| Methods |
STUDY DESIGN: Parallel group, 3 treatment arms; multicentre, 25 centres Norway, Sweden, Spain, Italy. 12 wks.
RANDOMISATION: Yes, method not given.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 38 described. 27 to asthma, 11 to adverse events.
COMPLIANCE: Not assessed/ reported.
CONFOUNDERS: Groups well balanced by characteristics. Excess withdrawals from SABA group, 10 subjects did not fully meet inclusion criteria.
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 397 Adults, M = 232 F = 179 Mean age 47 (RANGE 18 to 79)
BASELINE SEVERITY: mild ‐ moderate asthma.
INCLUSION : Diagnosis asthma by ATS criteria. Baseline FEV1 50‐80% predicted, >15% FEV1 reversibility to SABA.
EXCLUSION: none stated in paper. |
| Interventions |
LONG ACTING BETA AGONIST: Formoterol 6 mcg BD
SHORT ACTING BETA AGONIST: Terbutaline 500mcg QDS
PLACEBO: Placebo QDS
DEVICE: Dry powder device.
TREATMENT PERIOD: 12 weeks
RESCUE: Terbutaline 250 mcg via turbuhaler PRN
CO‐INTERVENTIONS: ICS 80%, cromones 5% (at stable dosages) |
| Outcomes |
OUTCOMES: FEV1, PEF, Rescue use, asthma symptom score, adverse events. asthma deterioration |
| Notes |
Symptom Score‐ breathlessness, chest tightness, wheezing, cough. Scale :0 ‐ 3. Asthma deterioration leading to withdrawal reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
