| Methods |
STUDY DESIGN: Parallel group. Multi centre, Europe‐ 62 centres . 52 week treatment period.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 60 described during treatment , mainly due to asthma and poor compliance.
COMPLIANCE: Recorded but no published.
CONFOUNDERS: Baseline characteristics similar for all groups.
QUALITY: Jadad 5. Cochrane A |
| Participants |
N = 796 screened, 667 randomised ( ITT) M = 332, F = 335 ADULT Mean age 49 yrs (range 18 to 81)
BASELINE SEVERITY: Moderate persistent asthma.
INCLUSION : Diagnosis of asthma with regular symptoms, symptoms score > 2 on 4/7 days run in, Baseline FEV1 > 50 predicted, > 15% reversibility to inhaled SABA
EXCLUSION: LRTI, hospitalization with asthma < 14 days, use of oral steroids > 20 mg /day, theophylline or ipratropium |
| Interventions |
LONG ACTING BETA AGONIST Salmeterol 50mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 200 mcg QDS
PLACEBO: Placebo BD
DEVICE: MDI
TREATMENT PERIOD: 12weeks
RESCUE: Short acting beta2 agonist‐ salbutamol 100 mcg inhalation PRN
CO‐INTERVENTIONS: ICS >61%, OS 15%, cromones. |
| Outcomes |
OUTCOMES: FEV1, FVC, FEV25‐75%, PEF, Rescue use, asthma symptom score, night awakenings, asthma exacerbations, adverse events. |
| Notes |
Symptom Score‐ 0 = none to 5 = severe. Exacerbations asthma defined as worsening of asthma symptoms recorded as an AE requiring change in therapy other than inhaled SABA |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
