The Effect of EDS-FLU on Objective and Patient-Reported Subjective Outcomes for Patients with Chronic Rhinosinusitis with Nasal Polyps.

BACKGROUND: Exhalation delivery system with fluticasone (EDS-FLU) delivers medication high and deep in the nasal passages and has been shown to reduce nasal polyp (NP) grade, an objective measure of efficacy, and to yield clinically meaningful improvements on subjective measures of symptoms in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). OBJECTIVES: To better characterize EDS-FLU treatment, we analyzed responder rates for four outcome measures used in the EDS-FLU pivotal trials, in the overall study population as well as in subgroups of patients with or without prior sinus surgery or prior use of a standard intranasal corticosteroid spray (INS). METHODS: Data were pooled from two randomized, 24-week (16-week, double-blind + 8-week, open-label), placebo-controlled studies (NAVIGATE I and II). Results for patients receiving EDS-FLU (186 µg [n = 161] or 372 µg [n = 160]) or EDS-placebo (n = 161) twice daily during the double-blind phase are described. Responder criteria included NP grade reduction (≥1-point), 22-item Sino-Nasal Outcome Test (SNOT-22) reduction (>12-points), Patient Global Impression of Change (PGIC) (much/very much improved), and congestion score improvement (>0.5-points). RESULTS: More patients in the EDS-FLU group responded to each of the four responder criteria compared with EDS-placebo. More patients receiving EDS-FLU responded to ≥ 1 criterion compared with EDS-placebo at week 4 (82.7% and 60.4%, respectively) and week 16 (95.7% and 80.3%, respectively). Patients responded similarly irrespective of prior sinus surgery or prior INS use. Patient-reported outcome measures showed earlier responses than NP scores. CONCLUSIONS: Meaningful improvements were seen across multiple response criteria with EDS-FLU, suggesting that the broad treatment effect of EDS-FLU includes objective reduction in polyp grade and improvements in several patient-reported outcomes. TRIAL REGISTRATION: ClinicalTrials.gov (NAVIGATE I: NCT01622569 and NAVIGATE II: NCT01624662).

Update on the diagnostic considerations for neurogenic nasal and sinus symptoms: A current review suggests adding a possible diagnosis of migraine.

BACKGROUND: Treatment of rhinosinusitis (RS) is one of the leading reasons for prescriptions of antibiotics, although they often fail to provide symptomatic relief. Appropriately diagnosing and treating patients presenting with RS for whom antibiotic therapy has failed or who have normal CT findings is a controversial topic. One explanation is that what these patients are experiencing is misinformation from the trigeminal nerve and autonomic nervous system. Midfacial pain and pressure with rhinorrhea and nasal congestion do not represent an infectious, or even inflammatory, condition within the sinus or nasal cavities, but a mirage that is best treated as a migraine variant. Observations Although there is not enough research to definitively prove this alternate etiology, we are reaching a tipping point where the clinical implications, real-world experience, and evolving literature support this possible alternate etiology. Four key factors support a midfacial migraine that mimics RS: 1) Pathophysiology: current pathophysiology literature offers a model of how migraine attacks could replicate clinical presentations of RS; 2) Clinical presentation: patients with infectious RS and midfacial migraine have similar symptomatic presentation, similar demographics, but poorly correlated radiological information; 3) Diagnosis: clinical studies support the proposition that there are alternative diagnostic tools for distinguishing patients with midfacial migraine; and 4) Prognosis: Select RS patients show significant improvement with migraine treatment. CONCLUSIONS: We encourage medical professionals to consider migraine disease as a form of sensory misinformation and as a possible etiology of RS complaints. Clinicians can ask validated questions to determine if possible migraine could be an underlying cause, and there are standard preventative treatments for migraine that could alleviate patient symptoms. Dysfunctional vasomotor activity may be the root of the disturbances, particularly when antibiotic therapy fails and CT findings are discordant with symptoms. Until there is a diagnostic test for migraine, clinicians need to question a patient's self-diagnosis of rhinosinusitis. More research is needed to definitively answer this important question.

What do we know about rhinogenic headache? The otolaryngologist's challenge.

Sinus headache is a common presenting complaint in the otolaryngology office. Although most patients with this presentation are found to have migraine headache, many do not, and others fail therapy. This review focuses on the current understanding of nonneoplastic rhinogenic headache: headaches that are caused or exacerbated by nasal or paranasal sinus disease or anatomy. The literature regarding this topic is reviewed, along with a review of surgical series seeking to correct these abnormalities and the outcomes obtained with intervention. Suggestions are provided regarding patient diagnosis and management, and options for intervention are reviewed.

Migraine and allergy: a review and clinical update.

Migraine and allergy are both common diseases. Many patients suffer from both, and the vast majority of patients with "sinus headache" complaints are found to have migraine, making migraine identification important to allergists. This review addresses the possibility that allergy and migraine are comorbid conditions, focusing on epidemiology, shared biochemical pathways, and underlying mechanisms. Therapeutic implications of this possible relationship have been the subject of several recent studies, making a review of this association timely and prudent.

Allergy and migraine: is there a connection?

PURPOSE OF REVIEW: In the last 10 years, otolaryngologists and allergists have become increasingly aware of migraine headaches in their practices. This is partially due to a better understanding of the high incidence of migraine and a realization that the majority of patients presenting as 'sinus headache' are actually suffering from migraine headaches. Considering that the incidence of migraine is approximately 20% in women and 6% in men and that 10-30% of people have allergies (US Department of Health and Human Services. Evidence Report/Technology Assessment No. 54; May 2002. AHRQ Publication No. 02-E024. pp. 1-198), there is obviously a large population of patients who suffer from both conditions. The question then arises that are migraine and allergy comorbid conditions, or is any association between the two a random occurrence? RECENT FINDINGS: The present study addresses this association, which has remained controversial for over 100 years. Newer studies focusing on familial trends, shared biochemical pathways and underlying mechanisms are presented. RELEVANCE: This study will provide a foundation to support future clinical studies.

Sinus CT scan findings in "sinus headache" migraineurs.

OBJECTIVE: To evaluate the sinus CT scan findings in "sinus headache" migraineurs, and to compare the findings to nonmigraine "sinus headache" patients. BACKGROUND: The majority of patients presenting with "sinus headache" satisfy the International Headache Society (IHS) criteria for migraine headache. Few studies have correlated the rhinologic complaints and computed tomography (CT) findings in these patients. METHODS: Thirty-five patients with "sinus headache" were evaluated prospectively and referred for CT of the paranasal sinuses. The CT scans were assessed for sinus abnormality (recorded as a Lund-Mackay [L-M] score) and were analyzed for concha bullosa and septal deviation. The findings in the migraine cohort were compared with the nonmigraine "sinus headache" patients. FINDINGS: Twenty-six patients (74.3%) satisfied the IHS criteria for migraine. The mean CT scan L-M score did not differ significantly between the migraine (2.07) and nonmigraine cohort (2.66). Five of the migraine group had substantial sinus disease radiographically (with L-M scores of 5 or above). Concha bullosa of at least 1 middle turbinate was more common in the nonmigraine cohort. An analysis of the sidedness of the headaches, sinus disease, concha bullosa, and/or septal deviation is presented. CONCLUSIONS: The majority of "sinus headache" patients satisfy the IHS criteria for migraine. Surprisingly, these patients often have radiographic sinus disease. This raises the possibility of selection bias in otolaryngology patients, inaccurate diagnosis, or radiographic sinus disease and migraine as comorbid conditions. Positive migraine histories apparently do not obviate the need for a thorough ENT workup, possibly including CT scanning.

Sinus headache, migraine, and the otolaryngologist.

"Sinus headache" is a common complaint in the otolaryngology office. Recent literature has shown that the majority of patients with this complaint satisfy the diagnostic criteria for migraine. This review article presents an overview of the sinus headache literature, with emphasis on the incidence, identification, and treatment of migraine headache for the otolaryngologist.

Are nasal steroids safe?

Nasal steroids have emerged as an integral part of rhinitis management. Most studies have shown no evidence of significant hypothalamic-pituitary-adrenal axis suppression from nasal steroid use, at least based on dynamic testing. Bone mineral density loss, glaucoma, and cataract formation are risks associated with systemic steroids, but reports with nasal steroid use are few. Growth retardation has been seen with some nasal steroids, but not others, based on stadiometric growth studies. Further studies are certainly needed to resolve this issue. Nasal steroids, in general, have an excellent safety record.