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Pathogenesis of Chronic Sinusitis in Relationship to Tobacco Smoke Exposure

NCT01179139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2018-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Rhinosinusitis

Interventions

OTHER

Biopsy

Percutaneous 2-3 mm biopsies of middle turbinate mucosae and nasal polyps will be obtained with 5 mm Thrucut® (Smith \& Nephew, Memphis, TN) biopsy forceps. Generally, 2-3 specimens will be obtained from each side as in previous studies. Healthy controls and subjects with CRS without NP will have biopsies from both middle turbinates. Subjects with CRS with NP will have two nasal polyp biopsies and one middle turbinate biopsy.

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Daniel Hamilos, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2010-07-31
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01179139 on ClinicalTrials.gov