| Methods |
STUDY DESIGN: Parallel group, multicentre, 15 centres Canada.
RANDOMISATION: Yes, no method stated. 24 wks.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 54 described.
COMPLIANCE: Not assessed/ reported.
CONFOUNDERS: Groups well balanced by characteristics.
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 374 RECRUITED, 271 RANDOMISED. Adults, M = 116 F = 155 Mean age 36 (SD 13)
BASELINE SEVERITY: moderate to severe asthma.
INCLUSION : Diagnosis asthma by ATS criteria. > 15% FEV1 reversibility to SABA. Using ICS 400 to 1200 mcg for > 1mth. PC20 methacholine < 8mg/ml
EXCLUSION: URTI/ Change in asthma medication/ exacerbation asthma within 2 months. Smoking. |
| Interventions |
LONG ACTING BETA AGONIST: Formoterol 12 mcg BD
SHORT ACTING BETA AGONIST: Albuterol 200mcg QDS
PLACEBO: Placebo QDS
DEVICE: Dry powder device.
TEATMENT PERIOD: 24 weeks
RESCUE:Albuterol 100 mcg PRN
CO‐INTERVENTIONS: ALL ON ICS . Theophylinne, Ipratroprium, Cromones, antihistamines‐ at fixed doses. |
| Outcomes |
OUTCOMES: FEV1, FVC, FEV25‐75%, PEF, Rescue use, asthma symptom score, exacerbations asthma, BHR, adverse events . |
| Notes |
Symptom Score‐ 0 = best to 4 = worst. Exacerbation defined as that requiring increase in corticosteroid cover. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
