| Methods |
Setting: Multi‐center
Length of intervention period:12 to 16 weeks
Randomisation: yes, using a computer‐generated schedule
Allocation concealment: yes
Design: parallel group
Masking: double blind
Excluded: stated
Withdrawals: stated
Baseline characteristics: comparable
Jadad score: 4 |
| Participants |
642 patients, age >15
Inclusion criteria: None smokers
A history of intermittent or persistent asthma for at least one year
On inhaled corticosteroids for at least 6 weeks before the pre study visit
Exclusion criteria: Respiratory disorders other than asthma Upper respiratory infection within the 3 wk before the pre study visit Pregnancy |
| Interventions |
1‐ montelukast 10 mg /day + BDP 200 mcg x 2/day(16 wk)
2‐ placebo tab + BDP 200mcg x 2/day (16 wk)
3‐ montelukast 10 mg/day + inhaled placebo (12 wk)
4‐ placebo tab/day + inhaled placebo (12 wk) |
| Outcomes |
FEV1
Morning PEFR Evening PEFR Daytime symptoms score B‐agonist use |
| Notes |
Missing data has been requested from the author |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
