chronic obstructive pulmonary disease in stable stage complicated with osteoporosis
Conditions
Interventions
Group 1:Subjects in the experimental group received basic treatment plus oral Bufehuoxue capsule, 1.2g (4 capsules) once, 3 times a day, for 24 weeks (the duration of administration could be adjusted
Group 2:Control subjects received only basic treatment.
Note: Basic treatment includes COPD basic treatment and osteoporosis basic treatment
Set the screening period (-2-0 weeks) and four interview points: V0, V1, V2, V3 (baseline, week 4, week 12, week 24).
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 40 ~ 80 years old (including 40 years old and 80 years old), gender is not limited; 2) Meet the diagnosis of chronic obstructive pulmonary disease (COPD); 3) During screening, 15 to 25 minutes after inhaling 400µg salbutamol sulfate, FEV1/ FVC < 70% and 20%=FEV1 accounted for the expected value of % < 80%; 4) Patients with chronic obstructive pulmonary disease in the stable stage at the time of screening (refers to patients with cough, sputum, shortness of breath and other symptoms stable or mild and no acute aggravation in the past 4 weeks) and complicated with osteoporosis; 5) For patients meeting the diagnostic criteria for osteoporosis, the bone mineral density (BMD) of the axial bone (lumbar 1-4, femoral neck or total hip) or the bone mineral density of the distal 1/3 of the radius measured by dual-energy X-ray absorptiometry (DXA) was = -2.5; 6) Voluntarily participate in this clinical trial, give informed consent and sign informed consent.
Exclusion criteria
Exclusion criteria: 1) Various types of metabolic bone diseases, such as osteogenesis implasia, osteomalacia, Cushing syndrome, hyperprolactinemia, thyroid or parathyroid diseases, etc. 2) Disuse osteoporosis caused by limb deformity, disability, etc.; 3) Patients with asthma, active pulmonary tuberculosis, lung cancer, diffuse panbronchitis, pulmonary resection, lung volume reduction (within 12 months), severe bronchiectasis, primary pulmonary interstitial disease, primary pulmonary fibrosis, primary pulmonary hypertension, respiratory failure, or other active pulmonary diseases during the screening period; 4) Complicated with serious diseases of digestive system, endocrine system, nervous system, autoimmune disease or other diseases, such as severe hyperthyroidism, which the researchers judge will affect the effectiveness, safety evaluation or compliance of the subjects after enrollment; 5) Patients diagnosed with severe and critical forms of novel coronavirus pneumonia (COVID-19) within 3 months before inclusion; 6) Participating in or planning to participate in an intensive (proactive) COPD rehabilitation program (participants who maintain treatment in the rehabilitation program are eligible to participate in the study); 7) Use or need for long-term use of any non-invasive positive pressure ventilation device (subjects with sleep apnea syndrome treated with continuous positive airway pressure are allowed to participate in the study); 8) received any marketed or investigational biological product within 4 months or 5 half-lives (whichever is older) prior to screening; 9) Any item of liver function index (ALT, AST) exceeded the upper limit of normal reference value by 1.5 times, and renal function index SCR exceeded the upper limit of normal reference value by 1.2 times; 10) They have severe liver disease (such as liver tumor, cirrhosis, various types of hepatitis, etc.) or a history of drug-induced liver injury, and drugs with potential liver damage (immunosuppressants such as cyclosporine and tacrolimus, etc., and anti-tuberculosis drugs such as rifampicin and isoniazid, etc.) are being used or expected to be used during the study period, Chemotherapeutic drugs such as cyclophosphamide, methotrexate, azathioprine, etc., as well as Chinese medicines containing polygonum multiflorum, Tunoginseng, tripterygium wilfordii and other liver damage herbs); 11) hospitalization and/or antibiotic therapy and/or oral or intravenous hormone therapy are required during screening; Long-term use of oxygen therapy (> 12 hours/day) is required during the trial; 12) History of alcohol and drug abuse within 1 year before the test; 13) Have a history of allergy to the experimental drug and its excipients or emergency drugs; 14) Have intellectual disability or mental disorder; 15) Pregnant and lactating women, planning to become pregnant or unable to use effective contraceptive measures; 16) Participation in any clinical trial within 30 days prior to screening or 5 half-lives (whichever is older); 17) Combined with other conditions of absolute or relative prohibition of 6-minute walking test: such as resting heart rate > 120 beats/min, systolic blood pressure > 180mmHg and diastolic blood pressure > 100mmHg; Or limited lower limb movement to complete the 6-minute walking test; 18) The investigator considered it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in 6-minute walking distance from baseline in the V3 and V3 groups after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of acute exacerbations due to COPD in both groups during treatment;The changes of lung function indexes FVC, FEV1, FEV1/FVC and DLCO in the two groups after treatment were compared with baseline;The changes of CAT score, mMRC scale and St. George score in V2 and V3 groups after treatment were compared with baseline;The changes of bone mineral density (BMD) between the two groups after treatment were compared with baseline;The changes of serum type I procollagen amino terminal peptide (PINP) and serum type I collagen cross-linked carboxy-terminal peptide (S-CTX) were compared between the two groups after treatment;Changes in 6-minute walking distance from baseline in both V2 groups after treatment; | — |
Countries
China
Contacts
Public ContactHuang Jian‘an
The First Affiliated Hospital of Soochow University
Outcome results
None listed