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1.  A proposed model to study immunologic changes during chronic rhinosinusitis exacerbations: Data from a pilot study 
Background:
One way to gain insight into the pathophysiology of chronic rhinosinusitis (CRS) is to study the immunologic changes that occur with exacerbation. This study describes the immunologic changes during CRS exacerbation
Methods:
We performed a prospective study to investigate the immunologic changes seen during exacerbation of CRS with nasal polyposis. We recruited adult subjects who met clinical criteria for CRS with sinus CT scan within the past 5 years with Lund-Mackay score of >5 and nasal polyps. Subjects underwent a baseline visit with collection of nasal secretion and nasal wash. With acute worsening of symptoms, subjects underwent 6 near-consecutive-day collections and one follow-up collection 2 weeks later. IL-6, IL-33, eosinophil major basic protein (MBP), eosinophil-derived neurotoxin (EDN), myeloperoxidase (MPO), and uric acid were measured on the nasal samples from each visit.
Results:
A total of 10 subjects were recruited and 9 had acute worsening of CRS during the study period. Eight of the nine subjects were women and ages ranged from 26 to 56 years. At baseline, most inflammatory parameters were low and eight of the nine subjects were on intranasal corticosteroids. Compared with baseline measurements, IL-6, MBP, MPO, EDN, and uric acid were significantly elevated during CRS exacerbation. Levels of IL-6 and MBP (r = 0.47) levels as well as IL-6 and MPO (r = 0.75) were both significantly correlated (p < 0.01).
Conclusion:
Prospective study of CRS exacerbations is feasible and provides insights into the immunologic mechanisms of CRS.
doi:10.2500/ajra.2013.27.3850
PMCID: PMC3610944  PMID: 23562196
Chronic sinusitis; eosinophil-derived neurotoxin; eosinophil major basic protein; exacerbation; interleukin-6; interleukin-33; myeloperoxidase; nasal polyposis; nasal secretion; uric acid; viral upper respiratory tract infection
2.  Assessment of synthetic glucocorticoids in asthmatic sputum 
Allergy & Rhinology  2011;2(1):33-35.
Nonadherence with anti-inflammatory treatment is a frequent cause of continued symptoms in asthmatic patients. Clinical assessments including patient-reported medication administration may provide the asthma specialist incomplete information regarding actual adherence to anti-inflammatory medications. The objective of this report was to describe the first case where adherence to inhaled asthma therapy was assessed by direct analysis of glucocorticoids in induced sputum. The patient's blood, urine, and sputum were tested for synthetic corticosteroids using mass spectrometry. To evaluate a clinical suspicion of poor adherence, sputum, urine, and blood were used to assess for current compliance to medication use. We report a case where asthma specialists attributed poorly controlled asthma to nonadherence to medical therapy. After modification of the medical regimen, adherence with oral and inhaled steroids was assessed—via examination of the urine, blood, and sputum. Direct analysis of glucocorticoids in sputum is feasible and in theory could provide a novel tool to document current medication adherence. Concomitant assessment of glucocorticoids and eosinophils in the same induced sputum specimen could provide insight into possible steroid resistance in select referral patients with difficult asthma.
doi:10.2500/ar.2011.2.0002
PMCID: PMC3390127  PMID: 22852112
Adherence; asthma; budesonide; drug monitoring; fluticasone propionate; methylprednisolone; prednisolone; prednisone; steroids; steroid dependent
3.  Blood and Sputum Eosinophil Levels in Asthma and Their Relationship to Sinus Computed Tomographic Findings 
OBJECTIVE
To investigate the relationship among blood and sputum eosinophil levels, sinus mucosal thickening, and osteitis in patients with asthma.
PATIENTS AND METHODS
We conducted an observational study of 201 patients with asthma who underwent sinus computed tomographic (CT) imaging and induced sputum analysis at Mayo Clinic's site in Rochester, MN, from November 1, 2000, through December 31, 2005. Sinus CT scans were reviewed by an investigator blinded to patients' identity and chart information (J.B.H.) to assess for mucosal thickening. Each scan was assigned a CT score based on the Lund-Mackay staging scale. Approximately 20% of the scans were reviewed at random by a radiologist (N.G.C.) to ensure quality control. Bone changes consistent with osteitis were ascertained from radiology reports. Lung function was measured, and sputum was analyzed by conventional methods.
RESULTS
Sinus CT scans revealed abnormalities in 136 (68%) of the 201 study patients. Severe mucosal thickening (CT score, ≥12) was found in 60 patients (30%) and osteitis in 18 patients (9%). There was a positive correlation between CT scores and eosinophil levels in both peripheral blood (ρ=0.45; 95% confidence interval, 0.33–0.56; P<.001) and induced sputum (ρ=0.46; 95% confidence interval, 0.34–0.57; P<.001). Further, elevated blood and sputum eosinophil levels were associated with the presence of osteitis on CT scan and previous sinus surgery.
CONCLUSION
Blood and sputum eosinophil levels in patients with asthma are directly correlated with sinus mucosal thickening and are associated with osteitis, lending further support to the hypothesis that asthma and chronic rhinosinusitis are mediated by similar inflammatory processes.
PMCID: PMC2824564  PMID: 18533084
4.  Reduced Immunoglobulin M Is Associated with Sinus Mucosal Thickening, Osteitis and Sinus Surgery in Patients with Common Variable Immunodeficiency 
Background
Although common variable immunodeficiency (CVID) is associated with sinopulmonary disease, there are no previous systematic evaluations comparing computed tomographic (CT) sinus imaging with immunoglobulin measurements in patients with this condition.
Methods
We performed a retrospective review by a blinded observer using the Lund-Mackay numerical scoring scale as well as a visual scale for remodeling changes in the paranasal sinus bone on CT scans in CVID patients.
Results
The sinus CT scans of 19 subjects (9 males, 10 females; median age at diagnosis 34 years) are described. There was an inverse relationship between serum IgM and sinus mucosal thickening as described by the Lund-Mackay scale (R = −0.6398; p = 0.0032). Osteitis of the paranasal sinus bone was almost exclusively found in patients with a reduced serum IgM level of less than 25 mg/dl (p = 0.0074).
Conclusion
This is the first study to show that sinus mucosal thickening on CT in patients with CVID is inversely related to serum IgM levels.
doi:10.1159/000260088
PMCID: PMC3202961  PMID: 19940510
Common variable immunodeficiency; Chronic sinusitis; Immunoglobulin M
5.  Efficacy and Safety of a New 20% Immunoglobulin Preparation for Subcutaneous Administration, IgPro20, in Patients With Primary Immunodeficiency 
Journal of Clinical Immunology  2010;30(5):734-745.
Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5–72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs.
doi:10.1007/s10875-010-9423-4
PMCID: PMC2935975  PMID: 20454851
Subcutaneous immunoglobulin (SCIG); primary immunodeficiency; local tolerability; serum IgG trough levels; L-proline; home infusion therapy
6.  Incidence and Temporal Trends of Primary Immunodeficiency: A Population-Based Cohort Study 
Mayo Clinic Proceedings  2009;84(1):16-22.
OBJECTIVE: To determine the incidence and temporal trends of primary immunodeficiency diseases (PIDs) and examine whether an association exists between delayed diagnosis and increased morbidity.
PATIENTS AND METHODS: We performed a historical cohort study to describe the epidemiology of PIDs in Olmsted County, Minnesota, during a 31-year period from January 1, 1976, through December 31, 2006, using the Rochester Epidemiology Project. Incidence and trends over time, presence of comorbid conditions, and trends in management were determined.
RESULTS: During the 31-year study period, 158 new cases of PIDs were diagnosed, with an overall incidence rate of 4.6 per 100,000 person-years. The rate of PIDs from 2001 through 2006 (10.3 per 100,000 person-years) was nearly 5 times higher than that from 1976 through 1980 (2.4 per 100,000 person-years). The associations between continuous variable(s) and categorical outcome(s) were assessed by using the Wilcoxon rank sum test. Longer delay in diagnosis was significantly associated with recurrent sinusitis (P<.001), recurrent pneumonia (P=.03), and subsequent treatment with immunoglobulins (P<.001). On the basis of Kaplan-Meier survival estimates, the proportion of patients surviving at 10 years after diagnosis was 93.5% (95% confidence interval, 85.9%-97.1%). However, older age at diagnosis was significantly associated with mortality (P=.01).
CONCLUSION: This is one of the first population-based studies to examine the temporal trends of PIDs. The incidence of PIDs increased markedly between 1976 and 2006. In this cohort, a delay in diagnosis was common and was associated with increased morbidity. Despite substantial morbidity, most patients with PIDs can expect a normal life span.
The incidence of primary immunodeficiency diseases increased markedly between January 1976 and December 2006; this study found that a delay in diagnosis was common and was associated with increased morbidity, but most patients with primary immunodeficiency diseases can expect a normal life span.
PMCID: PMC2630110  PMID: 19121249
7.  Incidence and Temporal Trends of Primary Immunodeficiency: A Population-Based Cohort Study 
OBJECTIVE
To determine the incidence and temporal trends of primary immunodeficiency diseases (PIDs) and examine whether an association exists between delayed diagnosis and increased morbidity.
PATIENTS AND METHODS
We performed a historical cohort study to describe the epidemiology of PIDs in Olmsted County, Minne-sota, during a 31-year period from January 1, 1976, through December 31, 2006, using the Rochester Epidemiology Project. Incidence and trends over time, presence of comorbid conditions, and trends in management were determined.
RESULTS
During the 31-year study period, 158 new cases of PIDs were diagnosed, with an overall incidence rate of 4.6 per 100,000 person-years. The rate of PIDs from 2001 through 2006 (10.3 per 100,000 person-years) was nearly 5 times higher than that from 1976 through 1980 (2.4 per 100,000 person-years). The associations between continuous variable(s) and categorical outcome(s) were assessed by using the Wilcoxon rank sum test. Longer delay in diagnosis was significantly associated with recurrent sinusitis (P<.001), recurrent pneumonia (P=.03), and subsequent treatment with immunoglobulins (P<.001). On the basis of Kaplan-Meier survival estimates, the proportion of patients surviving at 10 years after diagnosis was 93.5% (95% confidence interval, 85.9%–97.1%). However, older age at diagnosis was significantly associated with mortality (P=.01).
CONCLUSION
This is one of the first population-based studies to examine the temporal trends of PIDs. The incidence of PIDs increased markedly between 1976 and 2006. In this cohort, a delay in diagnosis was common and was associated with increased morbidity. Despite substantial morbidity, most patients with PIDs can expect a normal life span.
PMCID: PMC2630110  PMID: 19121249

Results 1-7 (7)