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This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | placebo |
| |
| azithromycin SR (Zithromax; compound: CP-62,993) |
| Measure | Description | Time Frame |
|---|---|---|
| sponsor assessment of clinical response in the Clinical Per Protocol population | Test of Cure (TOC) visit (Day 14-21) |
| Measure | Description | Time Frame |
|---|---|---|
| investigator assessment of clinical response in the Clinical Per Protocol population | TOC visit | |
| bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population | TOC visit |
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Inclusion Criteria:
Adult patients with a history of chronic bronchitis (i.e., chronic cough and sputum production on most days for 3 consecutive months for more than 2 years) and current evidence of an acute bacterial exacerbation of their disease, as demonstrated by production of purulent sputum and the presence of at lest 2 of the following signs and symptoms, were included: increased sputum production, increased dypsnea, increased cough, or increased sputum purulence.
Exclusion Criteria:
Key exclusion criteria were treatment with any systemic antibiotic within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; a chest radiograph consistent with pneumonia; and previously diagnosed conditions which tend to mimic or complicate the course and evaluation of the infectious process (e.g., bronchiectasis, lung abscess or empyema, active TB, pulmonary malignancy, cystic fibrosis).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35215 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Drug |
azithromycin 2.0 g by mouth in the form of a slurry for 1 dose |
|
| placebo | Other | placebo |
|
| levofloxacin | Drug | 500 mg (two 250 mg capsules) by mouth once daily for 7 days |
|
| sponsor assessment of clinical response in the Clinical Per Protocol population | Long-Term Follow-Up (LTFU) visit (Day 28-35) |
| Summary of baseline susceptibilities | Study Endpoint |
| adverse events | Continuous |
| clinical laboratory tests | Baseline and EOT visit |
| sponsor assessment of clinical response in the Clinical Per Protocol population | End of Treatment (EOT) visit (Day 8-11) |
| sponsor assessment of clinical response in the remaining study populations | TOC visit |
| sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population | EOT visit and TOC visit |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Pfizer Investigational Site | Columbiana | Alabama | 35051 | United States |
| Pfizer Investigational Site | Tallassee | Alabama | 36078 | United States |
| Pfizer Investigational Site | Mesa | Arizona | 85201 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85014 | United States |
| Pfizer Investigational Site | Tempe | Arizona | 85282 | United States |
| Pfizer Investigational Site | Daytona Beach | Florida | 32114 | United States |
| Pfizer Investigational Site | Merritt Island | Florida | 32953 | United States |
| Pfizer Investigational Site | Austell | Georgia | 30106 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47712 | United States |
| Pfizer Investigational Site | Madisonville | Kentucky | 42431 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70115 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49009 | United States |
| Pfizer Investigational Site | Royal Oak | Michigan | 48073 | United States |
| Pfizer Investigational Site | Olive Branch | Mississippi | 38654 | United States |
| Pfizer Investigational Site | Elkhorn | Nebraska | 68022 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68105 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68144 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43214 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43215 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43222 | United States |
| Pfizer Investigational Site | Allentown | Pennsylvania | 18102 | United States |
| Pfizer Investigational Site | Harrisburg | Pennsylvania | 17011 | United States |
| Pfizer Investigational Site | Harrisburg | Pennsylvania | 17110 | United States |
| Pfizer Investigational Site | Morrisville | Pennsylvania | 19067 | United States |
| Pfizer Investigational Site | Willow Grove | Pennsylvania | 19090 | United States |
| Pfizer Investigational Site | Milan | Tennessee | 38358 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78224 | United States |
| Pfizer Investigational Site | Curitiba | Paraná | 80060-900 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-002 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-074 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Pfizer Investigational Site | Santo André | São Paulo | 09060-650 | Brazil |
| Pfizer Investigational Site | Edmonton | Alberta | T5A 4L8 | Canada |
| Pfizer Investigational Site | Edmonton | Alberta | T5N 2N8 | Canada |
| Pfizer Investigational Site | Sydney | Nova Scotia | B1S 1A9 | Canada |
| Pfizer Investigational Site | Hawkesbury | Ontario | K6A 1A1 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| Pfizer Investigational Site | Ste-Foy | Quebec | G1V 4G5 | Canada |
| Pfizer Investigational Site | North Battleford | Saskatchewan | S9A 0V6 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| Pfizer Investigational Site | Desamparados | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Guadalupe | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Pavas | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Pinares de Curridabat | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | San José | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Uruca | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Berlin | 10965 | Germany |
| Pfizer Investigational Site | Rathenow | 14712 | Germany |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 034 | India |
| Pfizer Investigational Site | Elamakkara, Cochin | Kerala | 682 026 | India |
| Pfizer Investigational Site | Indore | Madhya Pradesh | 452 001 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 053 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141 001 | India |
| Pfizer Investigational Site | Coimbatore | Tamil Nadu | 641022 | India |
| Pfizer Investigational Site | Alytus | LT-4580 | Lithuania |
| Pfizer Investigational Site | Klaipėda | LT-5800 | Lithuania |
| Pfizer Investigational Site | Vilnius | LT-2010 | Lithuania |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| Pfizer Investigational Site | Eindhoven | 5623 EJ | Netherlands |
| Pfizer Investigational Site | Moscow | 105077 | Russia |
| Pfizer Investigational Site | Moscow | 105229 | Russia |
| Pfizer Investigational Site | Moscow | 107066 | Russia |
| Pfizer Investigational Site | Moscow | 119048 | Russia |
| Pfizer Investigational Site | Moscow | Russia |
| Pfizer Investigational Site | Smolensk | 214019 | Russia |
| Pfizer Investigational Site | Madrid | 28006 | Spain |
| Pfizer Investigational Site | Madrid | 28007 | Spain |
| Pfizer Investigational Site | Málaga | 29010 | Spain |
| Pfizer Investigational Site | Atherstone | Warwickshire | CV9 1EU | United Kingdom |
| Pfizer Investigational Site | Leeds | West Yorkshire | LS12 1JE | United Kingdom |
| Pfizer Investigational Site | Glasgow | G45 9AW | United Kingdom |
| Pfizer Investigational Site | Caracas | Venezuela |
| ID | Term |
|---|---|
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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