| Methods |
STUDY DESIGN: Three treatment parallel group, multicentre (11) study in USA, 12 wks
RANDOMISATION: Yes, method not given.
BLINDING:Double blind, double dummy, with 2 matching inhalers.
WITHDRAWALS:42/322 , by groups ‐ 15 in salmeterol , 16 in albuterol, 11in placebo
CONFOUNDERS: differential rates of ICS and cromone use in regular and prn group, use of theophyllines in run in period
QUALITY: Jadad = 4, Cochrane B |
| Participants |
N = 322 Albuterol = 108, placebo =108, salmeterol = 106
AGE‐ means ‐albuterol 31(14), placebo 28(12), salmeterol 29(12)
BASELINE SEVERITY: Chronic symptomatic asthma.
INCLUSION: Diagnosis asthma by ATS criteria, requiring daily drug treatment for > 6 months. Baseline FEV1 50‐70% predicted, >15% FEV1 reversibility to SABA.
EXCLUSION: Smokers |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 42 mcg BD
SHORT ACTING BETA AGONIST: Albuterol 180mcg QDS PLACEBO:placebo QDS
DEVICE: MDI
PERIOD:12 weeks
RESCUE:albuterol 90mcg prn
CO‐INTERVENTIONS:
ICS ‐ used by 20% on placebo , 24% on albuterol, 21% on salmeterol
ORAL STEROIDS ‐ not at randomisation
CROMONES‐used by 9% on placebo , 6% on albuterol, 10% on salmeterol
THEOPHYLIINES‐ used only during run in by 46% on placebo , 50% on albuterol, 43% on salmeterol
ORAL BETA AGONISTS ‐ not permitted |
| Outcomes |
OUTCOMES: FEV1, FVC, FEV25‐75%, PEF, Rescue use, asthma symptom score, symptom free days & nights, adverse events . |
| Notes |
Exacerbations defined as worsening of asthma symptoms that required treatment in addition to the study drug and rescue SABA.
Symtom Score‐ composite based on individual scores for breathlessness, chest tightness, wheezing, cough. Scale : 0 = none to 5 = severe, activities cancelled. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
