N/A
N=1,507
Chronic Obstructive Pulmonary Disease (COPD) Maintenance Treatment Patterns in China
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT04853238 ↗Enrolled (actual)
1,507
Serious AEs
0.7%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline — 735; 68; 554; 105 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Prospective observational cohort study (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline |
735; 68; 554; 105; 3; 13 | — |
| PRIMARY Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months |
685; 57; 433; 95; 6; 26 | — |
| PRIMARY Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) |
17; 3; 0; 1; 3; 2 | — |
| PRIMARY Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) |
537; 29; 0; 63; 131; 196 | — |
| SECONDARY Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline |
1.424; 1.405; 1.137 | — |
| SECONDARY Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline |
13; 15; 0; 36; 11; 26 | — |
| SECONDARY Number of Participants With COPD Medication History |
523; 38; 476; 75; 0; 15 | — |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point |
12.4; 19.5; 27.0; 13.1; 16.8; 18.7 | — |
| SECONDARY Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point |
1.2; 2.1; 2.0; 1.4; 1.8; 2.0 | — |
| SECONDARY Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group |
503; 49; 5; 58 | — |
| SECONDARY Number of Participants With at Least One Co-morbidity |
512; 52; 571 | — |
| SECONDARY Number of Participants by Their Socio-economic Characteristics |
38; 1; 40; 219; 27; 187 | — |
| SECONDARY Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points |
300; 20; 109; 318; 32; 250 | — |
| SECONDARY Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline |
127; 14; 37; 279; 17; 130 | — |
| SECONDARY Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same |
67; 4; 180; 26; 1; 14 | — |
| SECONDARY Number of Participants Receiving COPD Maintenance Treatment at 3 Months |
92; 6; 20; 127; 12; 35 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04853238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.