Distribution of therapeutic response in asthma control.
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Acetates↗
Biomedical subjects
G L Braunstein
Publications and source records attributed to G L Braunstein.
Achieving guideline-based asthma control: does the patient benefit?
Asthma management guidelines define asthma control, but the outcome criteria used do not include the patient's own assessment of their health. The objective of the present study was to determine the association between the achievement of asthma control, as defined by the Global Initiative for Asthma (GINA) guidelines, and patient-assessed asthma-related quality of life (QOL), particularly whether maximal or near-maximal QOL scores were attainable. Clinical data from three studies that compared salmeterol/fluticasone propionate combination therapy (SFC) with other treatments in patients with persistent asthma were retrospectively analysed. Achievement of asthma control was determined over an 8-week period in each study according to six parameters derived from the GINA guideline treatment goals. Asthma Quality of Life Questionnaire (AQLQ) scores (a 7-point scale, where 1=severe impairment and 7=no impairment) were analysed by treatment group for well-controlled and not well-controlled patients. The analysis showed that, across a range of severities, well-controlled asthma patients had consistently higher AQLQ scores at endpoint and larger AQLQ improvements from baseline, than patients who were not well controlled. For many well-controlled patients, endpoint scores approached 7, indicating little or no impact of asthma on their QOL. However, AQLQ scores of not well-controlled patients also improved substantially in some treatment groups, particularly the SFC group. These results suggest a relationship between the achievement of guideline-based asthma control and improvements in quality of life to levels where there is little or no impact of asthma on quality of life. Guideline-based asthma control is therefore beneficial to the patient and should be tested in prospective studies.
Albuterol↗
Is overall asthma control being achieved? A hypothesis-generating study.
The efficacy of asthma therapy is traditionally measured using single end-points. In contrast, the aim of therapy is to achieve overall control, defined by management guidelines as achieving a number of treatment goals. These goals reflect expert opinion, rather than being evidence based. The objective of this study was to determine whether guideline-defined asthma control is achievable. Eight studies of salmeterol/fluticasone propionate combination therapy were analysed using three asthma control measures of varying stringency, derived from the guideline goals. For each measure, only patients meeting all goals were classified as controlled. The analysis demonstrated that asthma control, as defined by management guidelines, can be achieved. For a given therapy, similar proportions of patients achieved control irrespective of disease severity, suggesting that outcome expectations should not be reduced for patients with more severe disease. Substantially more patients achieved the target values for individual goals than achieved overall control, indicating that reliance on individual end-points is likely to result in significant overestimation of true control. The findings of this hypothesis-generating study should be prospectively tested. Future research will include a randomized controlled study designed to assess the proportion of patients able to achieve overall control of asthma when treatment is titrated appropriately.
Albuterol↗
Compliance with nedocromil sodium and a nedocromil sodium/salbutamol combination. Compliance Working Group.
Nonadherence to prescribed preventive medication is common in asthma. We wanted to assess whether the combination of a beta 2-bronchodilator with an anti-inflammatory treatment in the same metered-dose inhaler (MDI) with a regular dosing schedule might improve compliance. A double-blind study was used to compare use (two actuations four times daily for 12 weeks) of 2 mg nedocromil sodium (n = 101) with a combination of 2 mg nedocromil sodium and 100 micrograms salbutamol (n = 100) in mild-to-moderate asthma patients (mean age 42 +/- 14 yrs; 98 males and 103 females). Compliance was measured using the electronic Nebulizer Chronolog (NC) device, change in MDI canister weight, patient questionnaire and physician assessment. The mean +/- SD number of actuations per day for nedocromil sodium and the combination during the primary period of assessment (Weeks 11-12) was 4.2 +/- 2.6 and 4.6 +/- 2.5 (NC), 5.3 +/- 2.1 and 5.3 +/- 2.0 (canister weight), and 7.5 +/- 1.3 and 7.4 +/- 1.3 (questionnaire), respectively. Physician assessment rated compliance as "good" to "excellent". The first and final days of the period were not used in the NC analysis to exclude part-days of treatment and drug-dumping (repeated actuations without inhalation), and may account for the difference between NC and canister weight results. The mean number of two-actuation doses per day determined from the NC was 2.1 +/- 1.3 for nedocromil sodium and 2.4 +/- 2.1 for the combination. Thirty five percent (nedocromil sodium) and 34% (combination) of the patients were compliant (6-10 actuations per day for > or = 60% of the days). We conclude that compliance is poor in asthma, electronic recording revealed the dumping phenomenon and, in this study, the combination of an inhaled beta 2-bronchodilator with a preventive treatment did not improve compliance over a three month period in patients with mild-to-moderate asthma.
Administration, Inhalation↗
[Anti-inflammatory effects of cromones in asthma].
The cromone family comprises sodium cromoglycate and the more recently developed nedocromil sodium. Nedocromil sodium prevents the bronchial obstruction induced by a variety of stimuli, including antigen. When given before antigen inhalation, nedocromil sodium prevents the early and late reaction and the increase in bronchial hyperresponsiveness. It is still effective in preventing the late phase when given after antigen exposure. These effects may result from the action of nedocromil sodium on inflammatory cells observed in vitro, particularly mast cells and eosinophils. When inhaled regularly, nedocromil sodium improves symptoms, especially in moderate asthma, decreases bronchial obstruction and reduces bronchial hyperreactivity. Bronchial biopsy studies have shown a decrease in activated eosinophils during prolonged nedocromil sodium treatment, suggesting that the clinical benefit results from an antiinflammatory effect of the drug. More recently, it has been suggested that nedocromil sodium may act on membrane chloride channel involved in activation of many cell types. In vitro data have shown a decrease in IgE production by isolated mononuclear cells, suggesting new therapeutic potential to be studied clinically.
Animals↗
[Comparative study of the acceptability of Tilade Syncroner and Tilade Standard by mildly asthmatic patients. Syncroner Trial Research Group].
An open multicenter randomized, cross over study has compared the patients acceptance and preference of nedocromil sodium delivered as metered dose inhaler (MDI) containing 112 puffs and attached to an open tube spacer, the Syncroner with the same product as MDI containing 56 puffs delivered through a standard mouthpiece adaptator. One hundred and forty four patients (67 males) suffering from moderate asthma (mean FEV1: 86%) aged 18 to 70 years received alternatively 2 puffs of 2 mg 4 times a day of nedocromil sodium either by Syncroner or by the standard adaptator for two weeks in random order. The acceptance of each device was assessed by a questionnaire after two weeks of treatment. At the end of the study, the preference was recorded globally by the mean of a visual analog scale and for each of the following criteria: tolerability, shape, efficacy, hygiene, easiness to use, cleaning, contents and confidence. After two weeks of treatment the Syncroner was as well accepted as the standard mouthpiece and even better in terms of contents, cleaning and confidence. At the end of the study, 50.4% of patients prefering the Syncroner and 49.6% the standard mouthpiece. Patients significantly favoured the Syncroner because of its contents, hygiene, and cleaning (p < 0.05 for these 3 criteria) and tolerability (p = 0.07). In conclusion, after two weeks of treatment, the Syncroner was as well accepted as the standard MDI, 50% of patients preferred the new inhalation device. Considering its interest as training aid and the better lung deposition, it can be proposed for drug delivery without risk of a rejection by patients.
Administration, Inhalation↗