An open, randomized, parallel-group study was conducted to investigate whether asthmatic patients, considered adequately treated with a corticosteroid and/or short-acting beta 2-agonist via pressurized metered-dose inhaler (pMDI), could be transferred to a corresponding nominal dose of budesonide and/or terbutaline via Turbuhaler, an inspiratory flow-driven multidose dry powder inhaler (Astra Draco; Lund, Sweden), without a decrease in the effect of treatment. One thousand four patients (555 women; mean age, 44 years; mean peak expiratory flow [PEF], 102% predicted normal value) were randomized and treated with either pMDI (current therapy) or Turbuhaler for 52 weeks. The variables studied were asthma-related events, morning PEF, and inhaler-induced clinical symptoms. Asthma-related events were defined in two ways: (1) sum of health-care contacts plus doublings or additions of steroids, and (2) number of 2 consecutive days with PEF less than 80% of baseline. Baseline was obtained from a 2-week run-in period while receiving previous therapy. No statistically significant difference was found in asthma-related events according to definition 1. According to definition 2, there was a statistically significant difference between the groups in favor of Turbuhaler (p = 0.008). The mean number of events was 1.7 with Turbuhaler and 2.2 with pMDI. The mean number of weeks per patient with a PEF less than 90% of baseline was 4.5 with Turbuhaler compared with 6.0 with pMDI (p = 0.002). The sum of inhaler-induced symptoms after 1 year of use was statistically significantly lower with Turbuhaler (0.40) than with pMDI (0.75) (p = 0.0001). In conclusion, budesonide and terbutaline in Turbuhaler offered a superior alternative to corticosteroids and bronchodilators delivered by pMDIs in the maintenance treatment of asthma.
Thirty-one adult patients with asthma caused by house-dust mites (HDM) were included in this placebo-controlled, double-blind study to evaluate the efficacy and safety of specific immunotherapy (SIT) with biologically standardized extracts of HDM. The specific diagnosis was confirmed by skin prick tests, specific IgE, and bronchial provocation tests with HDM allergens. The patients were randomized to receive active treatment with extracts of either Dermatophagoides pteronyssinus (Dpt) or D. farinae (Dfa) (Alutard SQ, ALK, Denmark) or placebo injections. Twenty-three patients completed the study. After 1 year of treatment, we found a clinically important and significant reduction in both asthma medicine consumption (inhaled steroids 38% and beta 2-agonists 46%) and symptom score (57%) in the actively treated group, but not the placebo group. These findings were confirmed by a significant decrease in skin and bronchial sensitivity to HDM in the active group. Additionally, there was a significant difference in the patients' scores for effect in favor of the actively treated group. Total IgE and specific IgE to HDM showed no significant changes before and after treatment for either group. Spirometric lung-function measurements showed a significant increase in forced expiratory volume in 1 s (FEV1) from 85% before to 89% of predicted values after treatment for the actively treated group. Peak-flow measurements at home showed no significant changes during the study. It is concluded that allergen SIT is an effective treatment in adult patients suffering from asthma due to HDM.
Nedocromil sodium is a pyranoquinoline dicarboxylic acid derivative, formulated in a metered-dose inhaler. Because nedocromil sodium has in vitro and in vivo anti-inflammatory properties, it was evaluated in a group of steroid-dependent patients with asthma to observe how well it might be tolerated and for evidence of any beneficial effects. In a double-blind, group-comparative study, 127 patients received nedocromil sodium and 61 received placebo, administered as two puffs of 2 mg, four times per day, for 12 weeks. Ten patients developed adverse reactions, seven receiving active drug and three patients receiving placebo. Two patients of each group withdrew because of worsening asthma. Despite selecting patients whose asthma was stable, when they were receiving established therapeutic regimens that included steroids and bronchodilators, it was found that diary-card symptom scores, morning and evening peak expiratory flow rate values, and inhaled beta-agonist usage all demonstrated slight but significant benefit with addition of nedocromil sodium. It is concluded that the inhaled, anti-inflammatory agent, nedocromil sodium, may be added to asthma-treatment regimens with the reasonable expectation of further modest symptomatic benefit.
Although increases in inhalable particle (PM10) concentrations have been associated with acute reductions in the level of lung function and increased symptom reporting in children, including children with asthma, it is not clear whether these effects occur largely in asthmatic children, or even whether asthmatic children are more likely to experience these effects than children without asthma. To address these points, the following subgroups of children were selected from a survey population of all 2,200 elementary school children (6 to 13 yr of age) in a pulp mill community on the west coast of Vancouver Island: (1) all children with physician-diagnosed asthma (n = 75 participated), (2) all children with an exercise-induced fall in FEV1 without diagnosed asthma (n = 57), (3) all children with airway obstruction (FEV1/FVC
During the winter of 1994, the association between daily changes in air pollution and in the respiratory health of children 7 to 12 yr of age were studied in Kuopio, Finland. Seventy-four children with asthmatic symptoms and 95 children with cough only, living either in urban or suburban areas, were followed for 3 mo. During the study period, the mean daily concentration of particulate air pollution (PM10) was 18 micrograms/m3 in the urban area and 13 micrograms/m3 in the suburban area. Lagged concentrations of PM10, black smoke, and NO2 were significantly associated with declines in morning peak expiratory flow (PEF) among asthmatic children. The regression coefficient (x10) for a 2-d lag of PM10 was -0.911 (SE, 0.386) in the urban and -1.05 (0.596), in the suburban area. Among children with cough only, PM10, black smoke, and NO2 were not significantly associated with PEF. In the urban area, there was a significant association between SO2 and morning and evening PEF and incidence of upper respiratory symptoms among children who cough only. No other associations between air pollution and evening PEF or respiratory symptoms were observed. This study suggests that particulate air pollution is associated with respiratory health, especially among children with asthmatic symptoms.
A comprehensive investigation forming part of a joint European study under the auspices of "WHO Long-Term Air Pollution Programme" uses 7-13 year old schoolchildren as the target group. The study has included social, housing, hygienic and epidemic factors as well as family smoking habits. The results indicate that, at exposure to low levels of air pollution, these factors dominate as causes for the impairment of health especially that of respiratory health.
BACKGROUND: Up to 5% of patients with dermatitis who are consecutively patch tested are allergic to one or more corticosteroids. However, few reports of allergic mucosal and skin symptoms in patients with asthma and rhinitis caused by inhaled corticosteroids exist. OBJECTIVE: Our purpose was to determine whether inhalation of budesonide would result in reactivation of patch test reactions caused by budesonide. METHODS: The study, which was randomized, double-blind, and placebo-controlled, was ethically reviewed by the Medical Faculty, University of Lund, Sweden. Fifteen nonasthmatic patients who were initially given a diagnosis of budesonide hypersensitivity on patch testing from less than 1 up to 8 years before the study were provoked with budesonide or placebo by inhalation 6 weeks after they had been patch tested with budesonide, its R and S diastereomers, and potentially cross-reacting substances. Lung function was studied by using spirometry and repeated peak expiratory flow measurements. RESULTS: In 4 of 7 patients who inhaled budesonide, reactivation of previously positive patch test reactions was noted within 24 hours, in contrast to 0 of 8 patients who inhaled placebo (P =.026). No adverse pulmonary responses could be detected. CONCLUSION: This study shows that allergic skin reactions may occur in patients with contact allergy to budesonide when inhaled forms of the drug are used.
OBJECTIVE: To investigate how physiologic dysregulation, in terms of allostatic load and clinical risk, respectively, relates to sense of coherence (SOC) in women with no previously diagnosed pathology. METHODS: At baseline, 200 43-year-old women took part in a standardized medical health examination and completed a 3-item measure of SOC, which they completed again 6 years later. According to data from the medical examination, two different measures of physiologic dysregulation were calculated: a) a measure of allostatic load based on empirically derived cut points and b) a measure of clinical risk based on clinically significant cut points. RESULTS: In line with the initial hypotheses, allostatic load was found to predict future SOC, whereas clinical risk did not. In addition to baseline SOC and nicotine consumption, allostatic load was strongly associated with a weak SOC at the follow-up. CONCLUSIONS: The better predictive value of allostatic load to clinical risk indicates that focusing solely on clinical risk obscures patterns of physiologic dysregulation that influence future SOC.
OBJECTIVE: Determination of the urinary concentration of eosinophil protein X (U-EPX) may objectively predict the severity and activity of asthma in children. METHODS: Concentrations of U-EPX in 80 non- atopic asthmatic children were compared with those in 25 healthy control children. The patients were studied during attacks and two weeks later. The severity of asthma attacks was determined according to a pre-existing score. U-EPX was measured by the specific radioimmunoassay technique (Pharmacia, Uppsala, Sweden). This measurement was correlated with the clinical and radiological investigations as well as with other variables such as blood oxygen saturation, peak expiratory rate and eosinophil count. RESULTS: U-EPX concentrations were significantly higher in all asthmatic children during attacks (139.6 11.7 microg/mmol of creatinine) than those in the control group (35.3 6.2 microg/mmol of creatinine) (p
To address the recent rise in asthma morbidity and mortality in Russia, an intervention study was conducted to improve asthma diagnosis, treatment and prevention. US recommendations for asthma management were adapted for use in educating Moscow families with children with asthma. Two hundred and fifty-two children with asthma aged 4-14 years receiving health care in eight Moscow public health clinics together with their parents were enrolled in the study to see whether US teaching manuals for asthma management would be acceptable and effective in Russia. Children at four of the clinics with recent asthma attacks were randomly assigned to either the education or control group to test if patient education and guided asthma care would improve outcomes for patients. Modern medications were made available to both groups to see if training in the US guidelines was necessary to get physicians to use the medications. Children with recent asthma attacks at the other four clinics were defined as comparison group 1 to control for the possible effect of medication availability. All children at the eight clinics who had no asthma attacks composed comparison group 2 to see if the outcomes for these children would change over time. One-year follow-up results showed significant improvement in asthma self-management skills of children and parents, in terms of asthma treatment, only among those in the education group. Significant increases were observed in the subgroup of children in the education group using anti-inflammatory drugs for asthma control. Children in the education group had markedly increased peak flow rates and reduced daily peak flow variability as compared to control and comparison groups. There was a significantly greater reduction in doctor visits by the education group of children compared to control. Presumably, changes in parents' and children's behaviour in terms of asthma treatment and prevention skills, proper treatment of the disease and access to medications could be responsible for reducing asthma morbidity in children.