Chronic Bronchitis Clinical Trial
Official title:
A Phase 3B Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial To Evaluate The Efficacy and Safety Of Azithromycin SR (Microspheres Formulation) Versus Moxifloxacin For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB).
| Verified date | November 2009 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Singapore: Health Sciences Authority |
| Study type | Interventional |
This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis
| Status | Completed |
| Enrollment | 398 |
| Est. completion date | August 2008 |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms: - Production of purulent sputum as defined by Gram stained sputum specimen - Presence of all of the following: - Increased sputum production - Increased dyspnea - Increased cough - At least two exacerbations of AECB in the past 12 months - Documented FEV1 less than 80% of predicted Exclusion Criteria: - A chest radiograph consistent with pneumonia - Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Pfizer Investigational Site | Beijing | |
| China | Pfizer Investigational Site | Beijing | |
| China | Pfizer Investigational Site | Chongqing | |
| China | Pfizer Investigational Site | Chongqing | |
| China | Pfizer Investigational Site | Guangzhou | Guangdong |
| China | Pfizer Investigational Site | Hangzhou | Zhejiang |
| China | Pfizer Investigational Site | Hangzhou | |
| China | Pfizer Investigational Site | Nanjing | Jiangsu |
| China | Pfizer Investigational Site | Shanghai | |
| China | Pfizer Investigational Site | Shanghai | |
| China | Pfizer Investigational Site | Shanghai | |
| China | Pfizer Investigational Site | Shenyang | Liaoning |
| China | Pfizer Investigational Site | Shijiazhuang | Hebei |
| China | Pfizer Investigational Site | Xi'an | Shanxi |
| China | Pfizer Investigational Site | Xi'an | Shanxi |
| Malaysia | Pfizer Investigational Site | Cheras | Kuala Lumpur |
| Malaysia | Pfizer Investigational Site | Lembah Pantai | Kuala Lumpur |
| Philippines | Pfizer Investigational Site | Manila | |
| Philippines | Pfizer Investigational Site | Manila | |
| Philippines | Pfizer Investigational Site | Quezon City | |
| Philippines | Pfizer Investigational Site | Quezon City | |
| Singapore | Pfizer Investigational Site | Singapore | |
| Singapore | Pfizer Investigational Site | Singapore | |
| Taiwan | Pfizer Investigational Site | Kuei Shan Hsiang | Taoyuan Hsien |
| Taiwan | Pfizer Investigational Site | NeiHu | Taipei |
| Taiwan | Pfizer Investigational Site | Taichung | |
| Taiwan | Pfizer Investigational Site | Taichung | |
| Taiwan | Pfizer Investigational Site | Taipei | |
| Thailand | Pfizer Investigational Site | Bangkok | |
| Thailand | Pfizer Investigational Site | Bangkok | |
| Thailand | Pfizer Investigational Site | Chiang Mai | |
| Thailand | Pfizer Investigational Site | Khon Kaen | |
| Thailand | Pfizer Investigational Site | Maerim | Chiangmai |
| Thailand | Pfizer Investigational Site | Vachira Dusit | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
China, Malaysia, Philippines, Singapore, Taiwan, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population) | Test of Cure (TOC) Visit (Day 12-19) | No | |
| Secondary | Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set) | Test of Cure (TOC) Visit (Day 12-19) | No | |
| Secondary | Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set) | Test of Cure (TOC) Visit (Day 12-19) | No | |
| Secondary | Percentage of Bacteriologic Response at Test of Cure Visit | Test of Cure (TOC) Visit (Day 12-19) | No | |
| Secondary | Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence | Number of Days | No | |
| Secondary | Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score | Test of Cure (TOC) Visit (Day 12-19) | No | |
| Secondary | Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score | Test of Cure (TOC) Visit (Day 12-19) | No | |
| Secondary | Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score | Test of Cure (TOC) Visit (Day 12-19) | No | |
| Secondary | Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score | Test of Cure (TOC) Visit (Day 12-19) | No |
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