Moderate to severe chronic obstructive pulmonary disease
Conditions
Interventions
Expectoration group:Internet of Things respiratory rehabilitation trainer sputum training and usual care
Follow-up control group:Usual care
Pulmonary rehabilitation exercise group:Internet of Things Respiratory Rehabilitation Trainer Home Training and usual care
Medication delivery device medication group:Automatic aerosol dispenser administration and usual care
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 35-80 years who meet the diagnostic criteria for COPD. 2. The usual residence is the resident of the area where the research centres are located. 3. On the day of enrollment, the pulmonary function test report showed that after inhaling a bronchodilator (such as 400µg of salbutamol) for 15-30 minutes, FEV1/FVC of the patient less than 0.70 and FEV1% predicted between 30-80%. 4. Within 12 months, there have been two or more moderate / one or more severe acute exacerbations, supported by clinical records. 5. There was no acute exacerbation for 4 consecutive weeks. 6. The applicant or his/her family members living with him or her have a smartphone and are proficient in using the mobile app. 7. Willing to sign informed consent and actively cooperate with follow-up work.
Exclusion criteria
Exclusion criteria: 1.Complicated with important diseases other than COPD; A significant disease was defined as one that the investigator considered to be associated with a disease or severity of the disease that might put the patient at risk for participating in the study, might affect the study results, or significantly affect the patient's ability to participate in the study. He suffered from myocardial infarction, stroke, and shock in the past 3 months; 2.Patients with clinically significant abnormalities in laboratory tests (such as blood routine, blood biochemistry, and urine routine) were defined as important diseases in the last exclusion criteria; 3.Complicated with clinically significant pneumoconiosis and other restrictive ventilation dysfunction diseases; 4.Combined with uncured or advanced malignant tumors; 5.Complicated with active pulmonary tuberculosis; 6.Patients with life-threatening pulmonary embolism, clinically significant a1-antitrypsin deficiency or cystic fibrosis; 7.History of lobectomy; 8.Inability to complete the 6-minute walk test alone; 9.Meet the absolute contraindication of pulmonary function test; 10.Participated in other respiratory clinical trials within 3 months before screening; 11.Patients with uncontrolled hypertension (systolic blood pressure >180mmHg, diastolic blood pressure >110mmHg) or uncontrolled hyperglycemia considered by the investigator to be unsuitable for clinical study or there is a high risk of pulmonary bulla. 12.Exclusion criteria during the follow-up period: During the screening period or after enrollment, participants who met any of the following criteria were not eligible for the follow-up period * : (1) Concurrent acute diseases requiring intervention and affecting the study; (2) The required inspection items were not completed according to the requirements, which resulted in the inability to evaluate the main indicators; (3) Serious adverse events requiring withdrawal from the trial according to the investigator's judgment during the follow-up period; (4) Pregnancy during follow-up; (5) Withdrawal, loss of follow-up, or death during follow-up; (6) If the subjects did not meet any of the inclusion criteria or met any of the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of moderate to severe AECOPD (times/year/person);Change from baseline in maximal inspiratory pressure (MIP).; | — |
Secondary
| Measure | Time frame |
|---|---|
| The compliance rate of medication treatment according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD2025) guidelines in stable phase;The clinical features of COPD patients who have two or more moderate / one or more severe acute exacerbations;Time to first onset of moderate or severe COPD exacerbation event;Changes from baseline in FEV1, FVC, FEV1/FVC and MMEF after bronchodilation tests;The change of COPD Assessment Test (CAT) score from baseline;Induced sputum cytology;Change from baseline in Six-Minute-Walk-Distance (6MWD);The change of dyspnea scale (modified British Medical Research Council, mMRC) score from baseline;Adherence to inhaled therapy in patients with moderate to severe COPD during the follow-up period;The treatment compliance rate of acute exacerbation according to the recommended medication regimen of the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD2025) guidelines.;Change from baseline in Miller sputum cough score;Frequency of acute exacerbations of COPD of any severity (number/year/person); | — |
Countries
China
Contacts
Public ContactQin Yinyin
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed