Bernstein 1999.
Methods | Setting: multicentre study, USA Length of intervention period: 12 weeks Randomisation: yes, using a computer‐generated code Allocation concealment: method was stated Design: Masking: double‐blind, double‐dummy Excluded: Stated Withdrawals: Stated Baseline characteristics: Comparable Jadad score: 4 | |
Participants | 365 children and adults 222 F 143 M
Age range: 12 to 74 years
Inclusion criteria: Patients with a history of asthma for at least 6 months,
Using an inhaled glucocorticoid daily for at least 30 days
Patients must have a stable of regimen of TAA, BDP or FP
None smokers or stopping in the last 6 months Any medication that interacts with the inhaled corticosteroids was not allowed Increase in the FEV1 >12% within 30 min after two puffs of albuterol
90>FEV1>60 of predicted normal value Exclusion criteria: Pre‐menarche Pregnancy Lactation Immunotherapy unless on a stable maintenance Treatment with oral corticosteroids for >14 days, in the last 6 months Need of ventilator support in the previous 5 year Hospitalization for asthma in the previous 3 months Requirement of >12 puffs a day of short acting B2‐agonist on 2 consecutive days. |
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Interventions | 1‐MF 100 mcg bid (200 mcg/day)
2‐MF 200 mcg bid (400 mcg/day)
3‐MF 400 mcg bid (800 mcg/day)
4‐BDP 168 mcg bid (336 mcg/day)
5‐Placebo Delivery device: MDI |
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Outcomes | FEV1 (%), FEV1 (%) with FEV1<75% predicted, FEV1 (%) with FEV1 >75% predicted, FVC (%), FEF25‐75%, AM PEFR (%), PM PEFR (%), wheezing score, difficulty breathing scores, cough score, B2‐ agonist use, number of nocturnal awakenings, response to therapy scores | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |