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Chronic Rhinosinusitis clinical trials

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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: NCT01084811 Recruiting - Clinical trials for Chronic Rhinosinusitis

Chronic Rhinosinusitis: Biochemical Markers and Biofilm

Start date: April 2010
Phase: N/A
Study type: Observational

The investigators will conduct a descriptive, prospective, three-armed study concerning the pathophysiology of chronic rhinosinusitis. In one part of the study the investigators want to investigate the presence of biofilm in patients with chronic rhinosinusitis both with and without nasal polyps compared with a control group of subjects without chronic rhinosinusitis. The investigators will also compare quality of life in the three groups and correlate disease severity in biofilm patients versus patients where biofilm was not present. The hypothesis here is that biofilm patients suffers a more severe disease. In the other arm of the study the investigators will compare the presence of different biochemical compounds in the three study groups. The investigators specifically want to investigate matrix metalloproteases and apoptosis-inhibitors with immunohistochemistry. The investigators may also add other compounds to our test-battery if interesting candidates surface in the literature during the inclusion period. The purpose of this part of the study is to investigate candidates for the development of nasal polyposis. The investigators plan to include 100 patients suffering from chronic rhinosinusitis with nasal polyps, and 100 patients with chronic rhinosinusitis without nasal polyps and 30 control subjects.

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: NCT01024075 Recruiting - Clinical trials for Chronic Rhinosinusitis

Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes

Start date: November 2009
Phase: Phase 4
Study type: Interventional

Dexamethasone added to sinufoam, which is placed in the ethmoid cavity at the completion of endoscopic sinus surgery, will improve sinonasal mucosal healing.

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.

NCT ID: NCT00899561 Recruiting - Clinical trials for Chronic Rhinosinusitis

Computed Tomography (CT) Score and Histopathology of the Middle Turbinate in Chronic Rhinosinusitis

CT
Start date: December 2008
Phase: N/A
Study type: Observational

In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology. Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant histopathologic changes in the middle turbinate mucosa of patients with chronic rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of 1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No osteomyelitic changes were seen in this study group. The investigators hypothesize that a comparison between the three groups of patients with chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show that the higher the CT staging, the greater the histopathologic changes of the middle turbinate. The investigators also expect to find osteomyelitic changes in the middle turbinate of patients with higher CT staging.

NCT ID: NCT00871286 Completed - Clinical trials for Chronic Rhinosinusitis

Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study

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

The purpose of this research study is to determine whether or not computed tomography (CT) scans performed on patients with symptoms of chronic rhinosinusitis (CRS) but without any physical signs of the disease will (1) prove to be less expensive in the treatment and evaluation as compared to current practices, (2) avoid the use of unnecessary antibiotic prescriptions, and (3) provide a more efficient way to diagnose conditions in patients who have had CRS ruled out as a cause. The investigators hypothesize that current guidelines, when applied to subjects with symptoms of CRS in the absence of physical signs may be associated with (1) increased unnecessary prescription of antibiotics, (2) delay in further essential workup, and (3) increased overall health care costs.