Background: Hydrofluoroalkane-beclomethasone dipropionate AutohalerTM (HFA-BDP AH) is a breath-actuated chlorofluorocarbon (CFC)-free metered dose inhaler in which BDP is in a solution of HFA propellant. Budesonide TurbuhalerTM (BUD TH) is a breath-dependent dry powder inhaler. Objectives: To test the hypothesis that half the daily dose of HFA-BDP AH would provide an equivalent control of asthma symptoms to the BUD TH. Methods: This was an 8-week open study in patients with symptomatic moderate-to-severe asthma, previously on BUD 500–1,000 µg day–1, or an equivalent. After 5–14 days’ run-in, patients were randomized to HFA-BDP AH 800 µg day–1 or BUD TH 1,600 µg day–1. The intent-to-treat population consisted of 111 patients on HFA-BDP AH and 98 patients on BUD TH. Results: Mean change from baseline in PEF in the morning (AM PEF) at week 8 was 23.95 liters min–1 for HFA-BDP AH and 24.46 liters min–1 for BUD TH. A two-sided equivalence test using the 0.51 liter min–1 difference gave 95% confidence intervals within a defined equivalence interval of (–∞, 25 liters min–1) indicating that the mean change in AM PEF was equivalent for the two groups. There were no significant differences in the mean change from baseline in FEV1 or β-agonist use. Patients using HFA-BDP AH had a significantly greater mean change from baseline in the percentage of days free from shortness of breath (p = 0.05), chest tightness (p = 0.02) and nights without sleep disturbance (p = 0.04) at week 3, and wheeze (p = 0.01), shortness of breath (p = 0.02), chest tightness (p < 0.01) and daily asthma symptoms (p = 0.03) at week 8. The incidence, type and severity of adverse events were similar in each group. At week 8, the mean change from baseline in corrected urine cortisol/creatinine ratio in a subgroup of patients was –0.36 for HFA-BDP and –4.88 for BUD TH (p < 0.01). Conclusions: HFA-BDP 800 µg day–1 provided control of moderate-to-severe asthma with efficacy and safety at least similar to BUD TH 1,600 µg day–1.
Important differences exist between countries in Europe in home treatment of chronic respiratory disease. Comparative analysis should help achieve uniform standards and provide a basis for future research.
all specimens: psoriasiform changes were observed in the epidermis (hyperkeratosis and parakeratosis, and absence of granular layer). A superficial lymphocytic and eosinophilic infiltrate was found in the upper dermis. This infiltrate was prominent around the vessels. There were no pathological criteria suggesting cutaneous T-cell lymphoma. Mycological cultures from skin and nails were negative. Serum thyroid hormone levels were normal. Blood testing for arsenic was negative. Chest computed tomographic scan, upper gastrointestinal tract examination and endoscopy were normal. Howel-Evans syndrome, arsenicism, Bazex syndrome and eczema were therefore excluded. Local treatment with 10% urea, salicylic acid, caryolysin and oral retinoids gave no improvment. We finally stopped venlafaxine treatment and within 4-5 weeks the palm and sole hyperkeratosis slowly resolved without any other therapy. The nail changes were also dramatically improved. We then concluded that our patient had venlafaxine-induced palmoplantar keratoderma with subungual hyperkeratosis.Drugs are very rarely implicated in the pathogenesis of subungual hyperkeratosis: docetaxel 4 and clofazimine 5 have been reported as causative agents. Drug-induced palmoplantar keratoderma has also been reported only with a few drugs. Isolated case reports have implicated verapamil, 6 tegafur, 7 glucan 8 and lithium. 9,10
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