| Methods |
RCT: parallel group design
Blinding: none. |
| Participants |
ICS: 40 at entry, 40 at completion, (100% completed)
SCG: 39 at entry,39 at completion, (100% completed)
Mean age: 34.6
Age range: 20‐52
Gender: 64% male.
Race/ethnicity: not reported.
Setting: not reported.
Asthma severity: mild and moderate persistent (based on baseline FEV1>75%).
Inclusion: none?
Exclusion: none? |
| Interventions |
After a 2 wk run‐in period, subjects were randomized to sodium cromoglycate, nedocromil sodium, beclomethasone dipropionate, or placebo. Subjects could receive B2‐agonists or ipratropium bromide as rescue medication; if worsening of symptoms occurred, an oral corticosteroid was permitted.
Duration: 12 weeks.
Dose: 500 mcg (ICS); 0.01 mg (SCG).
Daily dose: 1500 mcg (ICS) Low dose; 0.04 mg (SCG).
Doses/day: 3 (ICS); 4 (SCG).
Cumulative dose: 126000 mcg (ICS); 3.36 mg (SCG).
Delivery device: MDI. |
| Outcomes |
FEV1, PD20, inhaled bronchodilator dose, symptom scores. |
| Notes |
Jadad Quality Score: 1
Possible performance bias (lack of blinding may influence physician care) and detection bias (lack of blinding may influence physician's lung function measurements and patients' assessment of symptoms, effort on lung function tests, etc). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |