| Methods |
STUDY DESIGN: Parallel group, multicentre, 27 in Italy. 12 weeks initially, with 12 month follow on.
RANDOMISATION: Yes, used PACT computer code, allocation blocks of 2.
BLINDING: open label, not blinded.
WITHDRAWALS/DROP OUTS: 27 withdrawals detailed in 3mths, 1 in follow up period
COMPLIANCE: Not assessed
CONFOUNDERS: Groups well balanced by characteristics
QUALITY: Jadad 3. Cochrane A |
| Participants |
N = 252 screened RANDOMISED/COMPLETED = 234 ITT, adult, M = 116 F = 118 Mean age: 45 (range 18 to 81)
BASELINE SEVERITY: Mild to moderate asthma
INCLUSION : Baseline FEV1 50 to 80% predicted, >15% FEV1 reversibility to SABA.
EXCLUSION: none specified. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 200 mcg QDS
PLACEBO: none
DEVICE: MDI
TREATMENT PERIOD: 12 weeks initial, 12 months follow on.
RESCUE Salbutamol prn
CO‐INTERVENTIONS: ICS 10%, OS < 20mg/day 4% |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, Rescue use, asthma symptom score, adverse events. Exacerbations. Efficacy score‐patient and investigator rated. Asthma QOL score |
| Notes |
Exacerbations‐ not defined.
Symptom Score‐ Night‐time 0‐4 (none ‐ so severe that no sleep possible).
Daytime Symptom Score‐ 0 = none to 5 = severe.
LWAQ for QOL measure (Italian version) |
| 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) |
