| Methods |
STUDY DESIGN: Parallel group. Multi centre, 26 in USA. 12 week treatment period.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, double dummy, placebo controlled. Matching capsules and devices.
WITHDRAWALS/DROP OUTS: 83described, 35 due to adverse events.
COMPLIANCE: Assessed by counting capsules and weighing canisters, >80% in all gouprs.
CONFOUNDERS: Baseline characteristics similar for all groups.
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 541 randomised, 535 ITT M = 224, F = 317 ADULT Mean age 5.5 yrs (SD14.6)
BASELINE SEVERITY: Mild‐moderate persistent asthma.
INCLUSION : Diagnosis of asthma, requiring daily use of inhaled SABA. Baseline FEV1 40 to 80% predicted, > 15% reversibility to inhaled SABA
EXCLUSION: URTI, hospitalization/asthma exacerbation < 4 weeks, serious illness. |
| Interventions |
LONG ACTING BETA AGONIST: Formoterol 12/ 24 mcg BD
SHORT ACTING BETA AGONIST: Albuterol 180 mcg QDS
PLACEBO: Placebo QDS
DEVICE: LABA Aerolizer DP device & SABA MDI
TREATMENT PERIOD: 12weeks
RESCUE: Short acting beta2 agonist‐ albuterol 90 mcg inhalation PRN
CO‐INTERVENTIONS: ICS 51%, Slow release theophylline 17%. |
| Outcomes |
OUTCOMES: FEV1, FVC, FEV 25 to 75%, PEF, Rescue albuterol, asthma symptom score, asthma exacerbations, adverse events. |
| Notes |
Symptom Score‐ breathlessness, chest tightness, wheezing, cough; scaled 0‐4. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
