Chronic obstructive pulmonary disease
Conditions
Interventions
Novel drug delivery set group:New drug delivery devices and usual care
Pulmonary rehabilitation exercise group:Pulmonary rehabilitation exercise and usual care
Combined intervention group:Pulmonary rehabilitation exercise and Novel drug delivery set and usual care
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 40-75 years who meet the diagnosis of chronic obstructive pulmonary disease (COPD) (pulmonary function reports show that after inhaling bronchodilators (15-30 minutes after inhaling 400 µ g of salbutamol), FEV1/FVC<0.70), And the percentage of FEV1 to the expected value is between 30% (i.e. GOLD levels 1-3); 2. Patients aged 40-75 years who meet the diagnosis of lung cancer and have an ECOG PS score of <= 2, with an estimated survival period greater than 6 months; 3. Upon initial diagnosis of advanced non-small cell lung cancer, routine anti-tumor treatment is planned after evaluation by the attending physician; 4. No acute exacerbation has occurred within 4 consecutive weeks; 4. Sign the informed consent form, understand and actively cooperate with the follow-up work.
Exclusion criteria
Exclusion criteria: 1. Complicated with important diseases other than COPD and lung cancer; Important disease is defined as: co-occurrence of a certain disease or severity of disease considered by the investigator may cause the patient to be at risk due to participation in the study, or may affect the study results, or significantly affect the patient's ability to participate in the study; 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) are defined as important diseases in exclusion criteria (1) if abnormal; 3. Complicated with clinically significant pneumoconiosis and other restrictive respiratory dysfunction diseases; 4. Combined with active pulmonary tuberculosis; 5. Patients with life-threatening pulmonary embolism, clinically significant alpha 1-antitrypsin deficiency or cystic fibrosis; 6. History of lobectomy; 7. Lower limb mobility disorder, inability to complete the six-minute walk test assessment alone; 8. Complies with absolute contraindications for pulmonary function tests; 9. Participation in other respiratory clinical trials within 3 months prior to screening; 10. Patients considered by the investigator to be unsuitable for clinical study, such as uncontrolled hypertension (systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg), uncontrolled hyperglycemia, pulmonary bullae with high risk, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;respiratory muscle strength;Frequency of AECOPD (times/year/person); | — |
Secondary
| Measure | Time frame |
|---|---|
| Dyspnea (mMRC) score;Pulmonary function test;Six Minute Walk Test (6MWT);Lung Cancer Treatment Functional Assessment Scale (FACT-L); | — |
Countries
China
Contacts
Public ContactQin Yinyin
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed