Skoner 2011.
Methods | Design: phase III, multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: Merck & Co, Inc |
|
Participants | Setting: multi‐centres in the USA Eligible: not reported Randomly assigned: 48 (mometasone 100 μg QD); 44 (mometasone 100 μg BID); 50 (mometasone 200 μg QD); 45 (placebo) Analysed: 48 (mometasone 100 μg QD); 44 (mometasone 100 μg BID); 50 (mometasone 200 μg QD); 45 (placebo) Gender (male): 70.1% Age, years, mean: 6.5 Inclusion criteria: children 4–9 years of age with history of asthma ≥ 6 months; FEV1 ≥ 75% predicted value at both screening visit and baseline visit (for children 4–5 years of age, FEV1 ≥ 75% predicted value for any single measurement, or average morning PEF ≥ 75% predicted normal at screening or baseline); normal height (5th–95th percentiles on standard growth charts) upon measurement with a stadiometer; skeletal age within 2 years of chronological age; morning plasma cortisol levels ≥ 5 μg/dL; no greater than stage 1 in the Tanner Classification of Sex Maturity Exclusion criteria: increase or decrease in FEV1 ≥ 20% between screening and baseline visits; ≥ 12 puffs per day of albuterol on any 2 consecutive days between screening and baseline visits; inpatient hospitalisation for asthma control within the previous 3 months; ventilator support for respiratory failure secondary to asthma within the previous 5 years; hospital admission for management of airway obstruction on 2 or more occasions over the past 6 months; asthma requiring daily use of nebulised short‐acting β2‐agonist or any use of long‐acting β2‐agonists; asthma requiring long‐term use of inhaled or systemic corticosteroids; inability to use a DPI device or a peak flow meter; history or evidence of abnormal growth; presence of any disease or condition with the potential to substantially affect growth or requiring concomitant corticosteroid therapy; evidence of gross malnutrition; history of any disease that could have interfered with study evaluations; upper or lower respiratory tract infection within 2 weeks of screening and baseline visits Previous regular use of ICS: not allowed |
|
Interventions | Test group:
Control group: matching placebo Treatment was given via DPI for 52 weeks |
|
Outcomes |
Height was measured using a Harpenden stadiometer, and a mean of 3 values was recorded. When possible, the same study personnel performed height measurements for a given participant throughout the study, at approximately the same time of day for each visit |
|
Notes | Treatment compliance was assessed by diary. Compliance rate ranged from 75%‐83% in the mometasone groups and 89% in the placebo group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details provided |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Use of matching placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Use of matching placebo |
Incomplete outcome data (attrition bias) All outcomes | High risk | Withdrawal rate was 52/187 (27.8%) |
Selective reporting (reporting bias) | Low risk | Study protocol is not available, but published reports include all expected outcomes, including those that were prespecified |
Other bias | Low risk | Study appears to be free of other sources of bias |