set
- How many people
- 199 participants
- Where
- 3 sitesChina
- Study dates
- 29 Jan 2018to 29 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects having COPD attending the outpatient respiratory specialist clinics of tier 3 hospitals for their disease will be included in the study.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
China3 sites
GSK Investigational Site
Chongqing, 400010
GSK Investigational Site
Hangzhou, Zhejiang
GSK Investigational Site
Shenyang
About this study
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
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.
- Conditions
- Airway Obstruction
- Being tested
- Focus group interview, Draft item set, Candidate item set
- Keywords
- China, Cognitive testing, COPD exacerbation, CERT
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group interviewOther
Focus group interviews will take place to discuss the key domains of COPD exacerbation which then will be used in the formation of the draft item set.
Draft item setOther
Items that form the draft item set will be subject to cognitive debriefing. Questions in the draft item set will collect information on whether the subjects with COPD have experienced that item during an exacerbation. Changes in this draft set will result in the formation of candidate item set.
Candidate item setOther
Item reduction will be done using candidate item set and the subjects will be asked to respond to the candidate items on a 4-point scale in terms of how that item changed with the onset of the last episode. Item reduction will take into account frequency and magnitude of items, floor and ceiling items and consistency between regions. The candidate item set will then be used for generation of CERT.
| Study group | Role | What they receive |
|---|---|---|
| Subjects included in Focus groups | 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. Receives: Other: Focus group interview | |
| Subjects included in cognitive interviews | 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. Receives: Other: Draft item set | |
| Subjects included in candidate item set | Approximately 150 subjects with COPD will respond to the questions in candidate item set. Receives: Other: Candidate item set |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD symptom item set to identify common phrases of COPD exacerbation
The most frequently used items to describe the symptomatic characteristics of the onset of an exacerbation will be identified from COPD symptom item set.
Measured: Day 1
Preparation of COPD Exacerbation Recognition tool (CERT)
Two simple educational hand-outs called CERT will be prepared, one for the subjects with COPD and the other for the physicians which will help Chinese physicians and subjects in recognizing and reporting COPD exacerbations.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start29 Jan 2018
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170999
- Sponsor's protocol ID
- 201098
- Status last verified
- Jul 2020
- First submitted
- 2 May 2017
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03170999
- Acronym / sponsor ID
- 201098
- Conditions
- Airway Obstruction
- Keywords
- China, Cognitive testing, COPD exacerbation, CERT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects included in Focus groups | – | Other: Focus group interviewApproximately 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. |
| Subjects included in cognitive interviews | – | Other: Draft item setApproximately 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. |
| Subjects included in candidate item set | – | Other: Candidate item setApproximately 150 subjects with COPD will respond to the questions in candidate item set. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects having COPD attending the outpatient respiratory specialist clinics of tier 3 hospitals for their disease will be included in the study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus group interviewFocus group interviews will take place to discuss the key domains of COPD exacerbation which then will be used in the formation of the draft item set. | Other | Subjects included in Focus groups |
| Draft item setItems that form the draft item set will be subject to cognitive debriefing. Questions in the draft item set will collect information on whether the subjects with COPD have experienced that item during an exacerbation. Changes in this draft set will result in the formation of candidate item set. | Other | Subjects included in cognitive interviews |
| Candidate item setItem reduction will be done using candidate item set and the subjects will be asked to respond to the candidate items on a 4-point scale in terms of how that item changed with the onset of the last episode. Item reduction will take into account frequency and magnitude of items, floor and ceiling items and consistency between regions. The candidate item set will then be used for generation of CERT. | Other | Subjects included in candidate item set |
Primary outcome
COPD symptom item set to identify common phrases of COPD exacerbation
Time frame: Day 1
The most frequently used items to describe the symptomatic characteristics of the onset of an exacerbation will be identified from COPD symptom item set.
Preparation of COPD Exacerbation Recognition tool (CERT)
Time frame: Day 1
Two simple educational hand-outs called CERT will be prepared, one for the subjects with COPD and the other for the physicians which will help Chinese physicians and subjects in recognizing and reporting COPD exacerbations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Obstruction, run by GlaxoSmithKline at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD symptom item set to identify common phrases of COPD exacerbation (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.