Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: results from a randomised, controlled, double-blind trial.

OBJECTIVE: The investigational AS04-adjuvanted herpes simplex virus type 2 (HSV-2) glycoprotein D (gD2) subunit prophylactic vaccine ('HSV vaccine'; GlaxoSmithKline Vaccines) has been shown to be well tolerated in adults, but limited data exist for pre-teen and adolescent girls, a likely target population. The primary objective of this study was to compare the occurrence of serious adverse events (SAEs) over 12 months between HSV vaccine recipients and saline recipients (placebo control group) in pre-teen and adolescent girls. The immunogenicity of the HSV vaccine was also assessed. METHODS: Healthy girls aged 10-17 years, stratified by age (10-15 years; 16-17 years), were randomised 2:1:1 to receive the HSV vaccine, a hepatitis A vaccine (Havrix™; HAV control) or placebo (saline) according to a 0-, 1-, 6-month schedule. Participants and study personnel not involved in the preparation or administration of vaccines were blinded to treatment. Safety and immunogenicity analyses were performed overall and by age (10-15 years; 16-17 years) and HSV serostatus. RESULTS: No statistically significant difference in the percentage of subjects with SAEs was observed between the HSV and saline group, or between the HSV and pooled control (HAV and saline) groups. The HSV vaccine was well tolerated, although a higher incidence of solicited local symptoms was observed in the HSV group than in the control group. Neither age nor HSV serostatus at the time of study entry had an impact on the safety profile of this vaccine. The HSV vaccine was immunogenic regardless of pre-vaccination HSV serostatus. Higher anti-gD geometric mean concentrations were observed in HSV-1 seropositive participants than in HSV-1 seronegative participants. CONCLUSION: The HSV vaccine had an acceptable safety profile, and was well tolerated and immunogenic when administered to girls aged 10-17 years regardless of age or HSV pre-vaccination serostatus.

Direct-to-participant feedback and awareness of bone mineral density testing results in a population-based sample of mid-aged Canadians.

UNLABELLED: This population-based study of mid-aged Canadians assessed awareness of diagnosis by bone mineral density (BMD) following dual-energy X-ray absorptiometry (DXA) testing and compared the effects of feedback only to the physician with direct-to-participant feedback. Poor recall of osteoporosis results was observed irrespective of the feedback destination, but direct-to-participant feedback improved recall of borderline or normal results. INTRODUCTION: BMD testing provides information about fracture risk. This study assessed whether awareness of results, in a random population sample of mid-aged Canadians, differed if results were provided to physicians only or directly to participants. METHODS: Prospective cohort study of 2,678 women and men aged 40-60 years from the Canadian Multicentre Osteoporosis Study. Participants completed hip and spine DXA and interviewer-administered questionnaires regarding demographics and osteoporosis risk factors. Lateral spine X-rays were conducted on those > or =50 years of age. All test results were reported to the participant, the family physician or both. Associations between BMD results, feedback destination and correct self-report results, 3 years later, were assessed using logistic regression while adjusting for potential confounders. RESULTS: Only 25% of men and 33% of women correctly reported their osteoporosis diagnoses. Direct-to-participant vs. physician-only reports did not improve recall of osteoporosis diagnosis but improved recall of borderline or normal BMD. Older (vs. younger) men and men with prevalent vertebral fractures demonstrated better recall of their osteoporosis diagnosis. CONCLUSIONS: Recall of low BMD results was poor, despite direct-to-participant feedback and even in the presence of other osteoporosis risk factors. Direct-to-participant feedback may improve awareness of borderline or normal BMD results.

An examination of the smoking identities and taxonomies of smoking behaviour of youth.

OBJECTIVE: To address observations that the smoking identities of youth are valid descriptors of their smoking behaviour, we examined the relationships between self-reported smoking identities, perceived levels of addiction, and established taxonomies of smoking behaviour of youth. METHOD: Cross-sectional data were collected on demographics, perceived extent of addiction to tobacco, smoking history, and self-reported smoking identity from questionnaires administered to 8225 students in British Columbia, Canada. A total of 7246 participants were categorised according to four smoking taxonomies established in the literature. Differences in perceived physical and mental addiction between smoking identity groups were calculated. The strength of the associations between the taxonomies of smoking and the smoking identity groups was also assessed. RESULTS: There were significant differences in perceived levels of physical (Kruskal-Wallis chi(2) = 3985.02, p<0.001) and mental (Kruskal-Wallis chi(2) = 4046.09, p<0.001) addiction to tobacco by the participants' self-reported smoking identity. Youth smoking identities were modestly associated with the established smoking taxonomies (Pearson C contingency coefficient = 0.64-0.72). CONCLUSION: Self-reported smoking identities appear to provide valid characterisation of the smoking behaviour of youths that complement and elaborate existing taxonomies of smoking behaviour. Questions about self-reported smoking identity should be used in conjunction with smoking behaviour taxonomies when investigating youth smoking behaviours.

A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ebastine (20 mg and 10 mg) to loratadine 10 mg once daily in the treatment of seasonal allergic rhinitis.

Few randomized studies have compared the H1-receptor antagonists loratadine and ebastine in seasonal allergic rhinitis (SAR) patients. The objective of this study was to compare the efficacy and safety of ebastine 20 mg (E20), ebastine 10 mg (E10), loratadine 10 mg (L10), and placebo (P), once daily, in controlling symptoms of SAR over a 4-week period. This was a double-blind, placebo-controlled, randomized, parallel-group study. Efficacy was assessed in 749 patients (12 to 70 years old) by SAR symptom scores (nasal discharge, congestion, itching, sneezing, and total eye symptoms) entered on diary cards every morning and every evening over the previous 12 hours (reflective score) and at the time of recording (snapshot score). The E20 group showed greater reductions from baseline compared with the L10 group in 2 daily reflective composite scores (nasal index [with or without congestion]) and in all 4 daily snapshot composite scores. E10 and L10 groups showed no significant differences in either the daily reflective or snapshot scores overall although E10 showed a greater improvement of nasal discharge snapshot score than L10. The efficacy of E20 at controlling the symptoms of SAR was well sustained during the fourth week of treatment, with significant differences over placebo in 22/36 total rhinitis symptom scores, followed by E10 (6/36), whereas L10 showed no differences (0/36). Patient and physician global evaluations at the final visit were not statistically significant for any treatment group compared with placebo. There was no significant difference among all groups in the number of patients who reported adverse events. In conclusion, ebastine 20 mg given once daily for 4 weeks in the treatment of SAR showed larger mean reductions from baseline in most rhinitis symptoms scores than loratadine 10 mg. Sustained efficacy was most frequently observed with ebastine 20 mg over placebo, whereas loratadine 10 mg did not provide a statistically significant improvement in any individual or composite symptom score at the end of the fourth week. Both ebastine 20 and 10 mg were well tolerated and proved safe in the treatment of SAR.

Efficacy and safety of ebastine 20 mg compared to loratadine 10 mg once daily in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled study.

BACKGROUND: Few randomized studies have compared loratadine to ebastine in the symptomatic treatment of seasonal allergic rhinitis (SAR) patients. METHODS: This double-blind, placebo-controlled, randomized, parallel-group, comparative trial compared the efficacy and safety of ebastine 20 mg (E20), loratadine 10 mg (L10) and placebo (P), administered once daily, in the control of SAR symptoms over a 2-week period. An additional 2-week treatment period was included in order to check sustained efficacy and tolerability. RESULTS: A total of 703 patients were enrolled: 282 patients in the E20 group, 279 in the L10 group and 142 in the P group. E20 showed a greater decrease from baseline in the main efficacy variable (mean daily reflective total symptom score) than L10 (p = 0.0018) or P (p = 0.0024), whereas the difference between L10 and P was not significant. Moreover, reductions from baseline in all composite/individual daily reflective rhinitis symptom scores were significantly larger in patients receiving E20 than in patients receiving L10 or P. Most significant differences between E20 and L10 or P were maintained after 4 weeks of treatment. Overall, all treatments were safe and well tolerated. There was no significant difference in the percentage of patients who reported one or more adverse events (AEs) between the groups, and most AEs were mild to moderate (89.9%). CONCLUSIONS: E20 given once daily for 2 weeks was more effective in the treatment of SAR symptoms than L10 or P. E20 also showed a sustained efficacy after 4 weeks of treatment, and overall was well tolerated and proved safe.

Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period.

BACKGROUND: Proinflammatory mediators such as the cysteinyl leukotrienes are important in the pathophysiology of allergic rhinitis. This study evaluated the efficacy and tolerability of montelukast, a cysteinyl leukotriene receptor antagonist, given once daily in the morning for treatment of seasonal (fall) allergic rhinitis for 4 weeks. METHODS: This was a randomized, double-blind trial with a placebo run-in and a 4-week treatment period. Patients (n = 1079) with a history of allergic rhinitis and a positive skin test to seasonal pollen allergens were assigned to placebo, montelukast 10 mg, or loratadine 10 mg. Symptoms were assessed with a daily diary. RESULTS: Montelukast was more effective than placebo in improving scores for the primary endpoint of daytime nasal symptoms (P = 0.003) and the secondary endpoints of night-time, composite, and daytime eye symptoms, patient's and physician's global evaluations of allergic rhinitis, and rhinoconjunctivitis quality-of-life (P

Work organization and patient care staff injuries: the impact of different care models for "alternate level of care" patients.

BACKGROUND: The number of elderly patients who do not have acute-care needs has increased in many North American hospitals. These alternate level care (ALC) patients are often cognitively impaired or physically dependent. The physical and psychosocial demands on caregivers may be growing with the increased presence of ALC patients leading to greater risk for injury among staff. METHODS: This prospective cohort study characterized several models for ALC care in four acute-care hospitals in British Columbia, Canada. A cohort of 2,854 patient care staff was identified and followed for 6 months. The association between ALC model of care and type and severity of injury was examined using multinomial and ordinal logistic regression. RESULTS: Regression models demonstrated that the workers on ALC/medical nursing units with "high" ALC patient loads and specialized geriatric assessment units had the greatest risk for injury and the greatest risk for incurring serious injury. Among staff caring for ALC patients, those on dedicated ALC units had the least risk for injury and the least risk for incurring serious injury. CONCLUSIONS: The way in which ALC care is organized in hospitals affects the risk and severity of injuries among patient care staff.

Efficacy of ebastine in the control of nasal congestion associated with allergic rhinitis.

Three similarly designed, multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative studies were carried out in the United States in a total of 1,881 patients to evaluate the efficacy of ebastine 20 mg (E20), ebastine 10 mg (E10), loratadine 10 mg (L10), and placebo (P), all given once daily, in controlling the symptoms of ragweed-induced rhinitis over a 4-week treatment period. Efficacy was assessed, among other means, by nasal congestion symptom scores entered by patients on diary cards in the morning and before bedtime over the previous 12-h period (reflective score, R) and at the time of recording (snapshot score, SS). Mean value of both morning and evening score changes from baseline were analyzed in each study and for each treatment. E20 was more effective than placebo in all studies, in both R and SS symptom scores (6 of 6 scores), while E10 was effective in 4 of 6 scores (2 R and 2 SS). In contrast, L10 was effective in only 1 of 6 scores (1 R). In conclusion, the comparative analysis of the results from these three trials shows that ebastine is efficacious in the reduction of nasal congestion associated with seasonal allergic rhinitis. This symptomatic effect of ebastine may be accounted for by its ability to reduce inflammatory markers, as shown in preclinical studies, in addition to its primary effect of antagonizing histamine H1 receptors.

Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring.

BACKGROUND: Cysteinyl leukotrienes are important proinflammatory mediators believed to have a role in allergic rhinitis. OBJECTIVE: This multicentre, randomized, double-blind, placebo- and active-controlled trial evaluated the effectiveness and tolerability of montelukast, a cysteinyl leukotriene receptor antagonist, for treating patients with seasonal allergic rhinitis. METHODS: After a 3- to 5-day, single-blind placebo run-in period, 1302 male and female patients (aged 15-81 years) with active allergic rhinitis symptoms were randomly assigned to receive montelukast 10 mg (n = 348), loratadine 10 mg (n = 602), or placebo (n = 352) administered once daily at bedtime for 2 weeks during the spring allergy season. RESULTS: Mean patient characteristics and symptom scores at baseline were similar for the three treatment groups. The primary end-point, daytime nasal symptoms score (mean of nasal congestion, rhinorrhea, nasal pruritus, and sneezing scores; 0-3 scale), improved from baseline during treatment by (least squares mean, 95% confidence interval) - 0.37 (- 0.43, - 0.31), - 0.47 (- 0.52, - 0.43), and - 0.24 (- 0.29, - 0.18) in the montelukast, loratadine, and placebo groups, respectively (P < or = 0.001 comparing each active treatment with placebo). Mean changes from baseline in all other diary-based scores, including night-time and eye symptom scores, were significantly greater for each active treatment than for placebo. The rhinoconjunctivitis quality of life overall score improved significantly with montelukast and with loratadine as compared with placebo. Montelukast and loratadine showed a safety profile comparable to that of placebo. CONCLUSION: Montelukast is well tolerated and provides improvements in daytime and night-time symptoms, as well as quality of life parameters, for patients with seasonal allergic rhinitis.

Using structural equation modeling to examine factors that influence sunburn frequency and severity among adults living in Canada.

This study uses structural equation modeling to examine hypothesized relationships between sunburn and physical characteristics and potentially modifiable behavior. The analysis was based on self-reported data collected from a randomly selected national sample of Canadian adults. An initial model was tested with 50% of the cases (n = 1,408); the remaining cases (n = 1,298) were reserved for confirmatory testing. After the initial model failed, theoretically plausible effects were added incrementally to improve overall model fit. The initial model yielded: chi2(68 d.f.) = 3199.41 (P < .001) and the AGFI = .56. With 32 added effects, a fit model resulted in: chi2(36 d.f.) = 394.35 (P < .001), AGFI = 0.87, and IFI = 0.91 (the Critical-N was 210). Model fit was confirmed. Suntanning, failure to wear protective clothing, and sun exposure were associated with the frequency of severity-adjusted sunburns. Sunscreen use was not associated with sunburn frequency-severity.

A meta-analysis of mammography screening promotion.

The purpose of this study was to identify factors that influence the effectiveness of interventions in increasing women's use of mammography screening programs. To this end, we conducted a systematic literature review of studies published between 1966 and 1997. In this review, we recorded data about the year and country in which studies were completed, the study design, the methods for measuring screening rates, various sample characteristics, the nature of the intervention, and the resulting screening rates. The PRECEDE model was used as a framework to make distinctions between the various interventions. To synthesize evidence about the baseline screening rates and the effect of interventions on the incidence of mammography screening, we fit random-effects logistic regression models. These models revealed that more recent studies (those conducted from 1990 to 1996) were associated with higher screening rates (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.2-3.9). Conversely, those designed to target older women (minimum age, 50-65 years) and those set in clinics exhibited smaller screening rates (OR, 0.6, 95% CI, 0.3-1.0, and OR, 0.5; 95% CI, 0.3-0.8, respectively). The meta-analyses also suggested methodologic issues that must be considered before the relative strength of various interventions can be assessed rigorously.

Falling through the cracks. Women's experiences of ineligibility for genetic testing for risk of breast cancer.

OBJECTIVE: To describe experiences of women seeking information about their risk of hereditary breast cancer who fail to meet strict eligibility criteria for genetic counseling and testing. DESIGN: Qualitative descriptive study. SETTING: Hereditary cancer program in western Canada. PARTICIPANTS: Women who had received notification of their ineligibility for referral for hereditary breast cancer risk assessment (n = 20) and some of their referring physicians (n = 10). Of 28 attempted contacts, five women had moved, one declined the invitation to participate, and two could not be interviewed because of scheduling conflicts. Ten of 20 physicians declined the invitation to participate. METHOD: In-depth, open-ended telephone interviews were conducted. Transcribed interviews were systematically analyzed to identify salient themes. MAIN FINDINGS: Three themes emerged. The first theme, "It's always on your mind," points to the profound concern about breast cancer that underlies women's experiences in seeking genetic testing. The second theme, "A test is a test," reflects women's beliefs that the test was relatively simple and similar to other medical tests in that it would provide a definitive answer. The third theme, "Falling through the cracks," captures the experience of ineligibility. Women reacted with a range of emotional responses and were left frustrated in their search for more specific information about their personal risk for breast cancer. Although women were encouraged to contact their physicians, few did. CONCLUSION: These findings point to the psychological consequences in women who seek genetic testing for risk of breast cancer when they are told they are ineligible and they are not given adequate information and support.

Comparison of once-daily ebastine 20 mg, ebastine 10 mg, loratadine 10 mg, and placebo in the treatment of seasonal allergic rhinitis. The Ebastine Study Group.

BACKGROUND: Ebastine and loratadine are 2 nonsedating second-generation H(1) antihistamines with once-daily dosing. OBJECTIVE: We compared the efficacy and safety of ebastine 20 mg and 10 mg, loratadine 10 mg, and placebo administered once daily for 4 weeks in controlling the symptoms of seasonal allergic rhinitis (SAR). METHODS: In a double-blind, placebo-controlled, randomized, parallel-group study, 565 patients with ragweed SAR, ages 12 to 70 years, received either ebastine 20 mg, ebastine 10 mg, loratadine 10 mg, or placebo once daily for 4 weeks. Patients recorded morning and evening reflective scores (past 12 hours) as well as snapshot scores (at time of recording) for nasal discharge, congestion, sneezing, itching, and total eye symptoms. Total symptom score (TSS) is the sum of these 5 scores. RESULTS: Ebastine 20 mg produced significantly greater (P <.05) reductions from baseline compared with loratadine 10 mg over the entire treatment period in the mean daily reflective (42.5% vs 36.3%) and mean morning snapshot (40.3% vs 31.3%) TSS. The overall improvement in daily reflective and morning snapshot TSS was comparable between ebastine 10 mg and loratadine 10 mg and significantly better than placebo (P <.05). The total percent of patients with adverse events was similar among all 4 treatment groups (P =.78). CONCLUSION: Ebastine 20 mg given once daily was significantly superior to loratadine 10 mg given once daily at improving the rhinitis total symptom score throughout the day and at awakening over a 4-week period. Ebastine 20 mg and 10 mg doses were both efficacious and well tolerated in the treatment of SAR.

Narratives of smoking relapse: the stories of postpartum women.

Many women who stop smoking during pregnancy relapse soon after the birth of their infants. Using narrative research, experiences of smoking relapse were explored using interviews with 27 postpartum women. The stories of relapse were analyzed to identify important components, paying attention to commonalities, differences, and areas of emphasis. Five general story lines were identified: (1) controlling one's smoking (starting with a "puff" and consciously restricting the amount smoked); (2) being vulnerable to smoking(relapsing because of an inability to resist cigarettes); (3) nostalgia for one's former self(relapsing to recapture feelings of freedom and happier times); (4) smoking for relief(relapsing to manage emotions and stress); and (5) never really having quit (relapsing because they did not quit for themselves). The findings of this study provide support for the claim that the experiences of smoking cessation and relapse among postpartum women may be unique and, consequently, may require specialized intervention.

Twelve-month follow-up of a smoking relapse prevention intervention for postpartum women.

This study examined the long-term effectiveness of a postpartum smoking relapse prevention intervention by evaluating the smoking status and smoking cessation self-efficacy of original study participants at 12 months following delivery. Two hundred and thirty-eight women who had participated in a randomized clinical trial, a nurse-delivered relapse prevention intervention, were visited in their homes. Data were collected on smoking status, self-efficacy, mental health, alcohol use, breast feeding, social support, smoking in the social environment, and sociodemographics. Smoking status was verified with measures of carbon monoxide in expired air. The 12-month continuous smoking abstinence rate was 21.0% in the treatment group and 18.5% in the control group; odds ratio (OR) = 1.17, 95% confidence interval (CI) = 0.62-2.22. One half (50.4%) of the control group and 41.2% of the treatment group reported smoking daily at 12 months; OR = 1.45, 95% CI = 0.87-2.43. The treatment group attained higher self-efficacy. Four variables were associated with relapse to daily smoking; breast feeding and mental health had protective effects, while partners who smoked and greater amount smoked prior to pregnancy had adverse effects.

Preventing smoking relapse in postpartum women.

BACKGROUND: Although many women quit smoking during pregnancy, the majority resume smoking shortly after giving birth. OBJECTIVES: To test a program to prevent smoking relapse in the postpartum period by comparing the rates of continuous smoking abstinence, daily smoking, and smoking cessation self-efficacy in treatment and control groups. METHODS: In a randomized clinical trial, nurses provided face-to-face, in-hospital counseling sessions at birth, followed by telephone counseling. The target population included women who quit smoking during pregnancy and who gave birth at one of five hospitals. The 254 participating women were interviewed 6 months after delivery and assessed biochemically to determine smoking status. RESULTS: The 6-month continuous smoking abstinence rate was 38% in the treatment group and 27% in the control group (odds ratio [OR] = 1.63, 95% confidence interval [CI] .96 - 2.78). Significantly more control (48%) than treatment (34%) group participants reported smoking daily (OR = 1.80, 95% CI = 1.08 - 2.99). Smoking cessation self-efficacy did not vary significantly between the groups. CONCLUSIONS: Smoking cessation interventions focusing on the prenatal period have failed to achieve long-term abstinence. Interventions can be strengthened if they are extended into the postpartum period.

Dose-ranging study of a new steroid for asthma: mometasone furoate dry powder inhaler.

A new formulation of mometasone furoate (MF) for administration by dry powder inhaler (DPI) was evaluated for the treatment of asthma. A 12-week, double-blind, placebo-controlled dose-ranging study compared the efficacy and safety of three doses of MF DPI (100, 200 and 400 mcg b.i.d) with beclomethasone dipropionate (BDP) 168 mcg b.i.d. administered by metered dose inhaler in 365 adult or adolescent patients being treated with inhaled glucocorticoids. The mean change from baseline to endpoint (last treatment visit) for forced expiratory volume in 1 sec (FEV1) was the primary efficacy variable. Secondary efficacy variables included other objective measures of pulmonary function [forced vital capacity (FVC), forced expiratory flow 25-75% (FEV25-75%.) and peak expiratory flow rate (PEFR)] as well as subjective measures of therapeutic response (patients' daily evaluation of asthma symptoms and physicians' evaluation). At endpoint, all four active treatments were significantly more effective than placebo (P < 0.01) in improving FEV1 (MF DPI 5 to 7%, BDP 3%, placebo -6.6%) and all other measures of pulmonary function (FVC: MF DPI 4 to 5%, BDP 2%, placebo -4.7%; FEF25-75%: MF DPI 6 to 18%, BDP 7.5%, placebo -9.5%; PEFR (AM): MF DPI 5 to 10%, BDP 5.7%, placebo -7%). A consistent trend was observed for better improvement in patients treated with MF DPI 200 mcg b.i.d. than with MF DPI 100 mcg b.i.d., with no apparent additional benefit of MF DPI 400 mcg b.i.d. Results for the MF DPI 100 mcg b.i.d. and BDP 168 mcg b.i.d. treatment groups were similar. Patients' and physicians' subjective evaluations of symptoms found similar improvement in the MF DPI 200 and 400 mcg b.i.d. treatment groups, which were slightly better than that in the MF DPI 100 mcg b.i.d. group. Symptoms tended to worsen in the placebo group. MF DPI was well tolerated at all dose levels and the most frequently reported treatment-related adverse effects were headache, pharyngitis and oral candidiasis. No evidence of HPA-axis suppression was detected in any treatment group. In summary, all doses of MF DPI were well tolerated and significantly improved lung function and MF DPI 400 mcg (200 mcg b.i.d.) was the optimal dose in this study of patients with moderate persistent asthma.

A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis.

BACKGROUND: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 microg once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric patients has not yet been characterized. OBJECTIVE: This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population. METHODS: This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 microgram once daily, MFNS 100 microgram once daily, MFNS 200 microgram once daily, beclomethasone dipropionate 84 microgram twice daily (168 microgram/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29. RESULTS: The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group (P