[Cetirizine. A new non-sedative antihistaminic agent].
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Cetirizine↗
Biomedical subjects
L Frølund
Publications and source records attributed to L Frølund.
[Alcohol. Treatment in the ambulatory clinic is not enough].
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Adult↗
A comparison of the effects of nedocromil sodium and beclomethasone dipropionate on pulmonary function, symptoms, and bronchial responsiveness in patients with asthma.
The efficacy of nedocromil sodium (NED) (4 mg twice daily) and beclomethasone dipropionate (BDP) (200 micrograms twice daily) in controlling the symptoms of asthma, the pulmonary function, and bronchial responsiveness to histamine was assessed in a double-blind, double-dummy, crossover study of 39 adult patients with chronic asthma. The patients, most of whom were assessed to be affected to a moderate degree, were insufficiently controlled in their current regimen of inhaled and/or oral bronchodilators. A 2-week baseline period preceded 6 weeks of treatment with each of the study drugs. Both treatment groups demonstrated improvements from baseline in clinical assessment of lung function performed after the first 6 weeks of treatment. No significant differences were observed when the effects of the treatments were compared on FEV1, FVC, and peak expiratory flow. Bronchial reactivity to histamine, measured as the amount of histamine causing a 20% fall in FEV1 (PC20), decreased significantly (p less than 0.05) after 6 weeks of treatment with BDP compared to the effect of NED treatment. Asthma severity, symptom score, and inhaled bronchodilator use demonstrated significantly better results with BDP. After crossover of treatment, the group transferring from NED to BDP continued to improve, whereas the group crossing from BDP to NED tended to demonstrate a major deterioration during the first 3 weeks, after which a stabilization or an increase in FEV1, FVC, and ln PC20 appeared to occur. It is concluded that NED for inhalation is a potent new drug for treatment of both atopic and nonatopic subjects with asthma. With the number of patients and dosages used, the effect on the pulmonary function was not significantly different from that of BDP after the initial 6 weeks of treatment, but BDP had a better effect on asthma severity, overall opinions, symptom score, bronchodilator use, ln PC20, and morning peak expiratory flow.
Adult↗
Beclomethasone dipropionate versus flunisolide as topical steroid treatment in patients with perennial rhinitis.
After a 2-week run-in period 23 atopics and non-atopics with perennial rhinitis were treated with intranasally nebulized aqueous flunisolide or aqueous beclomethasone dipropionate in a randomized, double-blind cross-over study, each treatment period being 4 weeks. Before and after each treatment period daily rhinitis symptoms were recorded, and additional determination of nasal airway resistance was performed by posterior rhinomanometry. No statistically significant difference between drugs was observed for any effect parameter recorded, and furthermore no difference in patient preference for either drug was found. It is concluded that both steroids are effective for the improvement of nasal airway in patients with perennial, atopic and non-atopic rhinitis.
Administration, Intranasal↗
A comparison of two RAST methods and skin prick testing in the diagnosis of wasp venom allergy.
With the aim of evaluating the correlation between skin prick test and two radioallergosorbent tests (RAST) using paper (P-RAST) and Al(OH)3 (Al-RAST) as sorbent materials, 45 consecutive patients known to have been stung by wasp within 6 months were examined. Four patients had a normal reaction, four a large local reaction and 37 a systemic reaction. We found a good correlation between a systemic reaction and a positive P-RAST. Fifty-one per cent of patients with a systemic reaction had a negative Al-RAST, whereas only 8% had a negative P-RAST. Eight per cent of patients with a systemic reaction had a negative SPT. In the eight patients without a systemic reaction, the same patient reacted positively in Al-RAST and P-RAST.
Adolescent↗
A new formulation of flunisolide for intranasal application reduces side effects.
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Administration, Intranasal↗
Hyposensitization in asthmatics with mPEG modified and unmodified house dust mite extract. I. Clinical effect evaluated by diary cards and a retrospective assessment.
Forty-six asthmatics with verified allergy to the house dust mite, D. pteronyssinus (Dp), participated in a double-blind study comparing the effect of 2 years' hyposensitization with two different Dp extracts. Two groups received either monomethoxypolyethylene glycol modified (mPEG) Dp extract or the corresponding non-modified extract, and a third group acted as controls receiving no injections. Medicine consumption, symptom scores, and peak expiratory flow (PEF) were recorded daily from September to December prior to and after 6 and 18 months of treatment. Changes were calculated choosing changes greater than or equal to 10% as relevant. In addition, patients were asked to give their direct assessment of the clinical effect at the end of the study. After 6 months, there was an improvement in symptoms + medication in 11/14 of Dp-treated, 6/17 of the mPEG-Dp group (P greater than 0.05) and 3/15 of openly treated controls. Few patients had changed in PEF. During the second year, several Dp-treated relapsed and some controls improved. At the end of the study the same improvement rate was seen in all groups. Similarly, the retrospective questionnaire data did not disclose any significant differences between groups after 2 years. In conclusion, hyposensitization with unmodified Dp extract seemed to have a favourable short-term effect on bronchial symptoms + medication in the majority of patients. When mainly on maintenance dose, the beneficial effect was reduced. The mPEG modification of the extract had reduced not only allergenicity but also the clinical effect of equal doses. Changes in medicine and symptom scores only partly correlated to retrospective assessment, thus stressing the problems in this kind of evaluation.
Animals↗
Hyposensitization in asthmatics with mPEG modified and unmodified house dust mite extract. II. Effect evaluated by challenges with allergen and histamine.
In a 2-year study, 46 asthmatics with verified allergy to the house dust mite D. pteronyssinus (Dp) were included either as controls (Ctls) or receiving hyposensitization (HS) with unmodified or monomethoxypolyethylene glycol (mPEG) modified Dp-extract. Patients were monitored by annual challenges with histamine in bronchi, and Dp allergen in bronchi, nose and conjunctiva. mPEG-modified extract was not inferior to unmodified Dp-extract; both were to some extent able to improve tolerance to Dp and histamine in bronchi and to Dp in nose and eyes. During the 1st year, the bronchial sensitivity to Dp decreased significantly in the HS groups but not in the Ctls. During the 2nd year, improvement was more pronounced in the Ctl group. The relative increase in Dp or histamine tolerance did not differ significantly between groups after either 1 or 2 years; the only exception was conjunctival sensitivity, which in the Ctl group was unchanged, and a 10-fold increase in tolerance in the HS groups. No direct benefit was seen on late-phase bronchial reactions. In patients with improved pulmonary symptoms a tendency was seen towards reduced sensitivity to histamine and Dp. Variation within groups was extensive.
Animals↗
Effect of a non-sedative antihistaminic (loratadine) in moderate asthma. A double-blind controlled clinical crossover-trial.
Seventeen patients with perennial asthma, stable on a moderate dose of inhaled steroid, participated in a crossover study comparing the clinical effect of a non-sedative, potent and highly selective H1 antagonist (loratadine 10 mg) with placebo. Each treatment period began with 2 weeks run-in followed by 8 weeks on either antihistamine or placebo. During the 8-week periods inhaled steroid was gradually tapered according to a fixed scheme. One patient was withdrawn from active treatment and three from placebo periods because of decreasing lung function (P greater than 0.1). Among the remaining 13 patients there was a threefold (1.8-4.8) decrease in the bronchial sensitivity to histamine during treatment with antihistamine compared to placebo (P less than 0.01). There was a trend in favour of active treatment with regard to changes in all symptom scores, lung function and use of escape medication, but these differences were not statistically significant. The increase in FEV1 was less than 5% of predicted normal (P less than 0.05). We concluded that the bronchial response to histamine can be attenuated by loratadine, an oral H1 receptor antagonist, but further studies are necessary to assess the clinical usefulness and place of loratadine in the therapy of asthma.
Adult↗
Comparison between steady state pharmacokinetics and effects of two once-daily, slow-release theophylline formulations in nocturnal asthma.
The effects on bronchoconstriction, on non-specific bronchial hyperreactivity (nBH), and the pharmacokinetics at steady state of two theophylline preparations, controlled release (CR) capsules (Riker Pharmaceuticals) and UnixanR tablets (Pharmacia) were compared in patients with nocturnal asthma. Doses were individualised with the intention of achieving plasma trough concentrations greater than 8 micrograms/ml with CR-capsules. The same dose of the two formulations was taken in the morning during two 2-week periods in a randomised, double-blind, cross-over design. During a 24 h hospital study day at the end of the two periods, pulmonary function tests, blood samples, and bronchial histamine challenges were performed. Eleven patients completed the study. Doses were median 15 mg/kg (range 10-20). FEV1 and PEF were statistically significantly better (p less than 0.05) 24 h after dosing (08:00) with CR-capsules. No statistically significant changes in nBH were demonstrated. Despite no significant differences in extents of absorption, the plasma theophylline concentration fluctuations were significantly less (p less than 0.001) during treatment with CR-capsules. We found CR-capsules superior to Unixan in pharmacodynamics 24 h after dosing and in pharmacokinetics with equal bioavailability. In nocturnal asthma the pharmacodynamic differences may be eliminated with evening dosing. No statistically significant changes in nBH were observed.
Adult↗
Stability of histamine dihydrochloride in solution.
Histamine dihydrochloride (HC) is one of the bronchoconstrictors used for bronchial challenge. Information on the activity of HC dilutions during storage is desirable (4). Activity, bacterial, and fungal contamination of stored HC dilutions were tested after storage at 20 degrees, 4 degrees, and -18 degrees C. HC dilutions with a concentration of and below 0.25 mg/ml have a significantly reduced activity after 1 month's storage at 20 degrees C and should at present be used within 1 week to ensure the presence of the expected activity. The activity of HC dilutions stored at 4 degrees C or -18 degrees C was stable for at least 6 months. Upon delivery from a pharmacy we detected no bacterial or fungal contamination of HC dilutions by means of the method used. Before 3 months' storage, and independently of storage temperature, bacterial contamination was not found. After 3 months' storage, bacterial contamination was found in HC dilutions with a concentration below 0.5 mg/ml. No fungi were isolated. HC dilutions with a concentration of 0.25 mg/ml and below should not be stored for more than 1 month and should be used within 1 week of opening.
Cold Temperature↗
A multicentric study of loratadine, terfenadine and placebo in patients with seasonal allergic rhinitis.
This multicentric study compared 14-day treatment with loratadine (Clarityne) 10 mg once daily, terfenadine 60 mg twice daily and placebo in outpatients with seasonal allergic rhinitis. Of 275 patients enrolled, 256 (87 in the loratadine group, 89 in the terfenadine group and 80 in the placebo group) were evaluable for efficacy and 266 (90, 91 and 85 in respective groups) were evaluable for safety. Investigators graded the severity of 4 nasal and 4 nonnasal signs/symptoms and investigators and patients rated overall disease condition and therapeutic response on treatment days 3, 7 and 14; patients recorded when signs/symptoms of rhinitis were relieved, as well. Hematology and blood chemistry tests were conducted before and after therapy, and patients were questioned throughout the study about possible adverse experiences. At all visits, loratadine and terfenadine were significantly superior to placebo (p less than or equal to 0.004), and the two active medications were statistically comparable, based on mean totals of sign/symptom severity scores and ratings of overall disease condition and therapeutic response. By patients' last valid visit, mean totals of sign/symptoms severity scores improved by 56% and 53% for loratadine and terfenadine groups, respectively, but exacerbated by 5% for the placebo group. Moreover, an excellent or a good therapeutic response was observed in 58/87 (67%) loratadine-treated patients and 58/89 (65%) terfenadine-treated patients, as compared to 13/80 (16%) placebo-treated patients (p less than 0.01). A total of 61/76 (30%) patients in the loratadine group and 57/78 (73%) in the terfenadine group versus 22/71 (31%) in the placebo group experienced relief within the first 3 days of therapy (p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)
Adolescent↗
[Standardized provocation for determination on non-specific bronchial reactivity].
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Bronchial Provocation Tests↗
A comparison of the effects of sodium cromoglycate and beclomethasone dipropionate on pulmonary function and bronchial hyperreactivity in subjects with asthma.
After a run-in period of 2 weeks, receiving a regimen of inhaled beta 2-agonists and/or theophyllines, 38 atopic patients with asthma with perennial symptoms were randomly allocated to receive an 8-week treatment of additional inhalation treatment with either sodium cromoglycate (SCG), 2 mg four times daily, and placebo beclomethasone dipropionate (BDP), or BDP, 200 micrograms twice daily, and placebo SCG. After crossover, each group received the opposite treatment for the final 8 weeks. FEV1, FVC, and provocation concentration of histamine causing a 20% fall in FEV1 (PC20) were determined monthly and peak expiratory flow (PEF) daily throughout the study. A significant increase in FEV1, FVC, and PEF (p less than 0.01) was observed after BDP treatment was started, and likewise, in the second period, an increase in both FEV1 and PEF (p less than 0.05) was observed. The total effect on logarithm-natural (Ln) (PC20), i.e., the mean effects of the two periods, was also significant (p less than 0.01). SCG, however, was most effective when it was used as the first drug, indicated by a significant increase in FVC in the first period (p less than 0.05). Neither in the first nor in the second period did SCG treatment influence the Ln (PC20) value positively, and the SCG treatment administered in the second period could not maintain the improvement in the pulmonary function (i.e., FEV1, FVC, and PEF) obtained initially with the BDP treatment. When the effect of BDP on FEV1, FVC, PEF, and Ln (PC20) was compared to the effect of SCG in the first 8-week treatment period, no significant difference was observed (p greater than 0.1).(ABSTRACT TRUNCATED AT 250 WORDS)
Adult↗
Reproducibility of responsiveness to a standardized bronchial allergen provocation-Rt compared to FEV1 as measurement of response to provocation.
Standardized bronchial allergen provocation was performed twice in nineteen extrinsic, well defined, stable asthmatic patients, with an interval of median 15 days (range 14-19) to study the reproducibility of the bronchial response. Smoking and medications were withheld prior to the provocation after a rigid scheme. Ten-fold increasing concentrations of allergen solution 0.9 ml were inhaled by tidal volume breathing for 5 min with intervals of 10 min. The bronchial response to inhaled allergen was determined by forced expiratory volume in the first sec (FEV1) and by total resistance to breathing (Rt) determined by an opening interrupter method. The provocation was continued until an allergen concentration causing at least 20%, decrease of the postsaline FEV1 or a 40% increase in Rt was reached. A PC20-FEV1 and a PC40-Rt was calculated by interpolation on the log-dose-response curve. The reproducibility of PC20-FEV1 allergen was high with a 95% confidence interval (CI) for a single determination being the observed value +/- 0.83, ten-fold concentration difference, the intraclass correlation (IC) was 0.99 and the coefficient of variation 8.46%. Concerning PC40-Rt a 95% CI for a single determination was calculated being the observed value +/- 0.58, ten-fold concentration difference, IC was 0.99 and the coefficient of variation was 5.79%. No significant correlation was found between differences in pre-challenge FEV1 and Rt values and the corresponding PC20-FEV1 and PC40-Rt values. Least square regression between PC20-FEV1 and PC40-Rt was performed for the first and the second provocation (P less than 0.05). We conclude that bronchial allergen challenge performed in stable asthmatics is highly reproducible and as such a valuable test in the diagnosis of allergic asthma when connected with anamnesis, skin-prick test and the level of specific immunoglobulin E in peripheral blood.
Adolescent↗
Bronchial allergen challenge: comparison between two different methods of provocation.
Bronchial allergen challenge was performed twice in ten well-defined stable asthmatic patients. On each provocation day the allergen was administered either by a standard method at tidal volume breathing or by a dosimeter method. Ten-fold increasing concentrations of allergen were administered with an interval of 10 min. Total amount of allergen of 9, 90, 900, 9000 and 90,000 SQ units using the standard method, whereas the corresponding amount by the dosimeter method was 0.5, 5, 50, 500, and 5000 SQ units. The bronchial response was determined by forced expiratory volume in the first second (FEV1) and by total resistance to breathing (Rt) measured by an opening interrupter method. The provocation was stopped when a decrease of at least 20% of the post-saline FEV1 and a 40% increase in post-saline Rt was observed. A PC20-FEV1 and a PC40-Rt was calculated by interpolation on the log dose-response curve. The late reaction was recorded and defined as a 20% reduction in peak expiratory flow (PEF) occurring during the 24-hr period after challenge. The comparability of PC20-FEV1 and PC40-Rt obtained with the standard method and with the dosimeter was high, r = 0.89 and r = 0.88. Furthermore, no significant difference was found by comparing delta FEV1 and delta Rt during provocation by either method as well as the occurrence and magnitude of the late reaction. We conclude that there exists a high comparability of the bronchial response to an allergen challenge performed either by a standard method at tidal volume breathing by continuous inhalation of the allergen aerosol or by a dosimeter method of inhalation despite the difference in the total allergen doses inhaled.
Administration, Inhalation↗
Fixed ventilation during tidal volume breathing bronchial challenge may improve repeatability.
Tidal breathing during bronchial challenge shows both between- and within-subject variation. A challenge protocol permitting controlled ventilation was designed in order to improve repeatability of the method. Twenty-five patients were challenged twice with an interval of 2 h. The 2 min ventilation was kept constant at each concentration administered. During the 2 min inhalation of aerosol all expired air (VE) was led through a dry gas meter and respiratory frequency was counted concomitantly. The patients were instructed to achieve the same 2 min ventilation at each dosage. All patients accomplished the two challenges without problems. A PC20 was determined by interpolation on the log dose-response curve. Repeatability was improved compared to what has been found in previous studies on adults, although statistically non-significant when compared to one study. The 95% confidence interval for PC20 based on a single determination was rather narrow, being the observed value +/- 0.58 two-fold concentration differences.
Adult↗