311 research outputs found
Systematic Review on the Efficacy of Fexofenadine in Seasonal Allergic Rhinitis: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Clinical Trials
Rationale: Evidence-based medicine represents the effort to highlight the best intervention for patients, clinicians, and policy makers, each from their respective viewpoint, to solve a particular health condition. According to a recently diffused grading system of evidence and recommendations for medical interventions, efficacy and safety represent 2 of the most important features to consider, and data from meta-analyses of randomized controlled clinical trials (RCTs) is the strongest supporting demonstration. Fexofenadine has been used for its efficacy and safety in the treatment of allergic rhinitis (AR) for many years although no meta-analyses supporting its use currently exist. The aim of this study is to assess for the first time the efficacy and safety of fexofenadine in the treatment of AR by means of a meta-analytic analysis of existing RCTs. Since specific evidence should be provided to address recommendations in a pediatric population, the quality of the estimates of this subgroup analysis is assessed. Methods: All double-blind, placebo-controlled randomized trials assessing the efficacy of fexofenadine in AR were searched for in OVID, Medline, and Embase databases up to December 2007. Outcomes were extracted from original articles; when this information was not available, the authors of each trial were contacted. Some graphics were digitalized. The RevMan 5 program was used to perform the analysis. GradePro 3.2.2 was used to assess the quality of the evidence for a pediatric population. Results: Of 2,152 identified articles, 20 were potentially relevant trials. Eight studies satisfied the inclusion criteria and were included in the meta-analysis. The main reasons for exclusion were: unnatural exposure, strong study limitations, an atypical outcome measurement, a design for other outcomes, and not being a placebo-controlled, single-blind study. Seven trials investigated a mixed population of adults and children, 1 trial investigated only children, and 1 trial only adults. In 1,833 patients receiving fexofenadine (1,699 placebo), a significant reduction of the daily reflective total symptom scores (TSS) (SMD –0.42; 95% CI –0.49 to –0.35, p < 0.00001) was found. Positive results were also found for morning instantaneous TSS and individual nasal symptom scores (sneezing, rhinorrhea, itching, and congestion). The safety analysis did not show a significant difference in reported adverse events (AE) between the active and placebo treatment groups (OR = 1.03; 95% CI 0.87–1.22, p = 0.75). A very low heterogeneity between the studies was detected, so a fixed-effects model was used. The mean quality level of the included trials was medium. Specific information for a pediatric population may be assumed with a moderate quality of evidence from only 1 study and with a low quality of evidence, mainly due to indirectness, from the others. Conclusions: This study has 5 major strengths: it represents the first attempt to evaluate the efficacy and safety of fexofenadine in the treatment of AR by means of a meta-analysis of RCTs; there was consistency between positive results in terms of efficacy in TSS and in individual symptoms; a large population was studied; there was an irrelevant interstudy heterogeneity, and the AE frequency was similar in both groups. All of these values encourage the recommendation of fexofenadine for AR. Further research focused on the benefits and disadvantages for a pediatric population is needed
Olfactory Dysfunction in Patients with Chronic Rhinosinusitis
Objectives. To measure the prevalence of and identify the clinical characteristics associated with olfactory decline in patients with chronic rhinosinusitis. Methods and Materials. There is analytical, prospective, and observational study in adult patients with a diagnosis of chronic rhinosinusitis. The olfactory test used was the Connecticut Chemosensory Clinical Research Center (CCCRC). Results. They are 33 patients total. Within the group of patients aged 18 to 39, 9% had normosmia, 73% hyposmia, and 18% anosmia (P<0.001). Between 40 and 64 years old, there was no patient with normosmia, 63% hyposmia, and 37% anosmia (P<0.001). Of patients older than 65 years old, 33% showed mild hyposmia, 34% severe hyposmia, and 33% anosmia (P<0.001). 52% were females, and 48% were males. Conclusion. Nasal polyposis, asthma, septal deviation, turbinate hypertrophy, tobacco, and allergic rhinitis are predicting factors of olfactory dysfunction. Antecedents of previous endoscopic surgeries, age, and gender would not be associated with olfactory loss
Unmet needs in allergic rhinitis: international survey on management of allergic rhinitis by physician and patient. The physicians' view (ISMAR 2 study)
Barriers to Asthma Treatment in the United States: Results From the Global Asthma Physician and Patient Survey
BACKGROUND: The Global Asthma Physician and Patient (GAPP) survey evaluated the perceptions of both physicians and patients on the management of asthma. Here we present the results from the United States (US) subpopulation of the GAPP survey. METHODS: The GAPP Survey was a large, global study (physicians, n = 1733; patients, n = 1726; interviews, n = 3459). In the US, 208 adults (aged ≥ 18 years) with asthma and 224 physicians were recruited. Respondents were questioned using self-administered online interviews with close-ended questionnaires. RESULTS: Physician and patient responses were found to differ in regard to perception of time spent on asthma education, awareness of disease symptoms and their severity, asthma medication side effects, and adherence to treatment and the consequence of nonadherence. Comparison of the US findings with the global GAPP survey results suggest the US physician-patient partnership compared reasonably well with the other countries in the survey. Both patients and physicians cited a need for new asthma medication. CONCLUSIONS: Similar to the global GAPP survey, the US-specific findings indicate that in general there is a lack of asthma control, poor adherence to therapy, and room for improvement in patient-physician communication and partnership in treating asthma
Fexofenadine is Efficacious and Safe in Children (Aged 6-11 Years) with Seasonal Allergic Rhinitis
Background: This is the first prospective, randomized, doubleblind, placebo-controlled study showing statistical improvement
of an H1-antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period.
Objective: This randomized, placebo-controlled, parallelgroup,double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis.
Methods: This study was conducted at 148 centers in 15 countries. Nine hundred thirty-five children (aged 6-11 years)
were randomized and treated with either fexofenadine HCl 30 mg (n = 464) or placebo (n = 471) tablets twice a day for 14
days. Individual symptoms (sneezing; rhinorrhea; itchy nose, mouth, throat, and/or ears; itchy, watery, and/or red eyes; and nasal congestion) were assessed at baseline and then daily at 7:00 AM and 7:00 PM (±1 hour) during the double-blind treatment period. Each total symptom score was the sum of all symptoms, excluding nasal congestion. The primary efficacy
variable was the change from baseline in the average of the daily 12-hour evening reflective total symptom scores throughout
the double-blind treatment. Safety was evaluated from adverse-event reporting, vital signs, physical examinations,
and clinical laboratory data at screening and study end point
The effect of ketotifen on inflammatory markers in allergic conjunctivitis: an open, uncontrolled study
BACKGROUND: The efficacy and safety of ketotifen eye drop treatment in allergic conjunctivitis (AC) management is perfectly known by several studies, but the mechanism of action at the biochemical levels is poorly understood so we decided to perform an open, uncontrolled study in order to investigate the effect of the topical administration of ketotifen fumarate 0.05% on biochemical markers of inflammation on conjunctival cells in patients with AC. METHODS: Nineteen patients with symptoms and signs of AC (itching, discharge, burning, redness, increase in the watery discharge, swelling and follicles) and with a history of allergy were prescribed with two daily instillation of one drop of eyewash ketotifen fumarate 0,05% in both eyes during thirty days. They were studied by measuring clinical and immunologic parameters. RESULTS: Ketotifen fumarate treatment significantly reduced the total symptoms and signs score for each patient as well as each symptoms and signs at all time points compared with day 0 (p < 0.0001 and p < 0.016, respectively). Although the percentage of HLA-DR+ epithelial cells diminished only in 58% of patients, the numbers of CD29+ and eotaxin+ epithelial cells dropped significantly in 68% and 73 % of them (p < 0.0062 and <0.0082, respectively) as a consequence of the treatment. In 9 out of 19 patients a simultaneous decrease in the percentage of epithelial cells positive for CD29 and eotaxin was observed. CONCLUSION: Ketotifen besides the well-known effect in reducing signs and symptoms of AC significantly diminished production of eotaxin and expression of CD29 by epithelial cells in patients with seasonal AC
100 Years of Immunotherapy: The Monaco Charter
Aims of the Monaco Charter: (1) to present the current evidence on the efficacy and safety of allergen-specific immunotherapy (SIT) and to address the reasons for its underuse
in clinical practice; (2) to develop strategies to increase the
awareness about the benefits and the hazards of SIT in allergic patients, lay public and healthcare professionals not
trained in allergy, and (3) to make SIT accessible and affordable to eligible patient
Challenges in the implementation of the EAACI AIT guidelines:A situational analysis of current provision of allergen immunotherapy
Purpose:The European Academy of Allergy and Clinical Immunology (EAACI) has produced Guidelines on Allergen Immunotherapy (AIT). We sought to gauge the preparedness of primary care to participate in the delivery of AIT in Europe.Methods:We undertook a mixed-methods, situational analysis. This involved a purposeful literature search, and two surveys: one to primary care clinicians and the other to a wider group of stakeholders across Europe.Results:The 10 papers identified all pointed out gaps or deficiencies in allergy care provision in primary care. The surveys also highlighted similar concerns, particularly in relation to concerns about lack of knowledge, skills, infrastructural weaknesses, reimbursement policies and communication with specialists as barriers to evidence-based care. Almost all countries (92%) reported the availability of AIT. In spite of that, only 28% and 44% of the countries reported the availability of guidelines for primary care physicians and specialists, respectively. Agreed pathways between specialists and primary care physicians were reported as existing in 32-48% of countries. Reimbursement appeared to be an important barrier as AIT was only fully reimbursed in 32% of countries. Additionally, 44% of respondents considered accessibility to AIT and 36% stating patient costs were barriers.Conclusions:Successful working with primary care providers is essential to scaling-up AIT provision in Europe, but to achieve this the identified barriers must be overcome. Development of primary care interpretation of guidelines to aid patient selection, establishment of disease management pathways and collaboration with specialist groups are required as a matter of urgency
Mometasone and desloratadine additive effect on eosinophil survival and cytokine secretion from epithelial cells
Although antihistamines and topical corticosteroids are used in combination to treat allergic rhinitis, their additive effect has not been yet demonstrated. The aim was investigate the antiinflammatory additive effect of mometasone and desloratadine on cytokine and sICAM-1 secretion by epithelial cells, and on eosinophil survival stimulated by human epithelial cells secretions from nasal mucosa and polyps. Methods Epithelial cells obtained from nasal mucosa or polyps were stimulated with 10% fetal bovine serum in presence of mometasone (10-11M-10-5M) with/without desloratadine (10-5M). Cytokine and sICAM-1 concentrations in supernatants were measured by ELISA. Peripheral blood eosinophils were incubated during 4 days with epithelial cell secretions with (10-11M-10-5M) and/or desloratadine (10-5M) and survival assessed by Trypan blue. Results are expressed as percentage (mean ± SEM) compared to control. Results Fetal bovine serum stimulated IL-6, IL-8, GM-CSF and sICAM-1 secretion. In mucosa and polyp epithelial cells, mometasone inhibited this induced secretion while desloratadine inhibited IL-6 and IL-8. The combination of 10-5M desloratadine and 10-9M mometasone reduced IL-6 secretion (48 ± 11%, p < 0.05) greater extent than mometasone alone (68 ± 10%) compared to control (100%). Epithelial cell secretions induced eosinophil survival from day 1 to 4, this effect being inhibited by mometasone. At day 4, the combination of mometasone (10-11M) and desloratadine (10-5M) provoked an increased inhibition of eosinophil survival induced by cell secretions (27 ± 5%, p < 0.01) than mometasone (44 ± 7%) or desloratadine (46 ± 7%) alone. Conclusions These results suggest that the combination of desloratadine and mometasone furoate have a greater antinflammatory effect in an in vitro model of eosinophil inflammation than those drugs administered alone
Recent Developments in United Airways Disease
The nose and lung are both part of the respiratory tract. Often the diseases affecting the nose and/or the bronchi are treated separately. However, in recent years, numerous studies have highlighted the fact that the respiratory system is a single entity and the concept of "united airway disease" has become more and more important. The unity of the respiratory tract is confirmed both from a morphological and from a functional point of view. Nevertheless, this concept is also confirmed for the respiratory immune system, innervation and vascularization interesting all along the tract, from the nose to the bronchioles. When treating rhinitis, it is often necessary to assess the presence of asthma. Patients with sinusitis should be evaluated for a possible concomitant asthma. Conversely, patients with asthma should always be evaluated for possible nasal disease. The medications that treat nasal diseases appear to be useful in improving control of asthma and in reducing bronchial hyperresponsiveness as well. Physicians should always keep these notions in mind, and evaluate and treat respiratory diseases taking into account the unity of the respiratory tract
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