| Methods |
STUDY DESIGN: Parallel group. Multi centre, Canada. 12 week treatment period.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 21 described, 4 due to adverse events.
COMPLIANCE: Not assessed objectively.
CONFOUNDERS: Baseline characteristics similar for all groups.
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 300 screened, 228 ITT M = 128, F = 100 ADULT Mean age39 yrs (SD16)
BASELINE SEVERITY: Mild‐moderate persistent asthma.
INCLUSION : Requiring daily use of inhaled SABA for 6 months. Symptoms in 4/7 days run in. Baseline FEV1 50‐80% predicted, >15% reversibility to inhaled SABA
EXCLUSION: use of oral steroids, theophylline or ipratropium |
| Interventions |
LONG ACTING BETA AGONIST Salmeterol 50mcg BD
SHORT ACTING BETA AGONIST: Albuterol 180 mcg QDS
PLACEBO: Placebo BD
DEVICE: MDI
TREATMENT PERIOD: 12weeks
RESCUE: Short acting beta2 agonist‐ salbutamol 100 mcg inhalation PRN
CO‐INTERVENTIONS: ICS >70%, cromones, anti histamines, immunotherapy |
| Outcomes |
OUTCOMES: FEV1, FVC, FEV25‐75%, PEF, Rescue albuterol, asthma symptom score, night awakenings, asthma exacerbations, adverse events. |
| Notes |
Symptom Score‐ breathlessness, chest tightness, wheezing, cough
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) |
