| Methods |
STUDY DESIGN: 2 way cross over, general practice setting, unspecified number practices in UK
RANDOMISATION: Yes, no method stated.
BLINDING: open, not blinded.
WITHDRAWALS/DROP OUTS: 26 pre‐randomization, 16 post randomisation (adverse events etc) 28 non compliant.
COMPLIANCE:. Assessed by diary card, 28 excluded for non compliance..
CONFOUNDERS:
QUALITY: Jadad 2. Cochrane B |
| Participants |
N = 128 ENROLLED/ 102 RANDOMISED, 58 completed, ADULT, M = 54 F = 48 Mean age: 39 (range 18 to 71)
BASELINE SEVERITY: Mild persistent asthma
INCLUSION : Adult asthmatics, requiring daily bronchodilator treatment < 800mcg SABA/day. Baseline FEV1 > 75% predicted, > 15% FEV1 reversibility to SABA. Minimum symptom score 1:4 in 4 of 7 days run in.
EXCLUSION: Serious uncontrolled diseases, URTI < 2 weeks, pregnancy, lactation, OS within 6 weeks, > 4 courses OS within 12 months. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Terbutaline 500 QDS
PLACEBO: none
DEVICE: SABA turbuhaler, LABA diskhaler.
TREATMENT PERIOD: 4 weeks
RESCUE: Salbutamol 100 mcg PRN
CO‐INTERVENTIONS: ICS < 400mcg /day 50%, cromones, theophyllines at constant dose |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, asthma symptom score, nights with asthma, patient assessment, adverse events |
| Notes |
Symptom Score‐ breathlessness, wheezing, cough. Scale :0 = none to3=symptoms most of day |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
