Abstract:
:Background: GSP301 is an investigational fixed-dose combination nasal spray that contains the antihistamine, olopatadine hydrochloride (HCl), and the corticosteroid, mometasone furoate. Objective: To evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR). Methods: In this double-blind, randomized, parallel-group study, patients (≥12 years of age) with SAR were equally randomized to intranasal GSP301 (olopatadine 665 μg and mometasone 25 μg), olopatadine HCl (665 μg), mometasone furoate (25 μg), or placebo for 14 days of twice-daily treatment. The primary end point was the mean change from baseline in the average A.M. and P.M. 12-hour reflective Total Nasal Symptom Score (rTNSS) analyzed by using mixed-effect model repeated measures (p < 0.05 indicates statistical significance). Additional assessments included instantaneous TNSS (iTNSS), individual nasal symptoms, reflective Total Ocular Symptom Score (rTOSS) and instantaneous Total Ocular Symptom Score (iTOSS), onset of action, Physician-assessed Nasal Symptom Score (PNSS), quality of life, and adverse events (AE). Results: A total of 1180 patients were randomized. Over 14 days of treatment, GSP301 significantly improved average A.M. and P.M. rTNSS versus placebo (least squares mean difference -0.98 [95% confidence interval, -1.38 to -0.57]; p < 0.001) and versus olopatadine (p = 0.003), and approached statistical significance versus mometasone (p = 0.059). GSP301 also significantly improved average A.M. and P.M. iTNSS versus placebo and both monotherapies (p < 0.05, all). Further, GSP301 significantly improved individual nasal symptoms, overall ocular symptoms (rTOSS and iTOSS), and overall quality of life versus placebo (p < 0.01, all). Onset of action for GSP301 was observed within 15 minutes and was maintained at all subsequent time points assessed. Results for the PNSS also were significant for GSP301 versus placebo (p < 0.001). The percentages of patients with treatment-emergent AEs treated with GSP301, olopatadine, mometasone, and placebo were 12.9, 12.5, 7.1, and 9.4%, respectively. Conclusion: GSP301 was efficacious and well tolerated for the treatment of SAR symptoms compared with placebo, with a rapid onset of action of 15 minutes in patients ≥12 years of age.Clinical trial NCT02631551,
journal_name
Allergy Asthma Procjournal_title
Allergy and asthma proceedingsauthors
Hampel FC,Pedinoff AJ,Jacobs RL,Caracta CF,Tantry SKdoi
10.2500/aap.2019.40.4223subject
Has Abstractpub_date
2019-07-03 00:00:00pages
261-272issue
4eissn
1088-5412issn
1539-6304journal_volume
40pub_type
杂志文章,随机对照试验abstract::Rhinitis symptom complex consists of rhinorrhea, congestion, itchy mucosa, itchy eyes, and sneezing. Available medications vary in their benefit for each of these symptoms. It was the purpose of this article to compare symptom reduction with three different classes of medications. Montelukast, azelastine, and budesoni...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:10.2500/aap.2010.31.3308
更新日期:2010-01-01 00:00:00
abstract::Immunobiologic agents are an important therapeutic alternative for severe asthma, atopic dermatitis, and chronic urticaria. In this article, we reviewed the most relevant studies that addressed the use of anti-immunoglobulin E (omalizumab), anti-IL-5 (mepolizumab, reslizumab, and benralizumab), and anti-IL-4/IL-13 (du...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:10.2500/aap.2019.40.4277
更新日期:2019-11-01 00:00:00
abstract::A telephone survey of 100 primary care physicians was performed to assess the awareness of the influence patient preference, patient satisfaction, and other factors have on the selection of nasal steroids for the treatment of allergic rhinitis. Results indicated that physicians believe drug efficacy is the primary rea...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:
更新日期:2001-11-01 00:00:00
abstract::Rhinosinusitis is one of the most common chronic diseases with significant symptoms and impact on the quality of life. Surgery is indicated when appropriate medical treatment fails. A review of the clinical presentations of rhinosinusitis is presented, as well as an overview of current medical and surgical treatment o...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:
更新日期:2006-01-01 00:00:00
abstract::The manufacturing of PrePen (benzylpenicilloyl-polylysine) was suspended from September 2000 through November 2001 because of Food and Drug Administration intervention. PrePen is penicilloyl bound to polylysine and is considered to be the major determinant of penicillin metabolism; it is used as a skin-testing reagent...
journal_title:Allergy and asthma proceedings
pub_type: 临床试验,杂志文章
doi:
更新日期:2004-05-01 00:00:00
abstract::There is well-established evidence that histamine plays a significant role as a chemical mediator in asthma. However, although antihistamines are commonly used for the treatment of allergic rhinitis, their use in asthma has been somewhat controversial. Mechanistically, their application for asthma appears logical. In ...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:
更新日期:2003-07-01 00:00:00
abstract::Community-acquired pneumonia (CAP), the sixth leading cause of death in the United States, has undergone significant changes in the past 30 years. In addition to the fact that it increasingly is a disease affecting the elderly and those patients with underlying comorbidities, the spectrum of microbiological agents cau...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:10.2500/108854100778248980
更新日期:2000-01-01 00:00:00
abstract::Background: The majority of patients for elective surgery and with a history of penicillin allergy are placed on alternative prophylactic antibiotic therapies, which have been associated with the emergence of multidrug-resistant pathogens and increased morbidity and mortality rates. However, self-reporting of penicill...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,meta分析
doi:10.2500/aap.2018.39.4178
更新日期:2018-11-01 00:00:00
abstract::Hereditary angioedema (HAE) is a rare, autosomal dominant, genetic disorder associated with a deficiency in C1 inhibitor protein. HAE is characterized by recurrent and unpredictable episodes of swelling of the extremities, abdomen, face, and upper airway. There are several newly approved drugs as well as investigation...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:10.2500/aap.2019.40.4195
更新日期:2019-01-01 00:00:00
abstract::To date cytokines profile in AEDS is poorly described in children. We evaluated the interleukin (IL)-17, IL-23, and IL-10 levels in atopic eczema/dermatitis syndrome (AEDS) children and healthy controls, in atopic AEDS (aAEDS) and nonatopic (naAEDS) subtypes and their relationship with disease severity. A total of 181...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/aap.2015.36.3808
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:Childhood food allergy and asthma rates are increasing. The hygiene hypothesis has been proposed as an explanation for the increased incidence of allergic disease. OBJECTIVE:To describe the association of childhood food allergy and asthma with hygiene factors, such as the number of siblings, antibiotic use,...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/aap.2016.37.3988
更新日期:2016-11-01 00:00:00
abstract::Penicillin (PCN) allergy has been vastly overdiagnosed, and too many people are incorrectly labeled as allergic to PCN, which affects their health by preventing the use of beta-lactam antibiotics. This investigation explores whether taking a careful history can eliminate the need for some to carry the PCN allergy labe...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:
更新日期:2005-01-01 00:00:00
abstract::Intranasal corticosteroids (INCSs) provide safe and effective treatment of allergic rhinitis (AR). Currently available INCSs differ in terms of the components included in each formulation that may influence efficacy, tolerability, and patient preference for treatment. Patient preference for a specific INCS is largely ...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:10.2500/aap.2007.28.2993
更新日期:2007-05-01 00:00:00
abstract::Hereditary angioedema (HAE) is a rare inherited disorder of complement factor C1 inhibitor. HAE is frequently confused with angioedema (AE), and little is known about emergency department (ED) or hospital utilization by patients with attacks in the United States. We examined hospitalizations and ED utilization for HAE...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/aap.2010.31.3403
更新日期:2010-11-01 00:00:00
abstract::Barbiturates, a class of medications commonly used as antiepileptics and sedatives, are known to cause adverse reaction, with the most commonly reported immune-mediated reactions being anticonvulsant hypersensitivity syndrome. Other types of allergic reactions such as immediate hypersensitivity reactions also can occu...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:
更新日期:2004-07-01 00:00:00
abstract:BACKGROUND:Anaphylaxis is increasingly reported in infancy. Diagnosis and management of anaphylaxis is difficult, and data are limited in infants. The aim of the present study was to determine the clinical course and management strategies used for anaphylaxis in infancy. METHODS:Patients attending to our clinic and wh...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/aap.2017.38.4009
更新日期:2017-01-01 00:00:00
abstract::Measurement of exhaled nitric oxide levels (eNO) from asthmatic patients is a noninvasive marker of airway inflammation in both adults and children and has been used as an outpatient measure of asthma control. We examined eNO in acute asthma exacerbations and how it is affected by treatment in the emergency departmen...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,随机对照试验
doi:10.2500/aap.2012.33.3613
更新日期:2012-11-01 00:00:00
abstract::Background: Although clinical trials documented omalizumab's efficacy in U.S. patients with chronic idiopathic urticaria (CIU), the real-world evidence on its long-term effectiveness is lacking. Objective: To assess omalizumab use and the long-term response in a large sample of U.S. real-world patients. Methods: Patie...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/aap.2019.40.4236
更新日期:2019-09-01 00:00:00
abstract::Aspergilloma and invasive aspergillosis have been reported in HIV-infected individuals. Allergic Bronchopulmonary Aspergillosis (ABPA) is a lung disease marked by a hypersensitivity response to inhaled aspergillus species, most commonly Aspergillus fumigatus (Af). This manifestation of Af has previously not been repor...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/108854100778249051
更新日期:2000-11-01 00:00:00
abstract:BACKGROUND:A history of penicillin allergy is associated with an increased risk of nosocomial infections because patients are exposed to non-beta lactam antibiotics. Ruling out inaccurate penicillin allergy during hospitalization decreases prescription of beta lactam antibiotics. However, the utilization of penicillin ...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/aap.2018.39.4118
更新日期:2018-05-01 00:00:00
abstract::Treatment guidelines recognize the importance of achieving and maintaining asthma control. This study was designed to assess the prevalence of asthma control in a representative U.S. population. A survey regarding asthma and associated symptoms was sent to a representative national sample of 134,401 households managed...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/aap.2009.30.3276
更新日期:2009-09-01 00:00:00
abstract:Background:Bronchial asthma and rhinitis are among the most common diseases in children and frequently coexist in the patient. The primary aim of anti-asthmatic therapy is disease control. Several questionnaires can be used in pediatrics to assess asthma control and the Children Asthma Control Test (C-ACT) is one of th...
journal_title:Allergy and asthma proceedings
pub_type: 信件
doi:10.2500/aap.2019.40.4219
更新日期:2019-05-01 00:00:00
abstract::Occupational immunologic lung disease is characterized by an immunologic response in the lung to an airborne agent inhaled in the work environment and can be subdivided into immunologically mediated occupational asthma (OA) and hypersensitivity pneumonitis (HP). Irritant-induced OA, a separate nonimmunologic entity, ...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:10.2500/aap.2012.33.3550
更新日期:2012-05-01 00:00:00
abstract::Allergic diseases reflect various pathways of T lymphocyte inflammation and largely comprise T helper (Th) 2-associated processes. Recent investigations have identified pathways involved in promoting Th2 responses. Additionally, novel T-cell subtypes, each with its own distinct cytokine profile, contribute to the hete...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:10.2500/aap.2011.32.3428
更新日期:2011-03-01 00:00:00
abstract::Percutaneous skin testing to determine allergies is usually read 15-20 minutes after placement, but the time to reading may be prolonged because of clinic duties or emergencies. The objective of the study was to compare skin-prick testing (SPT) wheal and flare reactions at 10, 30, and 40 minutes with the standard 20 m...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/aap.2011.32.3436
更新日期:2011-05-01 00:00:00
abstract::With the widespread recognition that T-cells are the key mediators of psoriasis, current treatment strategies have focused on reducing the population of these cells or modulating their activity through the use of immunosuppressive treatments such as methotrexate, cyclosporine, and psoralens plus ultraviolet A radiatio...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:
更新日期:2006-03-01 00:00:00
abstract::Background: Asthma is a chronic and complex lung disease that is not completely understood. It involves airway inflammation, reversible airflow obstruction, and bronchial hyperresponsiveness. The most common symptoms are recurrent wheezing, chest tightness, shortness of breath, and coughing. Objective: The Asthma Insi...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,多中心研究
doi:10.2500/aap.2018.39.4180
更新日期:2018-11-16 00:00:00
abstract::The atopy patch test (APT) was first reported in 1895 by the German dermatologist, Jadassohn and was used for evaluation of contact dermatitis. The first documented epicutaneous application of aeroallergens was by Rostenberg and Sulzbergen in 1937. Although others including Mitchell and Platts-Mills, further described...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,评审
doi:10.2500/aap.2014.35.3797
更新日期:2014-11-01 00:00:00
abstract:PURPOSE:An association between childhood allergic disease and parental psychological disorders has been reported. However, little is known about the relationship between childhood allergic disease and maternal depression. This study was performed to determine if there is an association between childhood allergic diseas...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章
doi:10.2500/aap.2017.38.4059
更新日期:2017-07-01 00:00:00
abstract::Forced oscillometry (FOT) has been reported as a simple method to detect respiratory resistance (Rrs) changes. The aim of this study was to evaluate FOT capacity to detect children with clinical characteristics of asthma in a school setting. One thousand thirty children, 6-7 years old, were investigated by questionnai...
journal_title:Allergy and asthma proceedings
pub_type: 杂志文章,多中心研究
doi:10.2500/aap.2007.28.2965
更新日期:2007-03-01 00:00:00