Desloratadine improves quality of life and symptom severity in patients with allergic rhinitis

BACKGROUND: Desloratadine is associated with decreased signs and symptoms and improved nasal airflow in multiple clinical trials in patients with allergic rhinitis (AR). The effect of desloratadine on quality of life (QOL) in AR has not been widely reported to date. We compared the effects of desloratadine and placebo on QOL in seasonal AR using validated, disease-specific measures. METHODS: This was a multicenter, double-blind, randomized, parallel-group study of desloratadine 5 mg or placebo daily for 2 weeks in patients with symptomatic seasonal AR. QOL was assessed at baseline and at day 14 using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). AR signs/symptoms and the global response to therapy were measured at baseline and at day 14; signs/symptoms were also rated AM/PM in patient diaries. Adverse events (AE) were recorded. RESULTS: Overall 234 patients received desloratadine and 249 received placebo. At day 14 desloratadine was associated with a significantly larger improvement from baseline in the mean total RQLQ score vs placebo (P = 0.0003). Desloratadine also led to significant improvements from baseline in all RQLQ sub-domains (P < or = 0.043). At day 14 significant decreases from baseline were noted in the desloratadine group for total nasal (P = 0.0003), total non-nasal (P = 0.001) and total symptoms scores (P = 0.0001). Morning AR symptoms were significantly decreased in the desloratadine group after 1 day of treatment. Desloratadine was well tolerated, with an AE rate similar to placebo. CONCLUSION: Significant reductions in signs and symptoms of AR with desloratadine treatment were accompanied by improved disease-specific QOL measures.     

Levocetirizine in persistent allergic rhinitis and asthma: effects on symptoms, quality of life and inflammatory parameters

Background Levocetirizine (LCZ) has been shown to be effective in allergic rhinitis. We evaluated its clinical efficacy, antinflammatory actions and its effects on quality of life (QoL) with a specific instrument in the asthma-rhinitis comorbidity. Methods Fifty adult patients with persistent rhinitis with/without asthma were enrolled. After a 1-week run-in for baseline evaluation, they were randomized to LCZ or placebo for 8 weeks. Cromolyn and salbutamol were permitted on demand. Rhinoconjunctivitis and asthma symptoms were evaluated by diary cards. QoL was assessed by the specific Rhinasthma questionnaire and the generic SF-36 at different time-points. Nasal scrapings and lavages were also performed for inflammatory cell count and mediator assessment. Results Ten patients dropped out for unrelated reasons and the remaining completed the study with no side-effect. Symptoms began to decrease in the active group at the second week of treatment when the difference with the placebo group became significant (0.05) and so remained until the end of the trial. Starting from 2 weeks of therapy, there was a significant decrease vs. baseline in all the four components of the Rhinasthma questionnaire only in the active group. The intergroup comparison became significant (P<0.05) at 4 weeks. The SF-36 detected only sporadic differences between groups. Eosinophils and neutrophils in nasal scraping were significantly decreased in the LCZ group vs. baseline at all times. Nasal mediators were under the detection limits and no analysis could be performed. In the active group, only two patients used rescue medications compared with 13 patients in the placebo group. Conclusions LCZ is clinically effective and capable of improving the rhinitis-asthma-related QoL.     

Health-related quality of life assessment in young adults with seasonal allergic rhinitis

BACKGROUND: In health-related quality of life (HRQL) studies on allergic rhinitis, both disease-specific and generic questionnaires have been extensively used. Seasonal allergic rhinitis (SAR) has been studied mainly by focusing on symptomatology. The present study aimed to evaluate the SAR-HRQL by means of two questionnaires, the Medical Outcome Study Short Form Health Survey (SF-36) and a new instrument examining satisfaction in 32 aspects of daily life: the Satisfaction Profile (SAT-P). METHODS: Thirty-three patients with SAR (aged 33.5+/-8.5 years; 12 men, 21 women) were evaluated during and 2 months after the pollen season. Data were compared with reference samples by t-test, and baseline and follow-up HRQL scores were compared by a matched-pair test. RESULTS: Patients' HRQL scores collected during the pollen season were significantly lower than reference sample data in many SF-36 scores and in one SAT-P item. No differences emerged between SF-36 and SAT-P scores collected outside the pollen season and reference sample scores. Compared to baseline, outside the pollen season, patients reported significantly higher scores in the following SF-36 scales: physical functioning (P=0.002), physical role (P=0.00001), bodily pain (P=0.01), and vitality (P=0.008); and significantly higher scores in only two SAT-P items (physical well-being [P=0.009] and resistance to stress [P=0.01]). CONCLUSIONS: Our data confirm the utility of using symptomatologic and health-status questionnaires in evaluating the HRQL of SAR patients. More general quality of life questionnaires may prevent the symptomatologic and functional problems from being adequately recognized and managed. SAT-P can be a fruitful additional tool in HRQL evaluation.     

Quality of life in allergic rhinitis: relationship with clinical, immunological, and functional aspects

BACKGROUND: The relationship among nasal obstruction, T-helper type 2-dependent inflammation, nasal airflow limitation, and reversibility to the nasal decongestion test has been evidenced in allergic rhinitis (AR). Moreover, quality of life (QoL) has been widely evaluated in AR and its evaluation is considered in numerous trials. OBJECTIVE: The aim of this cross-sectional study was to identify the QoL as measured by the Quality of Life Questionnaire in a population of patients with AR and to compare it with clinical, immunological, and functional parameters. METHODS: One hundred and twenty-three patients with persistent AR were prospectively and consecutively evaluated. Clinical evaluation, skin prick test, nasal scraping for cytology, rhinomanometry, decongestion test, and QoL questionnaire were performed in all subjects. RESULTS: There was a significant relationship among QoL and functional and immunological parameters. Particularly, the multivariate analysis showed that having more than two sensitivities was a determinant of the QoL. The eosinophil count was significantly associated with QoL as well as the baseline nasal flow (mL/s) with the eye symptoms scale only. CONCLUSIONS: This study provides the first evidence that QoL in AR is strictly associated with allergic inflammation and eye symptoms significantly contribute to impairment of QoL. QoL, moreover, represents an important aspect to consider in managing patients with AR as it has a relationship with clinical, immunological, and functional parameters.     

The health-related quality of life effects of once-daily cetirizine HCl in patients with seasonal allergic rhinitis: a randomized double-blind, placebo-controlled trial

BACKGROUND: Seasonal allergic rhinitis (SAR) is characterized by subjectively irritating symptoms that can have a substantial impact on the patient's health-related quality of life (HRQL), adversely affecting physical and social or work activity, interpersonal relationships, and general psychological well-being. The objective of this study was to test the effect of cetirizine HCl 10 mg once daily on the HRQL of adult patients 18-65 years of age with SAR, concurrently assessing safety and efficacy. METHODS: Randomized double-blind, placebo-controlled, parallel group trial conducted during the 1999 spring SAR season at 19 centers in the US. Following a 1-week placebo run-in period, qualified patients were randomized to cetirizine 10 mg, or placebo once daily for a 2-week treatment period. Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Total Symptom Severity Complex (TSSC) scores from baseline were the primary outcomes of interest. RESULTS: Of the 611 patients enrolled, 403 (66%) were randomized. Cetirizine-treated patients reported significantly greater improvement in overall HRQL (P < 0.001) and in each of the seven domains of the RQLQ at all time-points (P < 0.05 to < 0.001) than the placebo group. They also experienced significantly greater symptom relief (P < 0.001) and were more satisfied with treatment (65% vs. 44%) compared to the placebo group. Correlations between symptomatic relief and overall HRQL improvement were moderate to strong and statistically significant (r = 0.49-0.68, P < 0.01). CONCLUSIONS: Results of this study are consistent with previous investigations, suggesting cetirizine HCl 10 mg taken once daily in the morning offers symptomatic relief that improves the HRQL of adults suffering from SAR.     

Effects of budesonide and fluticasone propionate in a placebo-controlled study on symptoms and quality of life in seasonal allergic rhinitis

BACKGROUND: Intranasal glucocorticosteroids are effective in seasonal allergic rhinitis. This study compared the efficacy of budesonide (Rhinocort Turbuhaler) and fluticasone propionate (Flixonase) in this respect. METHODS: Patients (n = 280) were randomized to receive budesonide, 140 microg (delivered dose) once daily, fluticasone, 200 microg once daily, or matching placebos for 5 weeks. The primary efficacy variable was the change in combined nasal symptom (nasal blockage, runny nose, sneezing) scores. Quality of life was measured in 121 patients by means of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and the Short-form Health Survey (SF-36). RESULTS: Both steroids significantly reduced combined nasal symptoms, compared with placebo. There was no significant difference between the two treatments. Substantial or total symptom control was achieved in 89.9% of the budesonide-treated patients, compared with 88.7% with fluticasone and 42.7% with placebo. Four of the five domains of the RQLQ were significantly improved with budesonide, whereas with fluticasone only two domains were improved. Budesonide significantly improved scores in five out of eight domains of the SF-36, whereas no domains were improved with fluticasone. CONCLUSION: There was no significant difference in efficacy between budesonide and fluticasone in this study. However, greater improvements in quality of life were seen with budesonide than with fluticasone.     

Quality of life in adults and children with asthma and rhinitis

Many clinicians now recognize the importance of incorporating an assessment of health-related quality of life (HRQL) into their clinical studies and practice. Conventional clinical measures provide valuable information about the status of the affected organ system, but they rarely capture the functional impairments (physical, emotional, and social) that are important to the patients in their everyday lives. In order to obtain a complete picture of a patient's health status, both the conventional clinical indices and the patient's HRQL must be measured. Both adults and children with asthma and rhinitis are distressed by the symptoms, and they are limited in their day-to-day activities such as sports, work or school work, and participation in other activities with friends. In addition, both adults and children experience emotional strain as a result of both conditions. Disease-specific HRQL questionnaires have been developed and validated for both adults and children with asthma and rhinitis. These questionnaires have good measurement properties and validity and can be used in both clinical trials and clinical practice to assess the impact of the condition on a patient's life. Since one of the aims of treatment is to ensure that patients benefit from it, an essential component of clinical assessment should be an evaluation of HRQL.     

Relationship between allergic rhinitis, disturbed cognitive functions and psychological well-being

BACKGROUND: Symptomatic allergic rhinitis reduces quality of life as a result of the symptoms experienced and possibly as a result of impaired psychological well-being and cognitive functioning. Few investigations have measured cognitive functions objectively and it remains uncertain whether allergic rhinitis leads to an objective reduction in cognitive functions. OBJECTIVE: To evaluate the relationship between symptomatic allergic rhinitis, cognitive functions and psychological well-being. Differences between subjective and objective cognitive impairments were evaluated. METHODS: The cognitive functions (working memory, memory retrieval, speed of information processing and flexibility of information processing) and psychological well-being of 26 patients with symptomatic allergic rhinitis and 36 healthy controls matched for intelligence, education, age and sex were compared. The influence of education, intelligence, sex and age was considered. RESULTS: Overall, psychological well-being was significantly impaired in the patient group, as shown by higher scores in feelings of insufficiency, complaints of somatization, sleep disturbances and depressive feelings, whereas cognitive function was not. CONCLUSIONS: Allergic rhinitis was related to significantly impaired psychological well-being and to perceived impaired cognitive functioning. However, no significant objective impairment of cognitive functioning was found. Allergic patients may temporarily put more effort into sustaining performance, resulting in earlier exhaustion, which is not noticed during assessment but which impairs psychological well-being.     

Visual analog scales can assess the severity of rhinitis graded according to ARIA guidelines

BACKGROUND: The allergic rhinitis and its impact on asthma (ARIA) guidelines provide a new classification of allergic rhinitis, but a quantitative analysis for severity assessment is lacking. OBJECTIVE: To study whether a visual analog scale (VAS) for global rhinitis symptoms could be used to assess the disease severity according to ARIA. METHODS: Three thousand fifty-two allergic rhinitis patients seen in primary care were tested. Fifty three per cent had an objective diagnosis of allergy and 58% of the patients were treated. Patients were categorized according to ARIA guidelines. The severity of nasal symptoms was assessed using a VAS. Quality of life was measured using the rhinoconjunctivitis quality of life questionnaire (RQLQ). RESULTS: Severity had more impact on VAS levels than duration: mild intermittent rhinitis (3.5, 2.4-5.0 cm), mild persistent rhinitis (4.5, 3.2-5.6 cm), moderate/severe intermittent rhinitis (6.7, 5.3-7.7 cm) and moderate/severe persistent rhinitis (7.2, 6.1-8.2 cm). The receiver operating characteristic curve results showed that patients with a VAS of under 5 cm could be classified as 'mild' rhinitis (negative predictive value: 93.5%) and those with a VAS of over 6 cm as 'moderate/severe' rhinitis (positive predictive value: 73.6%). Receiver operating characteristic curves and a logistic regression showed that current treatment and allergy diagnosis have no effect on the assessment of rhinitis severity using VAS. Visual analog scale and the RQLQ global score were significantly correlated (rho = 0.46; P < 0.0001). CONCLUSION: A simple and quantitative method (VAS) can be used for the quantitative evaluation of severity of allergic rhinitis.