Choudhury AB, Dawson CM, Kilvington HE, et al. Withdrawal of inhaled corticosteroids in people with COPD in primary care: A randomised controlled trial. Respiratory Research 2007;8(93).
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/18162137
Full text article: https://respiratory-research.biomedcentral.com/articles/10.1186/1465-9921-8-93
| Methods | Study design: Randomized double-blind, placebo-controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 260 randomized, 126 completed
· Active deprescribing group: 132 randomized, 54 completed · Control group: 128 randomized, 72 completed Age: 67.6 ± 8.9 years Sex: 124 female, 136 male Participants with dementia: No Inclusion criteria: · Aged 40 years and over · History of smoking · Prescribed inhaled corticosteroids for a minimum of six months Exclusion criteria: · Long-term oral corticosteroids · Not taking their prescribed inhaled corticosteroids for at least four days a week · Other chronic active lung disease · Lung cancer Other: Patients had smoked an average of 39 pack-years Country: England Setting: community – 31 general practices in east London and Essex to take part |
| Interventions | Medicine: Inhaled corticosteroids – fluticasone propionate 500 mcg, one puff twice-daily using an accuhalerdevice
Withdrawal schedule: Abrupt Comparator: Placebo compared to continued medicine |
| Outcomes | COPD exacerbation frequency
Time to first exacerbation Reported symptoms Peak expiratory flow rate Reliever inhaler use Return to usual steroid inhaler Lung function Health-related quality of life – St George’s respiratory questionnaire – EuroQol 5-D total and visual analog scale Adverse effects |
| Dates | Dates: Not described
Follow-up duration: One year |
| Funding sources | The British Lung Foundation and Newham National Health Service Trust Research and Development funded the study. GlaxoSmithKline provided the study inhalers free of charge but was not involved in study design, data collection, analysis, or interpretation of results. |
| Notes | Participants had used an inhaled corticosteroid for a median of eight years before study recruitment.
Additional information sought, but not received. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | “Patients were allocated with minimization to intervention and control using the program MINIM v1.3.” |
| Allocation concealment (selection bias) | Low risk | “Inhalers were given an alphanumeric code to conceal allocation.” |
| Blinding of participants and personnel (performance bias) | Low risk | Placebo described in limited detail.
“were allocated to fluticasone 500mcg one puff twice-dailyusing an accuhalerdevice or identical placebo.” “Study nurses and regular clinicians were blind to allocation throughout the study.” |
| Blinding of outcome assessment (detection bias) | Low risk | As above. |
| Incomplete outcome data (attrition bias) | Unclear risk | Intention-to-treat analysis.
No mention was made of incomplete data. All study patients were accounted for, but 29 withdrew consent, were lost to follow-up or “Other.” It is impossible to judge whether the withdrawal was related to the intervention. The number of patients is around 10% of the study group. |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported:
· Primary outcome was COPD exacerbation frequency – YES Secondary outcomes were: · Time to first exacerbation YES · Reported symptoms – YES · Peak expiratory flow rate and reliever inhaler use (from diary cards), and lung function and health-related quality of life (at follow-up visits) – YES |
| Other bias | Low risk | Conflicts reported and appeared to be irrelevant to this study. |
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