RATIONALE: This study used two questionnaires to examine quality of life (QoL) during allergy season in allergic rhinitis patients on concomitant systemic and/or nasal therapy. The impact of the addition of a topical ocular anti-allergic (olopatadine HCl 0.1% ophthalmic solution) to concomitant anti-allergic therapy was evaluated. METHODS: This was a 4-week, multi-center, prospective, open-label, cross-over QoL environmental study. Diagnosed rhinitis patients currently on systemic and/or topical nasal therapy and with no prior diagnosis of allergic conjunctivitis or usage of prescription ocular allergic therapy were enrolled. Patients attended three office visits and were asked to complete two QoL questionnaires (RQLQ and ACQLQ) at each visit. Patients continued their prescribed rhinitis treatment regimen throughout the trial. RESULTS: 200 patients completed this study. At baseline these patients had global scores of RQLQ: 2.16 and ACQLQ: 2.15. The number of days during the previous week that patients experienced eye allergy symptoms was 3.92. Following the addition of ocular treatment, clinically relevant and statistically significant improvement was seen in nasal and ocular global scores (RQLQ: -1.00, ACQLQ:-1.19(p<0.01)). Clinical significance was defined as 0.5 score improvement on a 6.0 scale. On average, patients experienced 2.2 fewer days with ocular allergic symptoms. These results were consistent across concomitant rhinitis treatment groups. CONCLUSIONS: QoL, as measured by both nasal and ocular domains, was improved following addition of topical ocular anti-allergic therapy to concomitant rhinitis therapy. These data suggest that opportunity exists to improve QoL in patients without prior allergic conjunctivitis diagnosis or use of prescription ocular allergic therapy.

Background: Allergic rhinoconjunctivitis patients are often treated with nasal or systemic allergy therapy, forgoing therapy for ocular symptoms. This treatment regimen leaves important aspects of the allergic reaction untreated and affects quality of life (QoL). The Rhinoconjunctivitis Quality of Life Questionnaire and the Allergic Conjunctivitis Quality of Life Questionnaire quantify separate aspects of QoL.Objective: To determine the benefit gained in QoL, measured by these questionnaires, when antiallergy eyedrops (olopatadine) were added to patients' preexisting regimens of nasal or systemic allergic rhinitis treatment.Methods: This was a 4-week prospective, multicenter, open-label, crossover, environmental QoL study. Visit 1 randomized patients to treatment group A or B and included baseline examinations and questionnaires. Group A instilled olopatadine twice daily and concomitantly with previously prescribed nasal or systemic antiallergy medication for 2 weeks. Group B received no ocular therapy and used only previously prescribed antiallergy medication for 2 weeks. Treatment group crossover occurred at visit 2. Patients again completed the questionnaires at visits 2 and 3.Results: Two hundred patients completed the study, 97 in group A and 103 in group B. Groups A and B experienced ocular allergic symptoms for 3.88 and 3.96 days, respectively, during the week before baseline. At visits 2 and 3, questionnaire scores were significantly improved for each group when olopatadine was added compared with the nontreatment periods. By visit 2, olopatadine improved QoL by 49% compared with 5% in the nontreated group (P < .001).Conclusions: In this study, 90.5% of patients with allergic rhinitis treated nasally or systemically also had ocular allergic symptoms. Adding olopatadine to these patients' medication regimens significantly improved ocular allergic symptoms and overall QoL.

RATIONALE:The Breathmobile® program was developed to improve children's health status and quality of life by providing specialty care to asthmatic children at their local schools.The demographics and outcomes of a program specially designed to treat inner-city asthmatic children in Orange County, CA have never been reported.METHODS: Since April 2002, more than 235 children were evaluated for asthma by the Breathmobile®.Analysis included evaluation of medical history, physical exam, spirometry testing, skin testing, and physician diagnosis of asthma according to the NHLBI guidelines.RESULTS: Analysis of 235 asthmatic patients showed a population of 57% males/43% females, mean age of 8 years, and 75% Hispanic/Latino.Of these asthmatics, 30% had intermittent and 70% persistent disease.Skin testing showed the highest sensitivity rate to dust mite (23% in intermittent and 31% in persistent asthma), with cockroach second (13% in intermittent and 13% in persistent asthma).Of these children in the past year, 54% had missed school due to asthma symptoms (13% having missed more than 10 days), 27% had visited the ER (15% more than two times), and 10% had been hospitalized.On initial evaluation, 29% of asthmatics were on controller medications, which increased to 70% by the first follow-up visit.Asthma symptoms (cough, chest tightness, wheezing, dyspnea, and awakenings) decreased from four to one in persistent asthmatics by the first follow-up visit (average 35 days), with ER visits declining to 2%. CONCLUSIONS:The Breathmobile® provides valuable access and improved outcomes in the care of inner-city asthmatic children.

Background: Both inhaled corticosteroids and leukotriene modifiers are used in the maintenance treatment of persistent asthma. Objective: The goal was to compare the efficacy and safety of low-dose fluticasone propionate (FP) and montelukast as first-line maintenance therapy in symptomatic patients by using short-acting β2-agonists alone to treat persistent asthma. Methods: In this multicenter, randomized, double-blind, double-dummy, parallel-group study, 533 patients (>15 years old) with persistent asthma who remained symptomatic while taking short-acting β2-agonists alone were treated with FP (88 μg [2 puffs of 44 μg] twice daily) or montelukast (10 mg once daily) for 24 weeks. Results: Compared with treatment with montelukast, treatment with FP resulted in significantly greater improvements at endpoint in morning predose FEV1 (22.9% vs 14.5%, P < .001), forced midexpiratory flow (0.66 vs 0.41 L/sec, P < .001), forced vital capacity (0.42 vs 0.29 L, P = .002), morning peak expiratory flow (PEF) (68.5 vs 34.1 L/min, P < .001), and evening PEF (53.9 vs 28.7 L/min, P < .001). Similar improvements in PEF were observed in patients with milder asthma (>70%-80% predicted FEV1). At endpoint, FP was more effective than montelukast at decreasing rescue albuterol use (3.1 puffs/day vs 2.3 puffs/day, P < .001), asthma symptom scores (–0.85 [48.6% decrease] vs –0.60 [30.5%], P < .001), and nighttime awakenings due to asthma (–0.64 awakenings/night [62% decrease] vs –0.48 awakenings/night [47.5%], P = .023), and FP increased the percentage of symptom-free days (32.0% vs 18.4% of days, P < .001) compared with montelukast. The adverse event and asthma exacerbation profiles for FP and montelukast were similar. Conclusions: Low-dose FP is more effective than montelukast as first-line maintenance therapy for patients with persistent asthma who are undertreated and remain symptomatic while taking short-acting β2-agonists alone. (J Allergy Clin Immunol 2001;107:461-8.)

STUDY OBJECTIVES This study investigates the long-term cardiovascular safety of salmeterol powder vs placebo in adolescent and adult patients with mild persistent asthma. DESIGN Multicenter, randomized, double-blind, placebo-controlled, parallel-group study. SETTING Eighteen US clinical centers. PATIENTS Three hundred fifty-two patients (> or = 12 years) with mild persistent asthma (duration > or = 6 months) requiring pharmacotherapy; with FEV1 of 70 to 90% of predicted and without abnormal ECG/continuous ambulatory ECG (Holter). INTERVENTIONS Randomized to twice-daily salmeterol powder (50 microg) or placebo via breath-actuated device for 52 weeks. Backup albuterol was available to control asthma symptoms. MEASUREMENTS AND RESULTS Cardiovascular safety was regularly assessed by 12-lead ECG with a 15-s lead II rhythm strip, 24-h continuous ambulatory ECG (Holter) monitoring, serial vital sign measurements, and review of adverse cardiovascular events. No deaths occurred during the study. No clinically significant between-group differences were observed in pulse rate, ECG QTc interval, median number of ventricular or supraventricular ectopic events, incidence of ventricular ectopic couplets and runs, or incidence of > 100 ventricular or supraventricular ectopic events in 24 h. No clinically significant between-group differences were observed in arterial BP or incidence of adverse cardiovascular events. Salmeterol was well tolerated throughout the 52-week study period, with a cardiovascular safety profile similar to that of placebo. CONCLUSIONS Long-term, twice-daily pharmacotherapy with salmeterol powder is safe and is not associated with unfavorable clinically significant changes in cardiac function or increases in cardiovascular adverse effects.

A double‐blind, randomized, placebo‐controlled, parallel‐group, multicenter study was conducted to compare the effectiveness of an extended‐release formulation of a classical antihistamine, brompheniramine, and a second‐generation compound, loratadine, in the treatment of allergic rhinitis. Subjects with symptoms of allergic rhinitis received brompheniramine 12 mg twice daily (n = 112), loratadine 10 mg once daily (n = 112), or placebo twice daily (n = 114) for 7 days. Study medications were blinded using a double‐dummy technique. Subjects completed an overall evaluation of symptom relief on a daily basis and returned on treatment days 3 and 7, at which times the investigator assessed symptom severity. The investigator and subject each completed a global efficacy evaluation, and subjects were interviewed regarding adverse experiences. The primary efficacy variable was the physicians' global efficacy evaluation on day 3. Symptoms also were analyzed as summed severity scores for all symptoms and for the nasal symptom cluster of rhinorrhea, sneezing, and nasal blockage. At all post‐baseline evaluations (days 3, 7, and averaged over the two days), brompheniramine was significantly better than loratadine and placebo for both sets of summed symptom scores and all three global assessments. Loratadine was significantly better than placebo for physician ratings of total symptom severity averaged over the two days and for the physician and subject ratings of the nasal cluster on day 3. Central nervous system‐related symptoms were the most frequently reported adverse experiences; somnolence was reported most frequently by patients taking brompheniramine, and its occurrence was less frequent as treatment continued. A nonprescription, extended‐release formulation of brompheniramine 12 mg twice daily provided significantly better relief of symptomatic allergic rhinitis than loratadine 10 mg once daily.

Background: The number of allergy skin tests required to evaluate patients with respiratory allergy has recently been challenged by the managed care community.Objectives: The purpose of this study was to determine which aeroallergens are prevalent in patients with respiratory allergy (allergic rhinitis and bronchial asthma) in California.Methods: Utilizing aeroallergens thought to be relevant from recent aerobiologic and botanic data, 141 allergic and 17 asymptomatic control subjects were tested for the prevalence of 103 allergens. A standardized prick puncture technique and standardized interpretation of wheal/flare responses were utilized using the same lot of allergen for 13 allergy practices distributed throughout California. Frequency curves based on prevalence were established to determine the number of tests required to give up to 90% of positive responses for tree, weed and grass pollen, mold spores, and miscellaneous allergens which included house dust mite, cat, dog, and cockroach allergens.Results: Positive responses in allergic subjects for grasses ranged from 46% to 54%, for weeds 19% to 37%, and for trees 10% to 42%. For molds the range was from 11% to 22%. The response rate for Dermatophagoides pteronyssinus was 53%, for Dermatophagoides farinae 42%, for cat pelt 39% and cat hair 37%, for cockroach 23% and dog dander 19%. Asymptomatic control subjects responded to only 4% of all allergens tested. Ninety percent of all positive tests required three miscellaneous allergens (house dust mite, cat, and cockroach), 9 molds, 2 grasses, 16 weeds, and 27 trees for a total of 57 allergens (56% of total tested). There was no clear relationship between locale and specific allergen response, probably related to the limited number of subjects tested and variability within the same geographic region. Several seldom tested tree and weed allergens showed a higher prevalence rate than several commonly tested for allergens.Conclusions: This preliminary study suggests that approximately 57 aeroallergens might be adequate to detect 90% of all positive responses in patients with respiratory allergy in California. This study was limited by subject number and variability between study sites. It is hoped a standardized model can be developed from this pilot study to definitively determine which aeroallergens are relevant in the United States.

In an effort to evaluate conformity with published guidelines for diagnostic allergy skin testing in their locality, a committee of members of the Orange County (California) Society of Allergy and Clinical Immunology surveyed their membership for the number, identity, and rates of sensitization of aeroallergens in a selected patient population. Test data were analyzed on patients who were judged appropriate to undergo immunotherapy. Complete test results of 271 patients were obtained from one third of local allergy specialists. A total of 115 different aeroallergen extracts were identified. By category, tree pollen allergens (32) were followed in declining order by weed pollens (28), molds (22), environmentals (18), and grass pollen extracts (15), for the total of 115. The average number of aeroallergens used by a practice in a comprehensive evaluation was 77 (range, 47-114). When only unequivocally positive reactions were considered (3+ equivalent or greater), Bermuda grass pollen extracts elicited the highest rate, 85%, and the environmental, rat dander, was the lowest at 1.8%. At least 20% of the patients reacted strongly on skin tests to 97% of the extracts. The disparity between the recommendations of a maximum of 30 aeroallergens for a comprehensive evaluation and actual practice procedures merits efforts at resolution.