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 |
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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 |
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Interventions |
Run‐in: wash‐out period ≥ 4 weeks between cross‐over Intervention: clarithromycin 200 mg twice per day Control: matching placebo |
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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 |
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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. |