General Internal Medicine

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Browsing General Internal Medicine by Author "Bardin, P. G."

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    Inhaled beta-stimulants - a study of high-dose v. conventional-dose treatment in asthmatic outpatients
    (Health & Medical Publishing Group, 1991) Bardin, P. G.; Joubert, J. R.
    A randomised double-blind controlled trial was conducted in order to compare pulmonary function and protective effects of salbutamol 200 μg v. 1000 μg by inhalation. Twenty-three known asthmatics took part in the study for a period of 12 weeks. Pulmonary function tests were performed at home (peak expiratory flow-rate (PEFR)) and in the laboratory (vital capacity (VC), forced expiratory volume in 1 second (FEV1) and PEFR) before and after treatment. Bronchial responsiveness was measured as the provocative dose of histamine that caused a decrease of 30% of the area under the flow-volume curve (AFVE30) 90 minutes after pre-treatment with the study medication. The 20 patients (10 per treatment group) who completed the study were comparable at base-line in respect of physiological and pulmonary function measurements. Median PEFR, FVC and FVC1 did not differ between the treatment groups for the duration of study. Histamine challenge testing demonstrated a significant decrease in protection that was only seen after 8 weeks of treatment in the high-dose group (P < 0,05). Changes in pulse rate, blood pressure as well as side-effects were similar in the two groups. Thus treatment with higher doses of β-stimulants in outpatients had no demonstrable advantage. A significant impairment of the ability to protect against histamine-induced bronchoconstriction was shown; this may relate to β-receptor down-regulation and hence the development of tachyphylaxis.
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    Therapeutic equivalence study of two formulations (innovator v. generic) of beclomethasone dipropionate in adult asthmatic patients
    (Health & Medical Publishing Group, 2001) Nell, H.; Louw, C. M.; Cyster, H.; Williams, Z.; Bardin, P. G.; Joubert, J. R.
    Objective. To study the therapeutic equivalence of two formulations (innovator v. generic) of beclomethasone dipropionate (BDP) 400 μg twice daily administered per metered dose inhaler (MDI), in adults with moderate to severe asthma. Methods. A double-blind randomised parallel-group trial was performed with a 2-week run-in and an 8-week treatment period. Thirty-six symptomatic adult asthmatics on a mean daily dose of 750 μg inhaled corticosteroids during run-in, a mean forced expiratory volume in 1 second (FEV1) of 70% predicted normal and a mean histamine concentration provoking a 20% reduction in FEV1 (histamine PC20) of 0.11 mg/l were randomised to one of the two treatment groups. Primary variables were morning peak expiratory flow (mPEF), FEV1 and histamine PC20. Secondary variables were β2-agonist use, symptom score and nocturnal awakening. The Schuirmann two one-sided tests procedure was used for the statistical analysis. Ninety-five per cent confidence intervals (CIs) were calculated for the differences in means. Results. The mean differences end of treatment to baseline for the two formulations (Becotide and Beclate) respectively were: mPEF 5.6 l/min (CI-16.4 - 27.6) and -22.3 l/min (CI-35.6 - -9); FEV1 -2.9% (CI -11 - 5.2) and 0.2% (CI-4.8 - 5.2); Histamine PC20 -0.04 mg/ml (CI -0.15-0.06) and 0.02 mg/ml (CI -0.37 - 0.4). Changes in clinical variables were not conclusive. The mean differences with CIs for primary variables were contained within the limits set for equivalence. The sample size was sufficient to differentiate the groups for mPEF, but this was not of clinical significance. Conclusion. After 8 weeks of treatment the two formulations of BDP, delivered by MDI through a large-volume spacer, were therapeutically equivalent in moderate-to-severe asthmatic adults.