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Chronic Rhinosinusitis clinical trials

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NCT ID: NCT01391910 Completed - Clinical trials for Chronic Rhinosinusitis

Response Shift in Sinus Surgery Outcomes

Start date: June 2011
Phase: N/A
Study type: Observational

The aims of the study are: 1)to assess pre and post-operative Quality of Life (QOL) as measured by the Sino-Nasal Outcomes Test(SNOT)-20 questionnaire and 2)determine the significance of response shift on treatment effect. This is a prospective cohort study. The investigators will recruit patients who are within a 6 month post-functional endoscopic sinus surgery (FESS) timeframe and completed a pre-operative SNOT-20. The investigators will ask subjects to complete two more SNOT-20 forms and a Transition Quality of Life (QOL) scale. The SNOT-20 forms will be labelled "pre" and "post" operative. The "pre" should be completed based on subject's memory of their condition prior to surgery and "post" based on how they feel now.

NCT ID: NCT01332136 Completed - Clinical trials for Chronic Rhinosinusitis

Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

Start date: April 2011
Phase: N/A
Study type: Observational

This research study will be completed by enrolling a prospective, observational cohort study to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This investigation will compare quality of life outcomes between each treatment type, as well as measure cellular and molecular markers of inflammation in the sinus mucosa, to create models that predict improvement in quality of life following treatment.

NCT ID: NCT01255566 Completed - Sinusitis Clinical Trials

Medical Therapy Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multi-institutional Study

Start date: August 2009
Phase: N/A
Study type: Observational

This investigation is a prospective, multi-institutional cohort study comparing the differences in health-related quality-of-life (HRQoL) improvements between subjects electing continued medical management for chronic rhinosinusitis and those electing medical management plus surgical intervention. Our hypothesis is 3 fold: 1. That patients electing continued medical management will have less disease severity as measured by CT and baseline HRQoL scores, 2. Patients undergoing medical management plus ESS for chronic rhinosinusitis will experience a larger improvement in health related quality of life (HRQoL)compared to patients electing medical management alone, and 3. Patients undergoing medical management plus ESS for chronic rhinosinusitis will use fewer antibiotics, systemic steroids, and miss fewer days of work/school compared to patients electing medical management alone.

NCT ID: NCT01254916 Completed - Clinical trials for Chronic Rhinosinusitis

The Sinonasal Outcome Test - 22, Validated for Danish Patients

Start date: October 2008
Phase: N/A
Study type: Observational

Introduction: Chronic rhinosinusitis (CRS) is a significant health problem increasing in both incidence and prevalence. It calls into attention consensus about diagnosing, assessing symptoms and treatment of patients with CRS. Therefore a validated Danish measure of health-related quality of life in sinonasal disease is needed. Method: The Sinonasal Outcome measure 22 (SNOT-22) was translated into Danish and reproducibility was evaluated by test-retesting 40 patients with CRS. The statistical analyses used, were Pearson´s correlation coefficient, Cronbach´s alfa, Kappa and Bland-Altman´s Plot. Reproducibility was also tested looking at subscales within the SNOT-22. Result: The results show good internal correlation with Cronbach´s alfa at 0.83 in the initial test and 0.92 in the retest. Pearson was 0.70 (p<0.001) revealing good correlation between the initial scores and the retests scores. Kappa was calculated for each item with a mean value of 0.61 showing substantial agreement. Paired t-test revealed no significant difference in the subscales. Conclusion: The Danish version of SNOT-22 is recommended for Danish clinicians and researches as a patient-reported measure of outcome in sino-nasal disorders such as rhinosinusitis and nasal polyposis.

NCT ID: NCT01205984 Completed - Children Clinical Trials

Systemic Methylprednisolone in Chronic Rhinosinusitis

Start date: July 2007
Phase: Phase 4
Study type: Interventional

The place of systemic corticosteroids in the treatment of children with chronic rhinosinusitis (CRS) remains unclear. We aimed to assess the effectiveness and tolerability of oral methylprednisolone (MP) as an anti-inflammatory adjunct in the treatment of CRS in children.Forty-eight children (age 6-17 years) with clinically and radiologically proven CRS were included. Patients were randomly assigned to either oral amoxicillin/clavulanate (AMX/C) and MP or AMX/C and placebo (P) twice daily for 30 days. Oral MP was administered for the first 15 days with a tapering schedule. Primary parameters were mean change in symptom and sinus computed tomography (CT) scan scores after treatment. Secondary study parameters were mean changes in individual symptom scores after treatment, relapse rate and tolerability. Forty-five patients completed the study, 22 received AMX/C and MP, and 23 AMX/C and P. Both groups demonstrated significant improvements in symptom and sinus CT scores, comparing baseline to end of the treatment (p<0.001). Methylprednisolone as an adjunct was significantly more effective than placebo in reducing CT scores (p=0.004), total rhinosinusitis symptoms (p=0.001) and individual symptoms of nasal obstruction (p=0.001), postnasal discharge (p=0.007), and cough (p=0.009). At the end of the treatment, 48% of the children in the P group still had abnormal findings in CT versus 14% in the MP group (p = 0.013). Therapy-related adverse events were not different between groups. Although insignificant, the incidence of clinical relapses was also less in the MP group (25%) compared to P group (43%) (p = 0.137). Oral MP is well tolerated and provides added benefit to treatment with antibiotics for children with CRS.

NCT ID: NCT01198912 Completed - Nasal Polyps Clinical Trials

Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial

DOXYPOSTOP
Start date: November 22, 2011
Phase: Phase 2
Study type: Interventional

This is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. The objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.

NCT ID: NCT01179139 Completed - Clinical trials for Chronic Rhinosinusitis

Pathogenesis of Chronic Sinusitis in Relationship to Tobacco Smoke Exposure

FAMRI
Start date: December 2003
Phase: N/A
Study type: Interventional

The purpose of the study is to better understand the causes of chronic rhinosinusitis (CRS)and to determine if being around secondhand cigarette smoke causes swelling in the sinuses. To answer this question, we are inviting healthy volunteers, volunteers with chronic sinusitis, and volunteers with chronic sinusitis with nasal polyposis to complete a questionnaire and undergo a series of tests. These tests will measure their allergies, their exposure to cigarette smoke and the swelling in their sinuses. We are asking you to take part because you are in one of these groups. About 166 people will take part in this research study. All subjects will be enrolled at Massachusetts General Hospital (MGH). The Flight Attendants Medical Research Institute (FAMRI) and the Harvard Clinical and Translational Science Center Harvard Catalyst) are paying for this study.

NCT ID: NCT01066104 Completed - Clinical trials for Chronic Rhinosinusitis

Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

Xolair CRS
Start date: December 2009
Phase: Phase 2
Study type: Interventional

The investigators are doing this research study to learn more about a drug called Xolair (omalizumab). The investigators want to see if it is an effective treatment for chronic rhinosinusitis (CRS). Specifically, the investigators want to see whether Xolair will make nasal polyps smaller and less thick, and relieve symptoms in people with CRS. Polyps are abnormal growths of tissue that can grow in the lining of your sinuses (the inside of your nose). The investigators also want to find out if it is safe to use (whether it causes side effects).

NCT ID: NCT01002313 Completed - Clinical trials for Chronic Rhinosinusitis

Effect of Prednisone onTregs and TH17

Start date: November 2009
Phase: Phase 1
Study type: Observational

The primary objective of this study is to see whether systemic corticosteroids (such as Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with CRS. Patients are taking prednisone as part of their routine medical care.

NCT ID: NCT00947986 Completed - Clinical trials for Chronic Rhinosinusitis

Mucociliary Clearance Time in Chronic Rhinosinusitis (CRS) Patients After Sinus Surgery

Start date: July 2009
Phase: N/A
Study type: Interventional

The investigators are looking at the effects of baby shampoo nasal irrigation on the movement of mucous in the nose in patients who have undergone sinus surgery for chronic sinus problems.