| Methods |
RCT: parallel group design.
Blinding: none. |
| Participants |
ICS: 10 at entry, 10 at completion (100% completed).
SCG: 9 at entry, 9 at completion (100% completed).
Mean age: 28
Age range: 16‐50
Gender: 63% male.
Race/ethnicity: not reported.
Setting: Tokyo, Japan; clinical setting not reported.
Asthma severity: mild or moderate persistent.
Inclusion: 1) asthma diagnosis based on chest tightness, wheezing, coughing, or shortness of breath and reversible airflow obstruction; 2) 2 or more positive skin tests and presence of aeroallergen‐specific IgE; 3) no inhaled or oral corticosteroids or any other anti‐inflammatory drugs in previous 2 mos.
Exclusion:
1) smoking; 2) FEV1 <50% pred; 3) upper/lower respiratory tract disease in previous 2 weeks. |
| Interventions |
Patients were randomly allocated to receive either ketotifen, DSCG, or BDP for 12 weeks of treatment. B2‐agonists were used as necessary.
Duration: 12 weeks.
Dose: 100 mcg (ICS); 2 mg (SCG).
Daily dose: 400 mcg (ICS) Low dose; 8 mg (SCG).
Doses/day: 4
Cumulative dose: 33600 mcg (ICS); 672 mg (SCG).
Delivery device: not reported |
| Outcomes |
(change in) FEV1% pred, (change in) PEF, *symptom score, cell counts (eosinophils, mast cells, and T cells). |
| Notes |
Jadad Quality Score: 2
Possible selection bias (PEF and FEV1 baseline measurements higher in BDP group) and performance/detection bias (open label trial). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
