None listed
Conditions
Interventions
Group 1 Type of group
BMS-284756 400 mg PO once a day for 5 days PO + Placebo for azithromycin
Group name:Group 2 Type of group
Azithromycin 500 mg / d PO on Day 1, followed by 250 mg / d on Day 2-5 + Placebo for BMS-284756
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Men or women 18 years of age or older, in whom oral therapy is indicated; • With a diagnosis of chronic bronchitis (that is, having chronic cough and sputum production most days for three consecutive months, for> two consecutive years), and clinical evidence of EABC proven by the following main symptoms: - Production of purulent sputum, determined in a preliminary sample of sputum smear by the presence of> 25 polymorphonuclear leukocytes (PMLN) per low power field; Presence of two or more of the following signs and symptoms: • increased cough and / or dyspnea, • increased sputum volume, • increased sputum purulence. • The subject or his legally authorized representative have given their informed consent in writing. • Women of childbearing age should have a negative pregnancy test in serum or urine (minimum sensitivity of 25 IU / L or equivalent units of HCG) made within 48 hours immediately prior to the start of study drug administration.
Exclusion criteria
Exclusion criteria: • Diagnosis of pneumonia confirmed by the presence of new pulmonary infiltrates on chest radiography; • Previous diagnosis of immunological disease (for example, AIDS, current neutrophil count 2.0 mg / dL (176.7 mmol / L) or requiring renal dialysis; • Current clinically significant liver disease or known values of ALT and / or AST, and / or total bilirubin> 3 times the normal maximum limit. • Use of a research agent concomitantly or within 30 days prior to admission in this study; • Previous admission in any study with BMS-284756; • Presence of any disorder or disease that may interfere with the evaluation of the study medication and / or due to which, in the opinion of the Investigator, it would not be appropriate to admit the subject in the study; • Subjects receiving terfenadine, cisapride or astemizole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Comparison of the clinical cure rates between the BMS-284756 and azithromycin regimens Measure:Efficacy of BMS-284756 Timepoints:5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Sputum Smear and Evaluation; Sputum Culture Eradication: Absence of the original pathogen from the culture of a sputum sample of good quality (ie <10 epithelial cells / low frequency field) obtained in the evaluation of the Healing Test. Persistence: Continuous presence of the original pathogen in the culture of a purulent sputum sample obtained in the Healing Test Visit. Measure:Bacteriological eradication of the pathogen. Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:It will be evaluated based on the spontaneous reports, the physical examination and the results of the laboratory tests in all the subjects who have received at least one dose of the study medication. Measure:Safety Timepoints:During all of the study ; Outcome name:Evaluation of signs and symptoms Measure:Time to improvement of the cardinal symptoms of AECB Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:Evaluation of signs and symptoms Measure:Time to resolution of the cardinal symptoms of AECB Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:Assess Activity Function Measure:Time to return to baseline functioning Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:Assessment of Time Lost from Work Measure:Time lost from work or other usual activities Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:Assessment of Health care Resource Use Measure:Total health care resource use, including treatments used for the treatment of adverse events, for the entire follow-up period, Timepoints:Pre-treatment, during treatment and after treatment | — |
Countries
Australia, Canada, Chile, Mexico, Puerto Rico, United States, Venezuela
Outcome results
None listed