| Methods |
STUDY DESIGN: Crossover, 3 way design. 4 week per treatment. Single centre UK.
RANDOMISATION: Yes, computer generated random code.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 5 described during treatment , 1 due lack efficacy,3 FTA.
COMPLIANCE: Assessed by counting unused blisters, >80%.
CONFOUNDERS: no washout period at cross over, used second 2 week data only..
QUALITY: Jadad 5. Cochrane A |
| Participants |
N = 52 screened, 45 randomised ( ITT) CHILDREN. M = 31 F = 14 Mean age 9 yrs (sd 2.8)
BASELINE SEVERITY: Symptomatic asthma on medium dose ICS.
INCLUSION : Asthma requiring > 400mcg ICS . > 15% reversibility on PEF or FEV1 to inhaled SABA
EXCLUSION: URTI/ use of OS/ hospitalization with asthma < 4 weeks, theophylline or ipratropium use. |
| Interventions |
LONG ACTING BETA AGONIST Salmeterol 50/ 100 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 200 mcg QDS
PLACEBO: Placebo BD
DEVICE: Diskhaler
TREATMENT PERIOD: 4 weeks
RESCUE: Short acting beta2 agonist‐ salbutamol 200 mcg inhalation up to 6 times daily
CO‐INTERVENTIONS: All on ICS >400 mcg. |
| Outcomes |
OUTCOMES: FEV1, FVC, FEV 25‐75%, PEF, Rescue use, asthma symptom score, symptom free days, adverse events , BHR (in subgroup). |
| Notes |
No description of asthma score. |
| 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) |
