Skip to main content
. 2005 Jan 24;2005(1):CD002738. doi: 10.1002/14651858.CD002738.pub2

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.
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
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