RATIONALE: Chronic conditions, including allergic rhinitis (AR), may result in significant sleep perturbations that can lead to further worsening of symptoms and performance. To further evaluate the patient perception of the AR impact on sleep disturbances, a national survey was conducted. METHODS: The NASL 2010 national survey was comprised of 3 separate surveys in adults (>18 yrs); results obtained from the cross-sectional component (respondents with or without AR) and impact of AR component (respondents with AR) are presented herein. RESULTS: In the cross-sectional survey (N=522), 116 (22.2%) respondents reported having AR. In the cross-sectional analysis, 29% of respondents with AR reported having sleep disturbances. More specifically, respondents with AR compared to those without AR, reported more difficulty getting to sleep (24% vs 8%), waking up during the night (31% vs 13%), and an overall lack of a good night's sleep (26% vs 11%), respectively. In the impact of AR survey (N=400) similar results were reported. Respondents with AR were “extremely,” "moderately," or “somewhat” troubled by their difficulty getting to sleep (34%), waking up during the night (38%), and lack of a good night's sleep (42%) because of their nasal symptoms. During the worst month of allergy symptoms, respondents stated that they were “frequently” or “sometimes” tired (85%), irritable (67%), or miserable (60%). CONCLUSIONS: Results from this survey further highlight sleep disturbance as one of the major burdens resulting from AR. Thus, there is still a need for new effective treatment options that reduce nasal symptoms and improve sleep quality in patients with AR.

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.

Cromolyn sodium (Intal) has been available in the United States to treat asthma for more than 30 years. Its clinical efficacy in patients with mild or moderate persistent asthma is well documented, and its extensive clinical record of safety remains unique among antiasthma medications. The history of cromolyn sodium complements the science behind current understanding of asthma pathophysiology. Cromolyn sodium was the first nonsteroid, antiasthma drug that blocked chemical mediator release at the cellular level. However, the younger generation of health care providers may not be familiar with the medication due to the plethora of antiasthma agents that have recently become available. This review reexamines the role of cromolyn sodium (now available as an HFA aerosol) in the treatment of asthma.

OBJECTIVE:The objective of our study was to compare the efficacy and safety of fluticasone propionate (an inhaled corticosteroid) with zafirlukast (a leukotriene modifier) for persistent asthma.STUDY DESIGN:In this randomized placebo-controlled, parallel-group, double-blind, double-dummy trial, patients underwent an 8- to 14-day run-in period followed by 12 weeks of treatment with inhaled fluticasone propionate (88 mg twice daily by metered-dose inhaler), oral zafirlukast (20 mg twice daily), or placebo.POPULATION:We included a total of 338 persistent asthma patients, 12 years of age or older, using short-acting b2-agonists alone.OUTCOMES:measured Efficacy outcomes included changes in pulmonary function, asthma symptoms, rescue albuterol use, nighttime awakenings due to asthma, and quality of life. Safety outcomes included asthma exacerbations, adverse events, and clinically significant laboratory test results.RESULTS:After 12 weeks of treatment, patients taking fluticasone propionate experienced significantly greater improvements in all clinical parameters (symptom scores, percentages of symptom-free and albuterol-free days, albuterol use, and nighttime awakenings) compared with patients taking zafirlukast (P <.05) or placebo (P <.05). Treatment with fluticasone propionate resulted in significantly greater improvements in pulmonary function compared with zafirlukast (P <.05) or placebo (P <.05). Fewer fluticasone propionate patients (4%) had an exacerbation requiring oral corticosteroids compared with those taking zafirlukast (12%) or placebo (10%).CONCLUSIONS:Inhaled fluticasone propionate is more effective than zafirlukast in controlling asthma symptoms, improving pulmonary function, and improving quality of life for patients who are symptomatic with the use of short-acting b2-agonists alone.

Objective Montelukast is a leukotriene receptor antagonist administered orally once daily for treatment of chronic asthma in adults and children. A comprehensive analysis of safety data from double‐blind, randomized, placebo‐controlled trials with montelukast has not been previously reported. Patients and methods A pooled analysis of safety data from 11 multicentre, randomized, controlled montelukast Phase IIb and III trials and five long‐term extension studies was performed. A total of 3386 adult patients (aged 15–85 years) and 336 paediatric patients (aged 6–14 years) were enrolled in the trials; 2031 adults received montelukast for up to 4.1 years, and 257 children received montelukast for up to 1.8 years. Summary statistics comparing incidences of adverse events among treatment groups were calculated. Results The overall incidence of clinical and laboratory adverse events among montelukast‐treated patients, both adult and paediatric, was similar to that among patients receiving placebo. There were no clinically relevant differences in individual adverse events, including infectious upper respiratory conditions and transaminase elevations, between montelukast and placebo groups. Discontinuations due to adverse events occurred with similar frequencies during placebo, montelukast and inhaled beclomethasone therapy. No dose‐related adverse effects of montelukast were observed in adults treated with dosages as high as 200 mg per day (20 times the recommended dose) for 5 months. This tolerability profile montelukast observed in clinical trials has been generally reflected in the post‐marketing safety experience seen to date. Conclusion These data indicate a tolerability profile for montelukast similar to placebo during both short‐term and long‐term administration, even at doses substantially higher than the recommended clinical dose of 10 mg once daily for adults and 5 mg once daily for children aged 6–14 years.

Two multicenter, randomized, doublemasked, placebo-controlled, parallel-group studies were conducted in adult patients with mild-to-moderate persistent asthma to assess the effects of 4 weeks of treatment with inhaled corticosteroids on hypothalamic-pituitary-adrenal (HPA) axis function. The first study compared fluticasone propionate 100 and 500 μg twice daily, triamcinolone acetonide 300 and 500 μg twice daily, oral prednisone 10 mg every morning, and placebo. The second study compared fluticasone propionate 100 and 250 μg twice daily, flunisolide 500 μg twice daily, and placebo. Therapeutic doses of fluticasone propionate, triamcinolone acetonide, and flunisolide were found to be comparable to each other and to placebo in their lack of adrenal suppressive effects, based on mean plasma cortisol responses to 6-hour cosyntropin infusion. Prednisone produced significantly greater suppression of HPA-axis function than did any of the inhaled corticosteroids or placebo (P < 0.001). Mean reductions from baseline in 8-hour area under the plasma concentration-time curve (AUC) and 8-hour peak plasma cortisol concentrations and the mean percentage of change from baseline in 8-hour AUC were significantly greater after treatment with triamcinolone acetonide 500 μg twice daily compared with placebo (P < 0.042). These findings indicate that fluticasone propionate has no greater systemic effect than either triamcinolone acetonide or flunisolide at doses appropriate for patients with mild-to-moderate persistent asthma.

Background: Perennial rhinitis is a common condition that affects up to 10% to 20% of the population. Multiple agents an frequently administered since no single agent provides complete relief. Studies assessing the benefit/risk of combined therapy are important especially for newly approved agents such as ipratropium bromide nasal spray 0.03%, a topical anticholinergic agent, approved specifically for the treatment of rhinorrhea in allergic and non-allergic perennial rhinitis,Objective: To compare the efficacy and safety of the combined use of ipratropium bromide nasal spray 0.03% (42 mu g per nostril tid) and beclomethasone dipropionate nasal spray (84 mu g per nostril bid) against that of either active agent alone for the treatment of rhinorrhea.Design: Multicenter, 6-week, double-blind, randomized active- and placebo-controlled, parallel trial.Setting: Allergist and general practitioner clinical practices.Patients: Five hundred thirty-three patients with perennial rhinitis (279 allergic and 274 non-allergic), 8 to 75 years of age, who had at least a mild degree of severity of rhinorrhea for a minimum of 2 hours per day during the I week screening period as well as congestion or sneezing also of at least mild severity.Intervention: Either (1) ipratropium bromide nasal spray 0.03% (42 mu g per nostril tid) plus beclomethasone dipropionate nasal spray (84 mu g per nostril bid), (2) ipratropium bromide nasal spray 0.03% (42 mu g per nostril tid) alone, (3) beclomethasone dipropionate nasal spray (84 mu g per nostril bid) alone, or (4) vehicle [matching placebo nasal spray for the ipratropium bromide (2 sprays per nostril tid)] or beclomethasone dipropionate (2 sprays per nostril bid).Main Outcome Measure: Severity and duration of rhinorrhea, and patient and physician global assessment of control of rhinorrhea. Results: Ipratropium bromide nasal spray plus beclomethasone nasal spray was more effective than either active agent alone or vehicle in reducing the average severity and duration of rhinorrhea during 4 weeks of treatment. The advantage of ipratropium bromide plus beclomethasone nasal spray was evident by the first day of combined treatment and continued throughout the 2-week treatment period. Ipratropium bromide nasal spray had a faster onset of action during the first week of treatment and reduced the duration of rhinorrhea more than beclomethasone. Beclomethasone nasal spray was more effective in reducing the severity of congestion and sneezing than ipratropium. Tn patients who had not responded well to a nasal steroid prior to participation in the study based on a questionnaire administered at screening, ipratropium bromide was as effective in the steroid non-responders as steroid responders, whereas beclomethasone was more effective in steroid responders. Combined active therapy was well tolerated with no increase in adverse events over that seen previously with ipratropium bromide or beclomethasone nasal spray alone.Conclusions: The combined use of ipratropium bromide nasal spray with beclomethasone dipropionate nasal spray is more effective than either active agent for treatment of rhinorrhea, and does not result in a potentiation of adverse drug reactions. Ipratropium bromide nasal spray 0.03% alone should be considered in patients for whom rhinorrhea is the primary symptom, and its use in combination with a nasal steroid should be considered in patients where rhinorrhea is one of the predominant symptoms, or in patients with rhinorrhea not fully responsive to other therapy.

A self-administered screening questionnaire was sent to 15,000 households randomly selected from a nationwide panel of approximately 200,000 households. This questionnaire was used to select a balanced sample of 1450 persons with greater than or equal to 7 days of nasal/ocular symptoms in the previous 12 months. These persons received a second questionnaire that contained detailed questions regarding symptoms, triggers, patient attitudes, and medical treatment. Of the 1065 people who responded to the second questionnaire, 481 were identified as having self-reported seasonal or perennial allergic rhinitis. Our major findings regarding the attitudes toward their disease expressed by these 481 respondents are as follows. Although 53% of our study population regarded their symptoms as mild, 47% reported onset before age 17, suggesting that many have become accustomed to their symptoms. The level of allergen avoidance was generally low; only 38% took any allergen avoidance measures in the home. The level of self-medication was high; 92% reported self-medication with prescription and nonprescription drugs. Finally, 26% believed that their symptoms were ''well controlled'' or ''completely controlled,'' and 52% believed that effective treatments were available. Our findings suggest the need for a greater effort on the part of health care providers to identify patients with allergic rhinitis and to educate them about their disease.

Background: H-1-receptor antagonists are effective for the treatment of seasonal allergic rhinitis. In rare circumstances, some second-generation H-1-receptor antagonists have been associated with prolongation of the corrected QT interval (QT(c)), thus increasing the risk of ventricular arrhythmias. Fexofenadine 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 less than or equal to .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 QT,, 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.

The study objective was to examine the current national prevalence of allergic rhinitis by gender, age, geographic region, population density (urban/rural), and household income. A self-administered questionnaire was sent to 15,000 households representative of the U.S. population in respect to these factors. The household member who knew the most about the family's health status and health history in the previous 12 months was asked to estimate the number of days during which household members had experienced sneezing, runny nose, stuffy nose or head, itchy eyes, or watery eyes. They were also asked about physician diagnosis of hay fever, rhinitis, persistent stuffy nose or head, or allergies involving the eyes, nose, or throat. The 9946 households responding (66.3%) represented 22,285 persons, 8394 of whom had experienced the symptoms described. In a follow-up questionnaire sent to a balanced sample of 1450 responders (>90% white, slightly more females than males), subjects were asked to indicate which of the following best described their symptoms: a common cold; a seasonal allergy (i.e., hay fever); an allergy I have all the time; an allergy only when exposed to triggers (i.e., dust, pollution); or sinus problems. Of the 1065 subjects (73.4%) responding, 31.5% reported greater than or equal to 7 days of nasal/ocular symptoms, and 17.7% reported greater than or equal to 31 days of symptoms. Physician-diagnosed hay fever was reported by 8.2% and allergic rhinitis (seasonal plus perennial) by 14.2%. Prevalence was highest among those age 18 to 34 years and 35 to 49 years, decreasing after age 50 years. No major trends were evident,vith regard to other variables studied. Extrapolation based on 1993 census data suggests that at least 35.9 million persons have symptoms associated with allergic rhinitis and up to 79.5 million persons experience greater than or equal to 7 days of nasal/ocular symptoms yearly.

Health care delivery is increasingly driven by results of outcomes studies.The best single instrument or combination of instruments for measurement of outcome in patients with symptoms of rhinitis has not been determined.The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), a generic instrument, and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), a disease-specific instrument, have both been used.We carried out a population-based study in 312 subjects with nasal/ocular symptoms who filled out both questionnaires.We then compared their responses with those of healthy controls.Statistically significant differences between patients and controls were observed in seven of nine dimensions in the SF-36 questionnaire and in all of the seven dimensions and the aggregate score of the RQLQ.In all cases, the direction of the changes in health status indicated impairment of quality of life, particularly in ability to perform normal physical roles.Patients were troubled by repeated nose blowing, had a disrupted sleep pattern, were fatigued, and had a reduced ability to concentrate.We conclude that these outcomes should be incorporated into clinical trials, effectiveness research, and therapeutic strategies.(

Allergic rhinitis is the most common chronic allergic disease. Symptoms include continuous or periodic nasal congestion, rhinorrhea, sneezing, itching of the nose and eyes, generalized malaise, irritability, and fatigue. We conducted an evaluation of the costs related to management of allergic rhinitis in a U.S. population. Data are based on self-reported trends in medication and health care services usage from a nationwide population sample selected from a base of 15,000 households. The average per-patient expenditure for prescription medications was $56 yearly. The mean per-patient expenditure for nonprescription medications was $56 yearly. Based on the findings of this study, the estimated total annual medication cost associated with allergic rhinitis in the United States is $2.4 billion. Because 63% of our study population had consulted a physician within the last 12 months, we estimate that a further $1.1 billion is associated with physician billing. The cost of the comorbid conditions of asthma and sinusitis originating from or exacerbated by allergic rhinitis could significantly alter these figures. If management of these conditions were allowed to contribute, even in part, to the indirect cost, the financial impact of this disease would be more properly appreciated.