Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Treatment group:Treatment with Bechlorvogel inhalation aerosol.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. A signed and dated written informed consent is obtained prior to participation. 2. Age >= 40 years with no gender restrictions. 3. Diagnosed with Group E COPD according to GOLD 2024. 4. Participants have good understanding and cooperation ability during the trial process and can correctly use the device after training.
Exclusion criteria
Exclusion criteria: 1. Moderate or severe exacerbation of disease (requiring oral corticosteroid, antibiotics or hospitalization) within the last 8 weeks. 2. Participants currently have lung diseases other than chronic obstructive pulmonary disease, including pneumoconiosis, asthma, bronchiectasis, allergic pneumonia, active pulmonary tuberculosis, sarcoidosis, allergic bronchopulmonary aspergillosis, or a history of lung cancer, etc. 3. Suffer from severe hematopoietic system, digestive system, nervous system, endocrine and metabolic diseases, or malignant tumors, and are judged by the researcher as unsuitable for inclusion. 4. Have a history of narrow-angle glaucoma, prostate hyperplasia (poorly controlled after surgical treatment or drug therapy), or bladder neck obstruction (poorly controlled after surgical treatment or drug therapy) and are judged by the researcher to avoid the use of anticholinergic drugs. 5. Pregnant or breastfeeding women or participants with positive blood/urine pregnancy test results. 6. Participants (including male participants) have plans for childbirth from the screening period to 6 months or sperm or egg donation. 7. Participants with restrictive pulmonary diseases and conditions, such as Guillain-Barré syndrome, myasthenia gravis, amyotrophic lateral sclerosis, and corticosteroid-induced myopathy who cannot perform respiratory function tests. 8. The subject is participating in any clinical study currently or within 30 days. Or subjects not suitable for inclusion in this clinical trial according to the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Small airway function (MMEF - FEF25-75%/MEF50/MEF25); | — |
Secondary
| Measure | Time frame |
|---|---|
| Small airway function (MMEF - FEF25-75%/MEF50/MEF25);large airway function (FEV1, FEV1/FVC);Diffusion function (DLco);Fres, R5-R20;Symptom;Chest CT (emphysema, small airways, interstitial) scores;Sputum inflammation.;Safety; | — |
Countries
China
Contacts
Public ContactZhang Min
Shanghai General Hospital
Outcome results
None listed