| Methods |
STUDY DESIGN: Parallel group, multicentre (57) in 11 .countries, 2 week run in on / 52 week treatment with 2 week period off treatment at 6mths to assess BHR
RANDOMISATION: Randomised treatment allocation, method not stated
BLINDING: double blind, placebo controlled ,
WITHDRAWALS/DROP OUTS: 66
COMPLIANCE: checked verbally
CONFOUNDERS: Groups well balanced by baseline characteristics
QUALITY: Jadad 3 Cochrane B |
| Participants |
N Enrolled 627, Randomised 426, completed 360, M=262 F= 164 children Mean age 10 (range 5‐15)
BASELINE SEVERITY: Mild‐moderate asthma
INCLUSION : Clinical diagnosis asthma, >15% FEV1 reversibility to SABA or diurnal variation PEF > 15%, am PEF<85% best in run in. EXCLUSION : URTI/ LRTI/hospitalisation / changed asthma medication <4 weeks, requiring OS/ anticholinergics/ methylxanthines at entry |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
PLACEBO: BD
DEVICE: DP diskhaler
RESCUE: Salbutamol 100 mcg prn
TREATMENT PERIOD: 52 weeks
CO‐INTERVENTIONS: ICS 50%, cromones 22% |
| Outcomes |
OUTCOMES: PEF, FEV1, Rescue use, asthma symptoms, Exacerbations, BHR, % days with no symptoms ,% nights with no asthma awakenings |
| Notes |
Exacerbations defined as worsening of asthma symptoms that required treatment in addition to the study drug and rescue SABA.
no details on symptom score. |
