title: Esberitox N as supportive therapy when providing standard antibiotic treatment in subjects with a severe bacterial infection (acute exacerbation of chronic bronchitis). A multicentric, prospective, double-blind, placebo-controlled study.
abstract: 53 patients with planned antibiotic therapy for the treatment of acute exacerbation of chronic bronchitis as an example of a severe bacterial infection requiring antibiotics were included in a prospective, multicentre, double-blind, placebo-controlled study. The chronic bronchitis was staged by forced expiratory volume of the 1st second (FEV(1)) measured in the infection-free interval prior to the current episode and had to be between 35 and 75% for the predicted value. Patients were randomly assigned to receive newer macrolide antibiotics plus either Esberitox N or placebo. Antibiotic therapy was administered according to generally accepted guidelines and Esberitox N or placebo was given for 28 days. The baseline-adjusted means for FEV(1) (%) on day 10 were 68.7 points for the Esberitox N group and 59.2 points for the placebo group (p = 0.0303). For FEV(1) the difference between the two treatment groups was 267 ml (p = 0.0499). The time to half maximal improvement was 5.7 days in the Esberitox N group compared to 12.8 days in the placebo group. The treatment was well tolerated; no serious adverse events were documented. In conclusion, comedication of antibiotics with Esberitox N in subjects with acute exacerbation of chronic bronchitis seems to be of benefit for the patient. Apparently, therapy with Esberitox N leads to a faster recovery from this severe bacterial infection, possibly via preventing an impairment of the host's immune system which might otherwise occur as a consequence of aggressive antimicrobial therapeutics.
authors.affiliation: EPA-Europharma Auftragsforschung, Kronberg, Germany.
authors.forename: Wilfried
authors.initials: W
authors.lastname: Hauke
authors.forename: Gert
authors.initials: G
authors.lastname: Köhler
authors.forename: Hans-Heinrich
authors.initials: HH
authors.lastname: Henneicke-Von Zepelin
authors.forename: Johannes
authors.initials: J
authors.lastname: Freudenstein
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017963:Azithromycin / Q000627:therapeutic use; D001424:Bacterial Infections / Q000150:complications / Q000188:drug therapy*; D029481:Bronchitis, Chronic / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D002908:Chronic Disease; D017291:Clarithromycin / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D008173:Lung Diseases, Obstructive / Q000150:complications* / Q000188:drug therapy*; D010865:Pilot Projects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D015575:Roxithromycin / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000276:Adjuvants, Immunologic; D000900:Anti-Bacterial Agents; D010936:Plant Extracts; D015575:Roxithromycin; C026057:Esberitox; D017963:Azithromycin; D017291:Clarithromycin