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A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
Rochester, MN
Primary Objective: To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in patients with bilateral nasal polyposis (NP). In addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses will be also a coprimary objective. Secondary Objectives: - To evaluate the efficacy of dupilumab in improving total symptoms score (TSS). - To evaluate the efficacy of dupilumab in improving sense of smell. - To evaluate the efficacy of dupilumab in reducing CT scan opacification of the ...
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A Study to Determine the Effectiveness and Safety of Benralizumab for Patients with Severe Nasal Polyposis
Rochester, MN
The purpose of this study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy; i.e, current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids.
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Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
Scottsdale/Phoenix, AZ
Primary Objective:
To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyposis score (NPS) in patients with bilateral nasal polyposis (NP). In addition for Japan, reduction in computed tomography (CT) scan opacification of the sinuses will be also a co-primary objective.
Secondary Objectives:
- To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).
- To evaluate the efficacy of dupilumab in improving sense of smell.
- To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (Primary objective for Japan).
- To evaluate ability of ...
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Analysis of Group 2 Innate Lymphoid Cells in Peripheral Blood
Rochester, MN
The primary objective of this study is to investigate the contribution of group 2 innate lymphoid cells (ILC2s) to the immunologic mechanisms of chronic airway diseases.
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A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma
Rochester, MN
The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during 24-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps.
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Mobile Device Surveying for Chronic Rhinosinusitis with Nasal Polyposis
Rochester, MN
The purpose of this study is to gather periodic quality of life data using the validated SNOT-22 protocol and/or other validated metrics using a free iPhone application for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP).
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A Study to Evaluate the Effect of Medical Intervention on Sinonasal Inflammation in Patients with Chronic Sinusitis, Nasal Polyps and Positive Sinus Culture
Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to compare change in SNOT-22 score in patients who received medication therapy such as oral antibiotics, topical antibiotics, oral corticosteroids, topical corticosteroids, leukotriene receptor antagonist, and interleukin 5 receptor antagonist following endoscopic sinus surgery versus control in patient with chronic sinusitis with nasal polyps and a positive culture.
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Determining Prevention of Nasal Polyp Recurrence in AERD Patients Using Aspirin
Rochester, MN
The purpose of this study is to investigate the mechanism through which aspirin works for the prevention of nasal polyp recurrence in AERD patients, while comparing two aspirin doses: 325 mg once-daily or 650 mg twice daily dose of aspirin.
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Immune Changes in Chronic Rhinosinusitis with Nasal Polyps and Aspirin Sensitivity After Aspirin Desensitization
Rochester, MN
The objectives of this study are to determine longitudinal effects of aspirin desensitization on circulating immune cells in Aspirin Exacerbated Respiratory Disease (AERD) subjects, and to compare effects of sinus surgery on circulating immune cells in patients with AERD compared to patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Immune cells in nasal polyp tissue removed at the time of endoscopic sinus surgery will also be compared to the profile of circulating immune cells before and after endoscopic sinus surgery and, for some subjects, after aspirin desensitization.