| Methods |
STUDY DESIGN: Parallel group
LOCATION, NUMBER OF CENTRES: 36 centres in USA.
DURATION OF STUDY:
CONCEALMENT OF ALLOCATION: COCHRANE QUALITY SCORE: B
DESCRIBED AS RANDOMISED: Yes
DESCRIBED AS DOUBLE BLIND: Yes
METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: Not reported
METHOD OF BLINDING WELL DESCRIBED/APPROPRIATE: Yes (double‐dummy)
DESCRIPTION OF WITHDRAWALS/DROPOUTS: 59/449 (lack of efficacy: 11; adverse event: 8; failure to return: 7; other: 33).
JADAD SCORE (5‐1): 4.
TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): Non‐ITT for efficacy outcomes; ITT for safety outcomes.
COMPLIANCE: Not assessed.
CONFOUNDERS: Baseline characteristics not adequately presented. |
| Participants |
N SCREENED: 756
N RANDOMISED: 449
N COMPLETED: 390
M= 61% F= 39% MEAN AGE: 8 years (range 4‐11)
BASELINE DETAILS: Caucasian 78%, Black 12%, Mean PEFR 80% predicted; mean FEV1 70% predicted; 65% report nocturnal symptoms; 80% report that symptoms interfere with activities one day per week
SEVERITY OF ASTHMA: persistent
INCLUSION CRITERIA: PEFR (4‐5 years)/FEV1 (6‐11 years 45‐80% predicted)
EXCLUSION: Not reported. |
| Interventions |
1. Salmeterol 25mcg BID
2. Salmeterol 50mcg BID
3. Placebo
DELIVERY: DPI
TREATMENT PERIOD: 12 weeks (no run‐in described)
RESCUE: SABA prn
CO‐INTERVENTIONS PERMITTED: ICS, cromolyn, nedocromil
CO‐INTERVENTIONS: cromolyn/nedocromil: 25%
% on ICS: approx 50% |
| Outcomes |
OUTCOMES MEASURED: Serial PEFR % predicted; PEFR AUC; serial FEV1 % predicted; FEV1 AUC; change in post‐dose PEFR % predicted; change in post‐dose FEV1 % predicted; mean change in am PEFR; change in daily asthma symptom score; change in % nights with no awakenings; withdrawals; adverse events;
FOLLOW‐UP ASSESSMENT POINTS: Day 1, weeks 6 & 12
OUTCOMES INCLUDED IN ANALYSES: Withdrawals; adverse events
SUB‐GROUPS INDENTIFIED: <9 years versus >9 years. |
| Notes |
Symptom score 1= no symptoms at all, 2= symptoms with little or no discomfort, unrestricted activity, 3=symptoms occurred, were sometimes annoying or affected routine activity, 4= symptoms occurring even at rest, were annoying or affected activity |
