Pathogenesis of Chronic Sinusitis in Relationship to Tobacco Smoke Exposure

NCT01179139 | Completed

• 1 other identifier: 2003P002050
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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 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

Keywords

CRS

Outcome Measures

Primary Outcomes (1)

• Comparison of innate immune and inflammatory factor mRNA expression

  To compare the expression profile of innate immune and inflammatory factor mRNA expression in the epithelial and glandular tissue compartments in 8 patients with refractory CRS versus 8 healthy control nasal middle turbinates (HC) using microarray.

  0hr

Secondary Outcomes (1)

• Characterization of bacterial microbial community

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Study Arms (2)

Healthy Control

ACTIVE COMPARATOR

Other: Biopsy

CRS

EXPERIMENTAL

Other: Biopsy

Interventions

Biopsy OTHER

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.

CRS; Healthy Control

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Eye and Ear Infirmary: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Daniel Hamilos, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: August 11, 2010
• Study Start: December 1, 2003
• Primary Completion: July 1, 2010
• Study Completion: April 1, 2011
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

US (1)