| Methods |
STUDY DESIGN: Parallel group, 3 treatment arms; multicentre, 28 centres Scaninavia. 12 wks.
RANDOMISATION: Yes, computer generated random order, balanced blocks..
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 32 described, due to asthma.
COMPLIANCE: Not assessed/ reported.
CONFOUNDERS: Groups well balanced by characteristics.
QUALITY: Jadad 5. Cochrane A |
| Participants |
N = 343 Adults, M = 164 F = 179 Mean age 48 (RANGE 18 to 82)
BASELINE SEVERITY: moderate stable asthma.
INCLUSION : Diagnosis asthma by ATS criteria. Baseline FEV1 40 to 80% predicted, >15% FEV1 reversibility to SABA.
EXCLUSION: none stated in paper. |
| Interventions |
LONG ACTING BETA AGONIST: Formoterol 12 mcg BD
SHORT ACTING BETA AGONIST: Terbutaline 500mcg QDS
PLACEBO: Placebo QDS
DEVICE: Dry powder device‐ turbuhaler.
TREATMENT PERIOD: 12 weeks
RESCUE: Terbutaline 250 mcg via turbuhaler PRN
CO‐INTERVENTIONS: ICS 89%, cromones 2% ‐ stable doses OS 2 subjects |
| Outcomes |
OUTCOMES: FEV1, PEF, Rescue use, asthma symptom score, adverse events |
| Notes |
Symptom Score‐ breathlessness, chest tightness, wheezing, cough. Scale :0 ‐ 3 |
| 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) |
