Two prospective randomized, double-blind, parallel studies were carried out in Europe to compare
cefaclor advanced formulation (
cefaclor AF) with
cefaclor in the treatment of acute
bronchitis caused by susceptible pathogens. A total of 1,321 patients suffering from acute
bronchitis confirmed by clinical data and a negative chest X-ray were randomized for treatment in the two multicentre trials. Three doses of
cefaclor AF were tested: 375 mg twice daily and 500 mg twice daily were compared with
cefaclor 250 mg three times daily; and
cefaclor AF 750 mg twice daily was compared with
cefaclor 500 mg three times daily.
Duration of therapy was seven days. Assessments (complete history, physical examination, sputum specimens for culture and
Gram's stain, plus clinical and laboratory evaluations of safety) were carried out within 24 hours before the first dose, during
therapy, within 72 hours after
therapy completion and, in the 375 mg and 500 mg dose groups, 1-2 weeks after the end of
therapy. There were no significant differences between the total evaluable
cefaclor AF population and the total evaluable
cefaclor population with regard to favourable post-
therapy responses. Most favourable clinical and bacteriological response rates in the 375 and 500 mg doses were 80% or above. In the higher dose group, there was a favourable post-
therapy symptomatic response in 100% of evaluable patients, with favourable bacteriological responses in 93.3% patients receiving
cefaclor AF and 96.8% receiving
cefaclor (no significant difference). Only one serious
drug-related adverse event was reported (
anaphylactic reaction). Adverse events related to the digestive system were reported by 4.7% of the
cefaclor AF-treated patients and 4.5% of the
cefaclor-treated patients during the entire study period.
Cefaclor AF, at all three dose levels studies, was seen to be as safe as
cefaclor in the treatment of acute
bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.