A 6-month comparison between formoterol and salmeterol in patients with reversible obstructive airways disease.

The aim of this randomized, open, parallel group study was to compare the clinical efficacy of formoterol dry powder capsule 12 micrograms b.i.d. and salmeterol dry powder 50 micrograms b.i.d. in the treatment of patients with reversible obstructive airways disease. The 6-month treatment was preceded by a 2 week run-in period. Morning pre-dose peak expiratory flow (PEF) during the last 7 days of treatment was the primary variable. Throughout the study, patients recorded morning and evening pre-dose PEF, use of rescue medication, respiratory symptoms and adverse events. Clinic visits were scheduled at monthly intervals. Of the 482 patients randomized (equal numbers in the two treatment groups), 428 completed the study. Four hundred and twenty-five patients were included in the efficacy analysis for the primary variable. For mean morning pre-dose PEF during the last 7 days of treatment, the 95% confidence interval (CI) for the treatment contrast formoterol minus salmeterol was included entirely in the pre-defined range of equivalence (CI limits = -8.69, +9.841 min-1). This was also the case for the morning PEF during the last week before each clinic visit. For mean evening pre-dose PEF, the estimated treatment contrasts showed a trend towards superiority of formoterol over salmeterol, which became statistically significant at 2, 3 and 4 months (P < 0.05; estimated contrasts 7.27, 10.45 and 10.511 min-1, respectively). No treatment group differences were found in use of rescue medication and respiratory symptom scores. The incidence of adverse events was similar in the two groups. These findings demonstrate that formoterol 12 micrograms b.i.d. and salmeterol 50 micrograms b.i.d., both formulated as dry powders, have similar long-term efficacy and safety profiles in patients with reversible obstructive airways disease.

[Prevalence of tobacco dependency and its prevention in patients with persistent asthma]. / Prevalencia del tabaquismo y prevención en pacientes con asma persistente.

OBJECTIVES: To analyse in patients with persistent bronchial asthma the prevalence of tobacco dependency and its degree; and to assess measures of prevention. DESIGN: Cross-sectional, descriptive study. SETTING: Allergy Service of the Lozano Blesa University Hospital, Zaragoza, Spain. PARTICIPANTS: A total of 121 patients, from systematic selection of asthmatics attending for consultation. MAIN MEASUREMENTS: Questionnaire filled out in the consulting room, recording social, demographic and clinical variables. RESULTS: A sample of 121 patients was obtained, 62.7% women and 37.3% men. They had 5.87 +/- 4.99 years mean evolution of asthma. 21.5% were daily smokers, 4.1% occasional smokers, 27.3% ex-smokers, and 47.1% non-smokers. The ages of starting to smoke were < 10 years old, 1.7%; 10-15, 30%; 15-20, 56.7%; 20-25, 6.7%, and > 25, 5% (P > .05). There were significant differences between gender and tobacco dependency and between age and tobacco dependency (P < .01 and P < .014, respectively). 96.8% of smokers thought that tobacco was harmful to their health. This figure was 100% in daily smokers and 80% in occasional smokers (P < .02). 83.9% of smokers had the intention of giving up. Counselling to give up was received from the specialist (41.9%), the primary care doctor (12.9%), and both (9.7% of cases). 35.5% received no counselling. CONCLUSIONS: The prevalence of tobacco dependency in patients with persistent asthma is lower than in the population as a whole; over a third receive no counselling about giving up. Interventions must be conducted in still healthy smokers and chronically ill patients in both primary and specialist care.

[An analysis of the treadmill exercise test in a population of mild and moderate extrinsic asthmatics]. / Análisis de la prueba de ejercicio de la cinta sin fin en una población de asmáticos extrínsecos leves y moderados.

The bronchial response to physical exercise on a treadmill was analyzed in 48 patients with mild to moderate extrinsic asthma diagnosed by clinical criteria and a positive methacholine test, and in 36 non-asthmatic subjects. Bronchoconstriction secondary to physical exercise was documented by measuring the percent fall in PEF in different post-exercise control times. Significant differences (p < 0.00001) were observed between bronchial response in asthmatic and non-asthmatic patients. By using ROC curves an optimal cut-off was obtained in a fall equal to or greater than 6% 10 minutes post-exercise, with a sensitivity of 0.75 and an specificity of 0.923. The bronchial challenge test with physical exercise on a treadmill, within the limits of the studied sample, can be used as a method for detecting BHR in asthmatic patients.

[Study of helper T lymphocytes and suppressor T lymphocytes in respiratory allergy and their modifications in relation to symptomatology]. / Estudio de linfocitos T facilitadores y T supresores en alergia respiratoria y sus modificaciones en relación a la sintomatología.

In has been assumed that in allergic disease there is a primary disorder in the lymphocyte subpopulation with decrease suppressor activity responsible for the pathological increase in IgE. Other authors have found secondary disorder in T lymphocyte subpopulations in relation to the clinical manifestations of the type I hypersensitivity reaction. We have studied the T lymphocyte subpopulations in 152 patients affected with bronchial asthma and/or extrinsic allergic rhinitis (without immunotherapy) in which 72 were male and 80 female with an average age of 26.49 +/- 12.05 years. Monoclonal antibody techniques were used (OKT4 for helpers and OKT8 for suppressors). The results were compared with 30 healthy controls; 60 males and 14 females with an average age of 32.52 +/- 14.23 years. We also studied the T lymphocyte subpopulations in relation to the symptomatology presented by the patients. The results were as follows: Significant decrease in helper and suppressor lymphocytes in allergic patients as compared to controls (p less than 0.001). No significant differences were found between the groups in relation to symptomatology (p greater than 0.05). In our study we found an important and significant decrease in helper T lymphocytes in peripheral blood in patients with respiratory allergy as compared to the control group, such as that found by Hsieh who also observed a deficient OKT4 function. Other authors have also observed a significant decrease in helper T lymphocytes parallel to the symptomatology of the type I hypersensitivity reaction, a finding that we have been unable to confirm in our study since no significant changes were observed between the symptomatic and asymptomatic patients.(ABSTRACT TRUNCATED AT 250 WORDS)

[Fungi inside and outside the homes of subjects with immediate hypersensitivity in Zaragosa (Spain)]. / Estudio de los hongos intra y extradomiciliarios en sujetos con hipersensibilidad inmediata en Zaragoza (España).

In the study of patients with hypersensitivity to atmospheric fungi, the determination of species distribution in the personal environment of the patient is important. This distribution depends on climate variations, especially temperature and percent (%) humidity which favor the development of one or other genera. In the domiciliary surroundings, the technological advances in comfort (wetness, dryness, with refrigeration and heating systems) favor the establishment of a closed ecosystem which can sometimes contain fungi different from that found exteriorly; at times true colonization. Our objective is to compare the incidence of the different groups of intra and extra-domiciliary fungi in our environment (Zaragoza, Spain) and to verify their presence in the domiciles with their exterior surroundings, of 23 atopic patients, of which 8 had clinical asthma and/or rhinitis and demonstrable allergy to fungi, by PRICK and RAST. The other 15 patients were diagnosed as having asthma and/or rhinitis with a positive PRICK and RAST to house dust and Dermatophagoides or pollen allergens (non-allergic to fungi). Five Petri dishes were given to each patient; one dish contained 5 mm. of Agar-Sabourad following Lumpkins' formula, and was used for extra-domiciliary exposure. The rest contained the same medium to which was added a 0.33% solution of Rose Bengal (an inhibitor) for internal exposure. This medium allows the development of a large number of genera of fungi. These 5 dishes were situated and remained in place for 60 minutes; the 4 interior ones were placed in different locations and always included the dormitory and living room.(ABSTRACT TRUNCATED AT 250 WORDS)

[The usefulness of theophylline in the treatment of moderate-severe asthma]. / Utilidad de la teofilina en el tratamiento del asma moderada-severa.

Theophylline has shown itself to be a useful bronchodilator in the treatment of asthma, although its use has been restricted of late due to its lesser potency and greater side effects when compared with beta-adrenergic inhalants. The objective of our study is to evaluate its clinical effectiveness in moderately severe asthma. We study 12 patients with stable chronic asthma on whom a spirometry in basal conditions was performed and after therapeutic levels of theophyllinemia were reached. Peak flow and clinical symptomatology were monitored during one-week periods in both phases of the study. Daytime and night-time symptoms were evaluated independently. No significant changes were observed in the spirometric values. No changes were observed in the bronchodilation test, the concomitant consumption of bronchodilators, or in the maximum expiratory fluids. However, significant differences were observed in the overall computation of symptoms and in the quantification of nocturnal symptoms. We conclude that retarded theophylline presents little usefulness in the treatment of asthma, even though its use can be recommended as symptomatic treatment of nocturnal asthma given its prolonged bronchodilating effect.

[Persistence of nonspecific bronchial hyperreactivity in children with non-IgE dependent bronchial asthma: pharmacologic study with the Carbachol test]. / Persistencia de la hiperreactividad bronquial inespecífica en niños con asma bronquial no IgE dependientes: estudio farmacológico mediante test de carbacol.

The authors revise their preliminary experiment with the bronchial provocation test using carbachol in 50 children of 5 to 14 years with non-IgE dependent bronchial asthma who had been asymptomatic for one year prior to the test in order to make a clinical evaluation of asthma. The observe the evolution of the non-specific bronchial hyperreactivity (NSBH) with respect to the clinical remission and determine whether the persistence of NSBH is correlated to certain clinical, epidemiological and analytical parameters (peripheral eosinophilia, total IgE). In 22 children (44%) the functional respiratory examination was normal throughout each phase of the test. In the other 56%, the functional respiratory study using carbachol showed exhalation reductions which suggested NSBH. The most significant parameters were the reductions in FEV1, PEF (p less than 0.001) and FMEF (p = 0.001). Thus the patients revealing NSBH in the carbachol test are characterised for having revealed acute asthma of higher intensity, more often associated with an acute respiratory infection and with lower values of total IgE (p less than 0.05) with respect to the group without NSBH in the carbachol test.

[Usefulness of total and specific IgE in the diagnosis of respiratory allergy]. / Utilidad de la IgE total y específica en el diagnóstico de la alergia respiratoria.

We studied 500 patients with an average age of 36.25 +/- 14.27 years and did the following tests: Intradermoreaction and prick tests, total IgE by PRIST and specific IgE by RAST. The antigens used for the study were the following: Lolium Perenne, Dermatophagoides pteronyssinus, and house dust. Of de 500 patients studied, 104 had a negative skin test and RAST. They also had a negative history of allergy. The other 396 patients presented a clinical history compatible with the diagnosis of allergy and were positive to skin test and/or RAST. A correlative study between the different techniques utilized in the diagnosis of these patients was undertaken. We observed significant higher levels of total IgE in the allergic than in the non-allergic group (p less than 0.001). The normal levels of total IgE in our environment were equal or inferior to 263.33 UI/ml. In the group of allergic patients, levels higher than 263.33 UI/ml were found in 49.27% of RAST positive patients and 46.35% in skin test positive patients. In the 295 patients studied with intradermoreaction, the correlation coefficients (r) were as follows: Lolium perenne r: 0.90; Dermatophagoides Pteronyssinus r: 0.54; house dust r: 0.14. The correlation coefficients (r) in the 101 patients studied with prick tests were the following; Lolium perenne r: 0.86; Dermatophagoides Pteronyssinus r: 0.82; house dust r: 0.48. As can be observed the prick tests gave overall better results than the intradermoreaction. On comparing the skin and RAST tests qualitatively we observed that in those patients studied by prick tests, 86.79% were pollen-positive in both trials.(ABSTRACT TRUNCATED AT 250 WORDS)

Personal sanitario e industria farmacéutica / Health care professionals and the pharmaceutical industry

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Tratamiento combinado en el asma: ¿siempre una constante? / No disponible

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