Does using a mouthwash instead of water improve the oropharyngeal removal of inhaled flovent (fluticasone propionate)?

Rinsing the mouth with water is recommended to remove inhaled corticosteroid (ICS) deposited on the oropharyngeal mucosa. Given the lipophilicity of fluticasone propionate (FP), an ethanol-based mouthwash was hypothesized to be superior to water. This study's purpose was to compare the effectiveness of water versus Listerine (Warner Lambert, Lititz, PA) in removing FP from the oropharyngeal mucosa. Asthma patients were randomly assigned water or a Listerine-rinsing vehicle. A 440-microgram dose of FP was inhaled. After the second puff, patients rinsed for 30 seconds with 20 mL of the assigned agent and then repeated the process, spitting each "wash" into the same cup. At visit 2, patients used the alternate vehicle and repeated the procedure. Samples were frozen until analyzed using liquid chromatography/mass spectrophotometry (lower limit of detection 0.067 microgram/mL). Thirty-six patients (mean age, 44 years; 66% female) participated. Mean inhaler technique score was 11.3 (scale of 1-12). Eighty-three percent used the closed-mouth technique. The mean concentration of FP removed by Listerine was not statistically different than that removed by water, 1.67 micrograms/mL (range, 0.067-4.195 micrograms/mL) and 1.42 micrograms/mL (range, 0.067-5.107 micrograms/mL), respectively, and the total milliliter returned was assumed to be 40 mL. Regression analysis using sex, age, and inhaler technique showed no statistical relationship with the amount of FP removed. Therefore, Listerine was not more effective than water in removing FP from the oropharyngeal mucosa (p = 0.53). Thus, water is an adequate rinsing vehicle for removal of ICS deposited on the oropharyngeal mucosa. Other factors besides the rinsing vehicle are strong factors in determining the amount of drug removed.

Effect of 60 mg twice-daily fexofenadine HCl on quality of life, work and classroom productivity, and regular activity in patients with chronic idiopathic urticaria.

The effect of 60 mg twice-daily fexofenadine HCl on health-related quality of life and productivity at work, in the classroom, and during daily activities in patients with moderate to severe chronic idiopathic urticaria symptoms was studied in two identical, 4-week, placebo-controlled, multicenter clinical trials. Patients self-administered the Dermatology Life Quality Index (score, 0-30) and the Work Productivity and Activity Impairment instrument (0%-100%). In both trials, improvements in Dermatology Life Quality Index scores in fexofenadine-treated patients (N = 169) were statistically significant compared with placebo (P < or =.0002). Similarly, improvements in productivity scores with fexofenadine 60 mg twice daily were statistically superior to placebo at work (n = 120, P < or =.0152) and in performance of daily activities (n = 166, P < or =.0002). There was a trend toward improved classroom productivity (n = 26) with fexofenadine. We conclude fexofenadine 60 mg twice daily improves health-related quality of life, increases work productivity, and improves performance of daily activities in patients with moderate to severe chronic idiopathic urticaria.

Allergic rhinitis: epidemiology and natural history.

Establishing a reliable estimate of the prevalence of allergic rhinitis is difficult; prevalence estimates range from as low as 4% to more than 40%. Epidemiology studies suggest the prevalence of allergic rhinitis in the United States and around the world is increasing. The cause of this increase is unknown; however, contributing factors may include higher concentrations of airborne pollution, rising dust mite populations, less ventilation in homes and offices, dietary factors, and the trend toward more sedentary lifestyles. Allergic rhinitis symptoms typically begin in childhood and adolescence and continue into adulthood. In general, allergic rhinitis symptoms slowly improve and skin-test reactivity tends to wane with increasing age. There is a significant trend for symptom improvement with younger age of onset of allergic rhinitis. As the complicated etiology of allergic rhinitis becomes better understood, it may be possible to reverse the trend for increased prevalence.

Efficacy and safety of fexofenadine hydrochloride for treatment of seasonal allergic rhinitis.

BACKGROUND: H1-receptor antagonists are effective for the treatment of seasonal allergic rhinitis. In rare circumstances, some second-generation H1-receptor antagonists have been associated with prolongation of the corrected QT interval (QTc), thus increasing the risk of ventricular arrhythmias. Fexofendine HCl, the carboxylic acid metabolite of terfenadine, is a new second-generation antihistamine that is nonsedating and does not cause electrocardiographic effects. OBJECTIVE: To investigate the clinical efficacy and safety of fexofenadine HCl in the treatment of ragweed seasonal allergic rhinitis and to characterize the dose-response relationship of fexofenadine HCl at dosages of 60, 120, and 240 mg bid. METHODS: A multicenter, 14-day, placebo-controlled, double-blind trial was conducted with patients suffering from moderate to severe ragweed seasonal allergic rhinitis who met symptom severity criteria after a 3-day placebo baseline period. Patients with minimal or very severe symptoms during the baseline period were excluded. Patients were randomized to receive fexofenadine HCl (60, 120, or 240 mg bid) or placebo at 12-hour dosing intervals (7:00 AM and 7:00 PM). The primary efficacy measure was patient-assessed 12-hour reflective total symptom score before the evening dose (trough). RESULTS: Five hundred seventy patients completed the trial. Fexofenadine HCl at each dosage provided significant improvement in total symptom score (P < or = .003) and in all individual nasal symptoms compared with placebo. The frequency of adverse events was similar among fexofenadine HCl and placebo groups, with no dose-related trends. No sedative effects or electrocardiographic abnormalities, including prolongations in QTc were detected. CONCLUSIONS: Fexofenadine HCl is both effective and safe for the treatment of ragweed seasonal allergic rhinitis. Because there was no additional efficacy at higher dosages, 60 mg bid appears to be the optimal therapeutic dosage for these patients.

Impact of fluticasone propionate powder on health-related quality of life in patients with moderate asthma.

Because biological indicators alone do not adequately represent the comprehensive health status of a patient with asthma, we also assessed patients' health-related quality of life (HRQOL) in a randomized, double-blind, placebo-controlled study of the effects of the inhaled corticosteroid fluticasone propionate (FP). A total of 342 patients with moderate asthma were treated twice daily for 12 weeks with FP powder (50, 100, or 250 micrograms) or placebo. At regular intervals, patients completed the Medical Outcomes Study Short Form-36, acute version (SF-36A), a general health status questionnaire measuring eight dimensions of HRQOL; the 20-item Living with Asthma (LWA-20) questionnaire, a disease-specific instrument measuring HRQOL; and three additional questions related to sleep loss and number of nighttime awakenings. Each of the three FP groups compared with placebo had significantly higher scores at study endpoint on the Physical Functioning (p < 0.001) and Role-Physical (p < or = 0.0001) dimensions of the SF-36A; the FP 100- or 250-micrograms groups compared with placebo also had significantly higher scores on General Health Perceptions (p < 0.03), Vitality (p < 0.007), and Mental Health (p < 0.02). At endpoint, all three FP groups compared with placebo had significantly better scores on the LWA questionnaire (p < 0.05) and on the sleep-related items (p < 0.0001). These data, collected using both a general health status questionnaire and an asthma-specific questionnaire, demonstrate that fluticasone propionate powder can improve HRQOL in patients with mild-to-moderate asthma.

Epidemic of asthma in a wood products plant using methylene diphenyl diisocyanate.

Eighteen employees with lower respiratory symptoms later confirmed to be occupational asthma were referred for evaluation. All were employees of a single wood products plant using heated methylene diphenyl diisocyanate (MDI) in the manufacture of a synthetic wood product. Of the 18, 15 had no prior airway symptoms or other known bronchial injury, and 16 had positive methacholine bronchial provocation tests. All cases occurred during a 2.5-year period after exposure to a new manufacturing process using steam-heated MDI resin in a new manufacturing facility. Initially, employees developed symptoms related to the start-up process in the plant, with possible higher MDI exposures and probable higher resin temperatures. Later, most employees who developed new symptoms worked in areas of the plant where they were exposed mostly to heated boards. This suggests MDI sensitization arising at lower temperatures than previously considered likely for this substance.

Safe allergen immunotherapy. The correct allergen, the appropriate patient, the adequate dose.

Effective immunotherapy has been shown to be allergen-specific, dose-dependent, and duration-dependent. Patients must receive adequate doses of the relevant allergen to obtain benefit, and most require 3 to 5 years of injections to maintain prolonged benefit after injections are stopped. Concurrently, patients must cooperate by modifying their environment and using some medications during difficult seasons. Although serious reactions to immunotherapy are relatively rare, a physician must be readily available whenever injections are administered, and office staff need to recognize and be ready to respond to systemic reactions.

A 12-week dose-ranging study of fluticasone propionate powder in the treatment of asthma.

Fluticasone propionate (FP) administered via metered-dose inhaler is a potent corticosteroid effective in the treatment of asthma. To evaluate the efficacy and safety of FP powder administered via a breath-activated inhaler (Diskhaler), a multicenter, double-blind, randomized, placebo-controlled, parallel-group study was conducted in adolescent and adult patients (n = 331) with mild-to-moderate asthma previously treated with beta 2-agonist therapy alone. Patients received FP powder 50, 100, or 250 micrograms or placebo twice daily for 12 weeks. FP-treated patients compared with placebo-treated patients had significantly (p < 0.001) greater improvements in morning predose forced expiratory volume in 1 sec (21-22% increase vs. 9%). Improvement in morning peak flow rate were also significantly (p < 0.001) greater with FP than with placebo (8-10% increase vs. 2% increase). There was also a significant overall treatment difference in the frequency of inhaled albuterol use (p < 0.001) and number of nighttime awakenings due to asthma (p = 0.005). There were no statistically significant difference among the FP treatment groups in any outcome measure. Physicians' global assessments also indicated significant (p < 0.001) differences in efficacy, with 67-74% of FP-treated patients rated as having "effective" or "very effective" treatment compared with 41% of placebo-treated patients. Significant beneficial effects of FP were observed in lung function and diary card parameters after just 1 week of treatment. Adverse events were similar across treatment groups and primarily related to local irritation. Effect on hypothalamic-pituitary-adrenal axis function was minimal. In summary, all three dosages of inhaled FP powder were well tolerated and improved various asthma-related variables. Improvements in pulmonary function, beyond those achieved with beta 2-agonist therapy alone, were maintained for the duration of the 12-week study.

Insect sting allergy: analysis of a cohort of patients who initiated venom immunotherapy from 1978 to 1986.

BACKGROUND: The proper duration of venom immunotherapy remains uncertain. OBJECTIVE: We report our experience with a cohort of patients who started venom immunotherapy from 1978 to 1986. METHODS: In a midwestern allergy practice, the cohort of 204 stinging insect-allergic patients who commenced venom immunotherapy from 1978 to 1986 were identified and evaluated by retrospective chart analysis and patient telephone inquiry. RESULTS: Only 12 patients remain on venom treatment. The majority of patients have discontinued venom immunotherapy either by self-determination (35 patients) or upon physician advice (80 patients). There was no relationship between the severity of the initial sting reaction and the length of time patients received therapy. After cessation of venom treatment, there were 148 re-stings in 117 patients with only two re-sting reactions, both of which occurred in patients with severe initial sting reactions. CONCLUSIONS: Most patients who have received four to 6 years of venom immunotherapy continue to tolerate insect stings after cessation of treatment.

A comparative tolerance study of terfenadine-pseudoephedrine combination tablets and pseudoephedrine tablets in patients with allergic or vasomotor rhinitis.

In this multicentre, double-blind, randomized, parallel group study, 315 patients with allergic or vasomotor rhinitis were treated on a twice daily dosing schedule with either a 60 mg terfenadine-120 mg pseudoephedrine hydrochloride combination or 120 mg pseudoephedrine hydrochloride (extended release) for 2 weeks. No clinically significant differences between the two groups were noted in body weight, temperature, respiration rate or blood pressure following the treatment period. An increase in mean heart rate of approximately 5 beats/min from entry to the final clinic visit was noted in both treatment groups. No clinically significant changes were noted in either treatment group when pre- and post-treatment electrocardiograms were compared. There were also no clinically significant alterations in laboratory values, which included serum chemistry, haematology and urinalysis, within or between either group. The adverse events profiles for both groups were similar. The most frequent adverse event was insomnia, in 40 (25.3%) patients given the terfenadine-pseudoephedrine combination and in 42 (26.8%) of those given pseudoephedrine. No unusual or unexpected adverse events were reported.

Double-blind comparison of terfenadine, chlorpheniramine, and placebo in the treatment of chronic idiopathic urticaria.

The efficacy of terfenadine, a nonsedating H1 antihistamine, in the management of chronic idiopathic urticaria was compared with chlorpheniramine and placebo in a parallel multicenter trial. Subjects with symptoms of hives for 3 days per week for at least 6 weeks were initially screened and admitted if no identifiable cause for symptoms could be determined. Patients entered a single-blind placebo period, and if hives of moderate severity were present for at least 3 days during the week, they were randomly assigned in a double-blind fashion to take terfenadine, 60 mg twice daily, chlorpheniramine, 4 mg three times a day, or placebo for 6 weeks. Data were analyzed for 122 patients. Those patients receiving both active treatments noted significant improvement in symptoms: pruritus, redness, number of hives, and waking hours during which hives were present, at the end of the first day of therapy. Symptom control by terfenadine was statistically superior to placebo during all 6 weeks, as rated by both patients and investigators. However, statistical significance was not achieved for chlorpheniramine at all observation points. Diphenhydramine was permitted as a relief medication for refractory symptoms and was taken by 52% of subjects receiving placebo, 26% taking chlorpheniramine, and only 9% of patients who were receiving terfenadine. In addition to providing superior symptom control, terfenadine caused less drowsiness and fatigue than chlorpheniramine. Terfenadine is a useful therapeutic agent for primary management of chronic idiopathic urticaria.

Asthma from psyllium in laxative manufacture.

Symptoms of asthma developed in three patients after exposure to psyllium powder, which was being used in the manufacture of a bulk laxative. All three had reaginic skin test sensitivity, and two had positive bronchial challenges with a psyllium extract.