| Methods |
Location: The Netherlands. This study was a part of unpublished international multicentre study
Participants were randomised to receive either azithromycin or amoxycillin. Block randomisation was done by Pfizer‐Euroclin, Brussels, Belgium. Double‐blinding was performed with matched placebo tablets. Participants were clinically evaluated on days 5 to 7 and 12 to 15 |
| Participants |
50 in‐ and outpatients aged 18 years or older with acute exacerbation of chronic bronchitis were recruited. Chronic bronchitis was clinically defined as having 3 levels of severity. Type I exacerbation (most severe grade), type II exacerbation (less severe grade) and type III exacerbation (least severe grade). Participants with a terminal illness or concomitant use of antibiotics within 48 hours prior to treatment were excluded. Participants: azithromycin group N = 25, amoxycillin group N = 25 |
| Interventions |
1. Azithromycin 500 mg once daily for 3 days
2. Amoxicillin 500 mg 3 times daily for 5 days |
| Outcomes |
Cure
Improvement
Failure
Pathogen eradication |
| Notes |
All 50 randomised participants were analysed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Block randomisation was done at Pfizer‐Euroclin, Brussels, Belgium |
| Allocation concealment (selection bias) |
Low risk |
Quote: "In this double‐blind study, patients were randomized to receive either azithromycin at a dosage of 500 mg (two 250‐mg capsules) once daily for 3 days or amoxicillin at a dosage of 500 mg (two 250‐mg capsules) three times daily for 5 days." Block randomisation was done at Pfizer‐Euroclin, Brussels, Belgium |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Matched placebo was used. Quote: "Each patient received six capsules per day (six amoxicillin capsules or two azithromycin capsules plus four placebos)" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All 50 randomised participants were analysed |
| Selective reporting (reporting bias) |
Unclear risk |
The study protocol is not available |
| Other bias |
Unclear risk |
Baseline characteristics were comparable between the 2 treatment groups |
