Skip to main content
. 2021 Nov 22;2021(11):CD002997. doi: 10.1002/14651858.CD002997.pub5

Amayasu 2000.

Study characteristics
Methods Design: randomised controlled, double‐blind, cross‐over study
Statistical analysis: Student's paired T‐test
Duration: 8 weeks per treatment with 4‐week washout
Conducted in Yokohama, Japan, and Boston, USA
Participants Population: 17 participants randomised to 2 treatment sequences (clarithromycin‐placebo and placebo‐clarithromycin)
Baseline characteristics: reported for population as a whole, since the study was a cross‐over design
% male: 52.9
Mean age, years: 38.5
% on maintenance ICS: 0
% on maintenance LABA/ICS: 0
Mean % predicted FEV1: 76.2
Mean daily ICS dose, µg: 0
Chlamydophila infection: not reported
Inclusion criteria: non‐smokers, aspirin tolerant, with mild or moderate asthma diagnosed according to the criteria of the ATS. All were in stable condition and had been free of symptoms for respiratory infections for ≥ 6 weeks.
Exclusion criteria: people using oral or ICSs, theophylline, any anti‐leukotriene drug, any other anti‐inflammatory agents or clarithromycin
Interventions Run‐in: wash‐out period ≥ 4 weeks between cross‐over
Intervention: clarithromycin 200 mg twice per day
Control: matching placebo
Outcomes Blood eosinophils, blood neutrophils, serum ECP, sputum eosinophils, sputum neutrophils, sputum ECP, symptom score, FVC, FEV1, methacholine challenge
Notes Funding: Aoki International Co, Ltd
Study ID(s): not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomly assigned, no details.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Placebo of identical appearance used; described as double‐blind.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not described.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No mention of dropouts.
Selective reporting (reporting bias) Unclear risk Reported outcomes could be used in analysis, but unclear if others were missing (protocol registration not reported).
Other bias Low risk None noted.