Status:
COMPLETED
Pathogenesis of Chronic Sinusitis in Relationship to Tobacco Smoke Exposure
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Massachusetts Eye and Ear Infirmary
Conditions:
Chronic Rhinosinusitis
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief 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 qu...
Detailed Description
Chronic sinusitis is one of the most prevalent chronic illnesses in the United States and a significant health concern in terms of public health care expenditure. We wish to learn more about pathogeni...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01179139
Start Date
December 1 2003
End Date
April 1 2011
Last Update
May 18 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114