| Methods |
STUDY DESIGN: Parallel group, multicentre, 14 centres Canada, 12 weeks.
RANDOMISATION: Yes, no method stated.
BLINDING: Double blind, double dummy, matching inhalers.
WITHDRAWALS/DROP OUTS: 41 described after randomization.
COMPLIANCE: > 70% reported for all but 7 subjects.
CONFOUNDERS:
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 451 RANDOMISED. Adults, M = 262 F = 189 Mean age 31 (sd 14)
BASELINE SEVERITY: mild ‐ moderate asthma.
INCLUSION : Diagnosis asthma by ATS criteria. Baseline FEV1 50‐80% predicted, >15% FEV1 reversibility to SABA. Requiring daily drug treatment for > 6 mths.
EXCLUSION: smoking. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Albuterol 180 mcg QDS
PLACEBO: placebo QDS
DEVICE: MDI & dry powder device.
TREATMENT PERIOD: 12 weeks
RESCUE: Albuterol 100 mcg PRN
CO‐INTERVENTIONS: ICS 55 to 70 % . Cromones 7 to 12 % |
| Outcomes |
OUTCOMES: FEV1, FVC, FEV 25‐75%, PEF, Rescue use, asthma symptom score, symptom free days & nights, adverse events, exacerbations. |
| Notes |
Symptom Score‐ breathlessness, chest tightness, wheezing, cough. Scale : 0 to 3.
Exacerbations defined as worsening of asthma symptoms that required treatment in addition to the study drug and rescue SABA. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
