Acute Exacerbation of Chronic Obstructive Pulmonary Disease, classified according to Anthonisen classification
Conditions
Interventions
Group A:Type III AECOPD: oral steroids (Cortisone, 30mg, QD), 5-day course
Inhaled steroids (budesonide, 2mg, BID), 5-day course
QD), 5-day course.
Group B:Type II AECOPD: Oral steroids (Cortisone, 30mg, QD), 7-day course
Inhaled steroids (budesonide, 2mg, BID), 7-day course.
Group C:Type I AECOPD: Respiratory quinolones (moxifloxacin, 400mg, iv drip, 2nd generation cephalosporin+macrolides (cefuroxime axetil iv drip 1.5g BID+azithromycin 0.5 iv drip QD), 5-day course.
Sponsors
1st Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Test subjects are defined as male or female older than 40 years of age diagnosed with COPD. Pulmonary function test after inhalation of bronchodilator shows FEV1<80% of normal prediction, FEV1/FVC<70%. AECOPD accords with 2003 GOLD Standard: 1. At least two new onsets of major symptoms: (1) dyspnea; (2) purulent sputum (3) increased sputum production; 2. Any major symptom plus at least one minor symtpoms: (1) upper respiratory tract infection in the past 5 days; (2) exacerbated wheezin; (3) increased respiration rate or 20% increment of baseline in heart rate; (4) worsened cough; (5) fever for no other cause; 3. The above conditoins have lasted for more than 2 days. Anthonisen Classification: Type I: With 3 major symtpoms; Type II: With 2 of the 3 major symptoms; Type III: Any major symptom plus at least one minor symptom: (1) upper respiratory tract infection in the past 5 days; (2) exacerbated wheezin; (3) increased respiration rate or 20% increment of baseline in heart rate; (4) worsened cough; (5) fever for no other cause.
Exclusion criteria
Exclusion criteria: 1. X-ray presents findings consistent with pneumonia; 2. Identified or suspected allergic reactions or intolerance of the following drugs: cefuroxime axetil, azithromycin, moxifloxacin, or other cephalosporins, macrolides or quinolones; 3. Past history of immunologic diseases, including: (1) Baseline absolute neutrophil count (ANC)=3 times of normal upper limit; 11. Having received treatment of experimental drugs within 30 days before baseline visit; 12. Past participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| health-related quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| COPD symptom score (recorded on diary cards)/BODE score;FEV1(1day before and 1 day after treatment), IC, IC/TLC; PEF(early morning and at night);FVC(1day before and 1 day after treatment);Clinical cure rate and bacteria elimination rate of AECOPD; | — |
Countries
China
Contacts
Public ContactCanmao Xie
Outcome results
None listed