Combined Pulmonary Fibrosis and Emphysema
Conditions
Interventions
Treatment Group:Bacterial Lysates(Staphylococcus and Neisseria Tablets )
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, aged 50 to 80 years inclusive (with a preference for male smokers); 2. Subjects must meet the definition criteria for Combined Pulmonary Fibrosis and Emphysema (CPFE) as recommended by the ATS/ERS/JRS/ALAT Research Consensus. 3. table disease condition (defined as no occurrence of acute exacerbation within 4 weeks prior to baseline). 4. Forced Vital Capacity (FVC) >= 45% of predicted value, and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) = 25% of predicted value.
Exclusion criteria
Exclusion criteria: 1. Active infection or lung cancer. 2. Reatment with systemic corticosteroids at a dose > 10 mg/day of prednisone (or equivalent), or any other immunomodulatory therapy (e.g., rituximab) within 14 days prior to enrollment. 3. Known hypersensitivity or intolerance to the active ingredients or excipients of Staphylococcus and Neisseria Tablets. 4. Current participation in another clinical trial. 5. Any condition that, in the opinion of the Investigator, renders the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized Rate of Acute Exacerbations; | — |
Secondary
| Measure | Time frame |
|---|---|
| HRCT;Change from baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score;Change from baseline in 6MWD;Change from baseline in FVC % predicted and DLCO % predicted; | — |
Countries
China
Contacts
Public ContactTing Yang
West China Hospital of Sichuan University
Outcome results
None listed