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Biomedical subjects

Bradley F Marple

Publications and source records attributed to Bradley F Marple.

At least 19 recordsLinked to original sources

Allergic fungal rhinosinusitis: diagnosis and management.

PURPOSE OF REVIEW: The proper diagnosis and treatment of allergic fungal rhinosinusitis remain controversial. We discuss recent additions to the literature regarding diagnosis and treatment of this condition. RECENT FINDINGS: There is considerable overlap in the clinical features of allergic fungal rhinosinusitis and other forms of eosinophilic mucin chronic rhinosinusitis. Type 1 hypersensitivity and characteristic computed tomographic findings may have predictive value for a final diagnosis of allergic fungal rhinosinusitis, patients with which are more likely to have bony erosion than patients with other forms of chronic rhinosinusitis. The decreases in orbital volume associated with expansive allergic fungal rhinosinusitis disease may spontaneously improve after successful treatment. Most patients have detectable fungal-specific IgE in their so-called allergic mucin. Elevated levels of fungal-specific IgG3 are a consistent finding in patients with allergic fungal rhinosinusitis and eosinophilic mucin chronic rhinosinusitis. Antifungal treatment is still considered a treatment option, but further study is needed. SUMMARY: Type 1 hypersensitivity to fungal antigens helps to distinguish allergic fungal rhinosinusitis from other forms of eosinophilic mucin chronic rhinosinusitis. Bony erosion and orbital expansion giving rise to proptosis are prominent features of allergic fungal rhinosinusitis. Advances in medical treatment will require prospective and controlled trials.

Humans↗

Rhinosinusitis: developing guidance for clinical trials.

The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication "Rhinosinusitis: Establishing definitions for clinical research and patient care" and provides templates for clinical trials in antimicrobial, anti-inflammatory, and symptom-relieving therapies for the following: (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.

Chronic Disease↗

Acute bacterial rhinosinusitis: a review of U.S. treatment guidelines.

Acute bacterial rhinosinusitis (ABRS) is a common complication of viral upper respiratory tract infections and is associated with a significant socioeconomic burden. Guidelines for the diagnosis and management of ABRS have been produced in association with a number of societies in the United States; these guidelines aim to promote the rational selection of antibiotic therapy to optimize clinical outcomes while minimizing the potential for selection of antibiotic resistance. This article provides an overview of current U.S. guidelines for the treatment of ABRS, focusing on the impact of antibiotic resistance on treatment options.

Anti-Bacterial Agents↗

Rhinosinusitis: Developing guidance for clinical trials.

The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication, "Rhinosinusitis: Establishing definitions for clinical research and patient care" and provides templates for clinical trials in antimicrobial, anti-inflammatory, and symptom-relieving therapies for the following: (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.

Chronic Disease↗

Sinus surgery: indications and techniques.

Functional endoscopic sinus surgery (FESS) is a recent addition to the treatment armamentarium of sinus disease. Performed through the nasal cavity using endoscopes and inciting no external scars, these advantages have renewed an interest in the surgical intervention of various sinus diseases. With minimal risk and complications associated with FESS, the temptation exists to lower the threshold and expand the indications for sinus surgery. However, regardless of the reduced risk, FESS should be pursued only when the goals are attainable and the limitations of surgery are understood for each specific disease. Chronic rhinosinusitis (CRS), affecting more than 31 million people a year, represents a treatment challenge. The challenge stems from evidence that CRS can result from different etiologies including bacteria, virus, fungi, superantigens, and unfavorable anatomy. With an unclear pathogenesis, success of medical therapy is often limited. Individuals failing medical therapy are candidates for surgical intervention. The controversy, indications, and goals of surgery in CRS are reviewed. Other indications for FESS are less controversial. Nasal polyps, which can interfere with medical therapy and obstruct airflow, often require surgical intervention. In addition, recent data has suggested a link between surgery and a reduction in inflammatory markers. Repair of skull base defects, and resection of benign and limited malignant nasal masses are also indications for FESS. This article reviews the indications of sinus surgery. In addition, it addresses some of the controversies, limitations, and advances in FESS.

Chronic Disease↗

Optimal duration of allergic rhinitis clinical trials.

OBJECTIVE: Guidelines have been published by the Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) for the conduct of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) studies. These guidelines have differences regarding the duration of such trials: the FDA suggests 2 weeks for SAR and 4 weeks for PAR but the EMEA suggests 2 to 4 weeks for SAR and 6 to 12 weeks for PAR trials. In the interest of global harmonization, it would be desirable to have a uniform duration of such trials so that investigators, internationally, would be able to readily compare results for various types of treatments based on a single standard. Therefore, we performed an evidence-based review to answer the clinical question, What is the optimal duration for SAR and PAR clinical trials? METHODS: We performed a MEDLINE search of the published literature from 1995 to the present. We used appropriate search terms, such as allergic rhinitis, seasonal allergic rhinitis, perennial allergic rhinitis, SAR, and PAR, to identify pertinent articles. These articles were reviewed and graded according to the evidence quality. RESULTS: After an initial screening of more than 300 articles, 138 articles were analyzed thoroughly. No study specifically addressed the question of the optimal duration of SAR or PAR clinical trials. CONCLUSIONS: We conclude that the current FDA (draft) guidelines calling for a study length of 2 weeks for the assessment of drug efficacy for SAR and 4 weeks for the study of drug efficacy in PAR are appropriate and that longer study periods are not likely to add meaningfully to the assessment of drug efficacy.

Clinical Trials as Topic↗

Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis.

BACKGROUND: A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR). OBJECTIVE: To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo in patients with SAR. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 565 patients aged 12 to 80 years were randomized to receive 0.4% or 0.6% olopatadine or placebo, 2 sprays per nostril twice daily for 2 weeks. Patients evaluated morning and evening reflective and instantaneous nasal symptoms (sneezing, stuffy nose, runny nose, and itchy nose, which compose the total nasal symptom score [TNSS]) and ocular symptoms and completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RESULTS: Olopatadine spray (0.4% and 0.6%) was significantly superior to placebo for percentage change from baseline in overall reflective (P = .004 and P < .001, respectively) and instantaneous (P = .02 and P = .003, respectively) TNSSs. Also, 0.6% olopatadine was significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny and itchy nose, and itchy eyes; the instantaneous assessments of watery eyes; and the overall and all 7 domain scores of the RQLQ (P < .05). Olopatadine spray exhibited a safety profile comparable with that of placebo. CONCLUSIONS: Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs (reflective and instantaneous) and in quality-of-life variables in patients with SAR. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.

Administration, Intranasal↗

Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar.

BACKGROUND: A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR) to mountain cedar. OBJECTIVE: To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo nasal spray in patients with SAR to mountain cedar. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 677 patients aged 12 to 81 years were randomized to receive 0.4% or 0.6% olopatadine or placebo, 2 sprays per nostril twice daily for 2 weeks. Patients evaluated morning and evening reflective and instantaneous nasal symptoms (sneezing, stuffy nose, runny nose, and itchy nose, which compose the total nasal symptom score [TNSS]) and ocular symptoms. RESULTS: Olopatadine spray (0.4% and 0.6%) was statistically significantly superior to placebo for percentage change from baseline in overall reflective and instantaneous TNSSs. Also, 0.6% olopatadine was statistically significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny nose, itchy nose, stuffy nose, itchy eyes, and watery eyes. Olopatadine spray exhibited a safety profile comparable with that of placebo. CONCLUSIONS: Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs and individual symptoms, including congestion, itchy and runny nose, sneezing, and itchy and watery eyes, in patients with SAR to mountain cedar. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.

Administration, Inhalation↗

Effect of topical nasal steroid sprays on nasal mucosa and ciliary function.

PURPOSE OF REVIEW: This review was conducted to examine current evidence focusing on the effect of nasal steroid sprays on nasal ciliary function. RECENT FINDINGS: Review of current literature suggests that long term effects of topical corticosteroid nasal sprays are safe and fail to cause damage to local nasal structure and function. SUMMARY: The use of corticosteroid nasal sprays for the treatment of allergic rhinitis is widely accepted. Popularity of this class of medications is based on a well-established combination of efficacy, tolerability, and safety. Although current literature suggests that the use of intranasal steroids is indeed safe, increasing indications for prolonged administration continue to fuel debate regarding the long-term effect on local nasal structure and function. The purpose of this article is to review current literature addressing the effects of the components of local intranasal steroid sprays on the structure and function of the nasal mucosa.

Administration, Intranasal↗

Fungal rhinosinusitis: state-of-the-art diagnosis and treatment.

The past 30 years has been witness to a period of tremendous growth and innovation within the field of rhinology, facilitating a better understanding and improved management techniques for a variety of local and systemic conditions manifesting within the nose and paranasal sinuses. Of these disease states, the spectrum of conditions considered under the rubric of fungal rhinosinusitis best exemplifies modern rhinology's position as a truly multidisciplinary specialty. We review the classification of the various forms of fungal rhinosinusitis and their clinical presentations, radiologic findings, and treatment options.

Acute Disease↗

Allergic fungal rhinosinusitis.

The combination of nasal polyposis, crust formation, and sinus cultures yielding Aspergillus was first noted in 1976 by Safirstein, who observed the clinical similarity that this constellation of findings shared with allergic bronchopulmonary aspergillosis (ABPA). Eventually, this disease came to be known as allergic fungal rhinosinusitis (AFRS). As clinical evidence of AFRS accumulated, controversy regarding its etiology, pathogenesis, natural history, and appropriate treatment naturally emerged. Despite past and current efforts, many of these controversies remain incompletely resolved, but continuing clinical study has illuminated some aspects of the disease and has led to an improved understanding of AFRS and its treatment. In this article, we review current data and theories regarding the pathophysiology and clinical presentation of AFRS, as well as the roles of various surgical and nonsurgical forms of therapy.

Fungi↗

Rhinologic pharmacotherapy in rhinoplasty.

Rhinoplasty surgeons inevitably encounter therapeutic considerations in managing their patients, and a thorough understanding of nasal function, as well as of disorders of the nose and sinuses, is requisite for positive clinical outcomes. Patients suffering from allergic rhinitis are not precluded from undergoing rhinoplasty, whereas other disease processes may warrant an otolaryngologic evaluation before proceeding with surgery. A thorough medical history and examination elucidate sinonasal disease conditions that may not improve after septorhinoplasty but potentially could respond to pharmacologic therapy.

Acute Disease↗