Last updated: 10/24/2024 12:10:13
Chronic obstructive pulmonary disease (COPD) maintenance treatment patterns in China
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: COPD disease burden, patient characteristics, maintenance treatment patterns and factors influencing treatment decisions in China Tier 2 and Tier 3 hospitals
Trial description: This observational study will be conducted in COPD participants in Tier 2 and 3 hospitals in China to gain an understanding of the complex COPD management and physician’s treatment strategy.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants by each COPD maintenance treatment
Timeframe: Up to 3 months
Secondary outcomes:
Percentage of participants with disease severity and socio-economic factors by each COPD maintenance treatment
Timeframe: Baseline (Day 1)
Percentage of participants whose prescribed maintenance treatment is stepped up (adding another maintenance treatment), stepped down (withdraw any of, switched, stopped (stop all maintenance treatment) or remained the same
Timeframe: Up to 3 months
Percentage of participants by their Modified British Medical Research Council (mMRC) score at Baseline
Timeframe: Baseline (Day 1)
Percentage of participants by their COPD assessment test (CAT) score
Timeframe: Up to 3 months
Number of participants with history of exacerbations within 1 year prior to Baseline visit
Timeframe: Within 1 year prior to Baseline visit (Day 1)
Percentage of participants receiving each treatment class at 3 months
Timeframe: At 3 months
Interventions:
Other: Prospective observational cohort study
Enrollment:
1507
Observational study model:
Cohort
Primary completion date:
2022-03-11
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
Not applicable
Study date(s)
April 2021 to February 2023
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Male or female participants with minimum 40 years of age.
- A diagnosis of COPD confirmed by spirometry (According to Global initiative for chronic obstructive lung disease [GOLD] 2019 criteria) in Tier 2 and Tier 3 hospitals.
- Current primary diagnosis of asthma, active tuberculosis, bronchiectasis, lung cancer or other active pulmonary disease.
- Other unstable diseases or cognitive behavior, which could influence CAT and lung function results (judged by physicians).
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female participants with minimum 40 years of age.
- A diagnosis of COPD confirmed by spirometry (According to Global initiative for chronic obstructive lung disease [GOLD] 2019 criteria) in Tier 2 and Tier 3 hospitals.
- In hospitalized participants, recruit only participants who receive any intravenous therapy.
- A signed and dated written informed consent.
- Participants can communicate normally.
Exclusion criteria:
- Current primary diagnosis of asthma, active tuberculosis, bronchiectasis, lung cancer or other active pulmonary disease.
- Other unstable diseases or cognitive behavior, which could influence CAT and lung function results (judged by physicians).
- Experienced a moderate/severe COPD exacerbation treated by a physician within last 1 month.
- Currently participating in another COPD clinical study, which provides the participant investigational medication and/or disease management.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2022-03-11
Actual study completion date
2023-06-02
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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