A multicenter double-blind randomized trial was performed in 22 teaching hospitals to compare the clinical effectiveness of the combination of
amoxicillin (CAS 26787-78-0) plus
bromhexine (CAS 3572-43-8) versus
amoxicillin alone given 4 times a day for 5 to 7 days in the treatment of clinically diagnosed community-acquired bacterial lower
respiratory tract infections. 392 adult patients diagnosed clinically to have acute
bronchitis or
pneumonia of bacterial etiology were recruited for the study with 192 subjects given
amoxicillin (250 mg) plus
bromhexine (8 mg) (
Drug AB) and 200 receiving
amoxicillin (250 mg) (
Drug AA) alone 4 times a day for 5 to 7 days. Clinical response, improvement in symptom scores using a visual analogue scale, and bacteriologic response were monitored at Days 3, 5 and 7 of treatment. Results showed that although 180/192 (94%) given
Drug AB and 185/200 (93%) given
Drug AA had favorable clinical response at the end of treatment, the
infection was completely resolved for 89/192 (46%) among the
Drug AB group and in 67/200 (34%) of patients on
Drug AA (p = 0.022). Also, patients given
Drug AB had significantly greater reduction of their symptom scores at Day 3 for symptoms of
cough discomfort,
cough frequency, ease of expectoration and sputum volume. Among the subset of patients with
pneumonia, the cure rates for
Drug AB and
Drug AA were 24/50 (47%) and 11/50 (22%), respectively (p = 0.008). A respiratory pathogen was cultured in only 72/392 (18%) of subjects.(ABSTRACT TRUNCATED AT 250 WORDS)