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. 2013 Apr 30;2013(4):CD007313. doi: 10.1002/14651858.CD007313.pub3

Sovani 2008.

Methods Randomised, open‐label, parallel group study over a 6‐month period.
Participants Population:  71 adults aged 18‐70 years with asthma, on at least 400‐1000 µg/day ICS who demonstrated poor compliance and were poorly controlled.
Inclusion Criteria: Aged 18‐70 years. Previous treatment with ICS (400‐1000 µg/day beclomethasone equivalent) who demonstrated poor compliance by collecting less than 70% of expected ICS prescriptions in the previous year. Poor control demonstrated by at least two prescriptions of prednisolone or 10 canisters of reliever inhaler in previous year.  At least four puffs of reliever for at least 4 days per week over past 4 weeks. Patients with a smoking history of over 20 pack‐years or exacerbation requiring oral steroids in the past 4 weeks were not included.
Baseline characteristics: Mean age:  36 years. FEV1 85% predicted. Mean ICS dose at enrolment 590 µg/day, but only 278 µg/day was being taken!  Hospital admission for asthma in the past year: unknown. Course of oral steroids for asthma in past year: mean of one course per year (SD 1).
Interventions

  1. Budesonide/formoterol 200/6 µg one inhalation twice daily [400 µgbudesonide/day], as maintenance and reliever.

  2. Budesonide 200 µg [400 µgbudesonide/day], one inhalation twice daily via Turbohaler and usual reliever.
Outcomes Primary outcome:

  • Dose of inhaled budesonide.  


Secondary outcomes

  • FEV1

  • Mini AQLQ

  • ACQ scores

  • Oral corticosteroid use

  • Visits to GP for asthma‐related problems.
Notes Supported by an unconditional grant from AstraZeneca
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk An independent pharmacist used computer‐generated random numbers to randomise each participant to one of two groups.
Blinding (performance bias and detection bias) 
 All outcomes High risk Open‐label study
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 55/71 (77%) completed the study and there were more withdrawals in the control arm: 13 compared to 3 in active arm (all 3 reported difficulty using the inhaler)
Selective reporting (reporting bias) Unclear risk The primary outcome for this study was compliance and data were not presented on exacerbations