Chronic obstructive pulmonary disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with moderate to severe COPD; 2. Aged between 40 and 75 years; 3. Pulmonary function report on the day of enrollment showed that after inhaling bronchodilators (after inhaling 400µg of albuterol for 15-30 minutes), FEV1/FVC <0.70, and the percentage of FEV1 in the predicted value was <80% (i.e., GOLD grade 2-3); 4. More than 2 moderate acute exacerbations or more than 1 severe acute exacerbation in the past 12 months, supported by clinical medical records; 5. Sign the informed consent form, understand and actively cooperate with the follow-up work. *Subjects who meet all of the above inclusion criteria may be considered for follow-up period; Subjects who do not meet any of the above inclusion conditions should be excluded from enrollment and will not enter the follow-up period. Patients who are outside this age range and meet other inclusion conditions can also be enrolled after being assessed by the investigator.
Exclusion criteria
Exclusion criteria: 1. Age< 18 years old; 2. Pregnant patients; 3. Unconscious or bedridden for a long time, unable to complete the six-minute walk test assessment alone; 4. Combined with active tuberculosis and other infectious diseases; 5. Patients who are considered unsuitable to participate in clinical studies by the investigator. Subjects who meet any of the above exclusion conditions should be excluded from enrollment and will not enter the follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of moderate-to-severe COPD exacerbations over one year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (COPD);Change in Maximal Inspiratory Pressure (MIP) from Baseline;The frequency (number of episodes/person/year) of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) at any severity level;The change of 6-minute Walk-Distance (6MWD) relative to the baseline;The change of the COPD Assessment Test (CAT) score relative to the baseline;The change of the modified British Medical Research Council (mMRC) score relative to the baseline; | — |
Countries
China
Contacts
Shijiazhuang People's Hospital