severe emphysematous COPD
Conditions
Interventions
None listed
Sponsors
Yokohama City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The primary focus of this systematic review is on patients with severe emphysematous COPD. The term "emphysema" refers to pathological changes of the lung, while the clinical diagnosis is referred to as COPD. However, inclusion criteria strictly based on the COPD diagnosis appeared to exclude historically pivotal RCTs that enrolled patients regardless of their COPD diagnosis. Given the substantial overlap between emphysema and COPD, our study does not require patients to have an explicit COPD diagnosis as long as their clinical characteristics align with COPD.
Exclusion criteria
Exclusion criteria: For instance, studies with a mean or median forced expiratory volume in 1 second (FEV1)/forced vital capacity exceeding 70% will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary and secondary outcomes will be assessed for a "middle-term" follow-up period. The preferred follow-up time is 6 months after the intervention; however, in case where data for 6 months are missing, a substitute using the data with the longest observation between 3 and 6 months will be allowed. The co-primary outcomes include middle-term pulmonary function (mean difference [MD] in FEV1 change from baseline, in mL), quality of life (MD in St. George Respiratory Questionnaire [SGRQ] change from baseline, in points), physical activity (MD in 6-minute walking distance [6MWD] change from baseline, in meters), and mortality (risk ratio [RR] for all-cause death). A COPD specific SGRQ will not be utilized in our study. | — |
Secondary
| Measure | Time frame |
|---|---|
| With the exception of long-term survival (5-year mortality), all secondary outcomes will be assessed for a "middle-term" follow-up period. The preferred follow-up time is 6 months after the intervention; however, in case where data for 6 months are missing, a substitute using the data with the longest observation between 3 and 6 months will be allowed. Secondary outcomes include long-term mortality (RR for all-cause death over 5 years), middle-term severe/serious adverse events (SAE, RR), pneumothorax (RR), and exacerbation (RR). Variations in the definition of exacerbation such as, "acute exacerbation" will be accepted. | — |
Countries
Japan,North America
Contacts
Public ContactNobuyuki Horita
Yokohama City University Hospital Chemotherapy Center
Outcome results
None listed