Lam 1989.

Methods	Aims: to compare the effectiveness of oral amoxicillin and oral ofloxacin for infective exacerbations in non‐cystic fibrosis bronchiectasis Design: randomised, double‐blind, placebo‐controlled trial. Each arm received the active intervention plus a dummy of the comparator intervention (i.e. double dummy). Total study duration: not reported Number of study centres and locations: single, Hong Kong Study setting: hospital Methods of recruitment: not reported Withdrawals: none Study start and end dates: not reported Analysis by intent‐to‐treat: not reported
Participants	41 adults were randomised. Inclusion criteria: hospitalised adults with an infective exacerbation of bronchiectasis, as evidenced by sputum turning from mucoid or mucopurulent to frankly purulent Exclusion criteria: past history of allergy to antibiotics, hepatic or renal dysfunction, or pregnancy Mean age: ofloxacin (OG): 53.1 years; range: 22 to 74; amoxicillin (AG): 52.8 years; range: 28 to 65 Gender: OG: 9 females, 11 males; AG: 9 females, 12 males Bronchiectasis diagnosis: in most patients (34), diagnosis of bronchiectasis was confirmed by clinical and radiological evidence of bronchial wall thickening or cystic changes; in 7 patients, it was confirmed clinically and by bronchogram. Definition of acute exacerbation: sputum turning from mucoid or mucopurulent to frankly purulent Severity of condition: All participants had moderate to severe airflow obstruction. Almost all participants had cystic changes on chest radiographs. History of bronchiectasis, years (mean): OG: 14.1 years; range: 3 to 60; AG: 14.7 years; range: 2 to 50 Mean episodes of exacerbations per participant in previous year requiring antibiotics: OG: 3.3; AG: 3.8 Sputum production daily between exacerbations (n): OG: 15; AG: 17 Baseline lung function mean (SD): FEV₁ (L): OG: 0.97 (0.57); AG: 0.91 (0.49); FEV₁ (% predicted): OG: 42.1%; AG: 39.8%; FEV₁/FVC: OG: 59.5 (16.9); AG: 58.0 (19.5) Smoking history: current: OG: 2; AG: 2; former: OG: 8; AG: 9; non‐smoker: OG: 10; AG: 10 Baseline imbalances: none reported
Interventions	Treatment started from the day of admission to hospital OG: ofloxacin plus amoxicillin placebo tablets (n = 20) Dose: 200 mg; delivery mode: oral; frequency: 3 times daily; duration: 10 days Co‐intervention: postural drainage and other prescribed treatment including bronchodilators as required AG: amoxicillin plus ofloxacin placebo tablets (n = 21) Dose: 1000 mg; delivery mode: oral; frequency: 3 times daily; duration: 10 days Co‐intervention: postural drainage and other prescribed treatment including bronchodilators as required
Outcomes	Temperature, sputum appearance and volume, haemoptysis, cough and dyspnoea: daily Spirometry and chest radiology: days 0 and 10 Haematological and biochemical tests, and sputum for gram smears and cultures: days 0, 5, and 10. Antibiotic levels in serum and sputum at 2 hours post dosage determined by a disc‐plate bioassay: day 5. Sputum purulence: day 10 Side effects: daily
Notes	Power calculation: not reported Trial registration: not reported Conflict of interest: not reported Funders: Daiichi Seiyaku Co Ltd provided the active and matched placebo tablets. Role of the sponsors: not reported Ethical approval: not reported Conclusions: The role of oral ofloxacin in infective episodes of bronchiectasis appears to be promising. It would be a useful alternative antibiotic for empirical initial treatment on an outpatient basis. Further studies are required to define the optimal dosage ad duration of therapy and to define its role as compared to high‐dose or nebulised amoxicillin.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to permit judgement of 'low risk' or 'high risk'
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement of 'low risk' or 'high risk'
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind, double‐dummy design
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement of 'low risk' or 'high risk'
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants were assessed at the end of treatment.
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement of 'low risk' or 'high risk'
Other bias	High risk	Study authors note that high levels of H influenzae, K pneumoniae, and P aeruginosa may be attributable to previous exposure to ampicillin and other antibiotics.

AG: amoxicillin group.

CF: cystic fibrosis.

CFUs: colony‐forming units.

CG: ciprofloxacin group.

FEV1: forced expiratory volume in one second.

FVC: forced vital capacity.

H influenzae: Haemophilus influenzae.

K pneumoniae: Klebsiella pneumoniae.

NCFB: non cystic fibrosis bronchiectasis

OG: ofloxacin group.

P aeruginosa: Pseudomonas aeruginosa.