Pathogenesis of Chronic Sinusitis in Relationship to Tobacco Smoke Exposure

Completed · Not applicable

Conditions studied: Chronic Rhinosinusitis

In brief

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.

Key facts

Study ID

NCT01179139

Run by

Massachusetts General Hospital

People needed

97

Starts

2003-12-01

Expected to finish

2011-04-01

Last updated by the study team

2018-05-18

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All of the subjects will satisfy the recently proposed definition for chronic sinusitis, i.e. having symptoms for at least 12 weeks with two or more of the following: anterior and/or posterior mucopurulent drainage, nasal congestion, or facial pain/pressure. Subjects must also have objective evidence of disease on rhinoscopic examination, consisting of (a) thick white or colored mucus from at least one sinus area, (b) edema of the middle meatus or ethmoidal area or (c) the presence of polypoid tissue in the nasal cavity or sinus areas. Sinus CT scans will not be obtained.

You may not qualify if…

• Subjects with current or past use of cigarettes. Subjects with a history suggestive of immune deficiency (i.e. those who have had > one pneumonia in the past 12 months or those with known immune deficiency) will be excluded. Subjects with a known history of cystic fibrosis, Kartagener's syndrome, immotile cilia syndrome, hypogammaglobulinemia, and individuals taking medications that alter clotting and those with bleeding disorders will also be excluded. Subjects who are pregnant or who have a history of fainting will also be excluded. Subjects who are pregnant, planning to become pregnant, or breastfeeding.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.