Chronic RhinosinusitisFAMRINCT01179139
Pathogenesis of Chronic Sinusitis in Relationship to Tobacco Smoke Exposure
A study testing Biopsy in people with Chronic Rhinosinusitis, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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 pathogenic factors causing or contributing to chronic sinusitis. One of these factors is secondhand smoke (SS) exposure. However, several other factors are involved, including allergic, environmental, genetic and microbiologic factors and in any given patient, several of these factors may be contributing to the disease. One of our goals is to see whether specific patterns of inflammatory cells, cytokines or chemokines exist that can differentiate these causative factors and to help us to better understand their individual contributions to the disease.
Several inflammatory cells, cytokines and chemokines are present in chronically inflamed sinus tissue, and we believe they form the basis for the disease process. At present, we know very little about what drives them into the sinus tissues. We believe that the types of inflammatory cells, cytokines and chemokines elicited in this disease depend on the inciting stimulus.
Cigarette smoke has well-documented deleterious effects on respiratory mucosa that could promote the development of chronic sinusitis. These include reduction in normal mucociliary function; increased nasal airway resistance; induction of mucin gene expression and induction of chronic inflammation. In the proposed study, we will extend our previous findings to investigate the relationships between SS exposure and these inflammatory markers and also examine the relationship of these cytokines to the expression of particular mucins.
Extracts of cigarette smoke have been shown to induce numerous other proinflammatory effects on respiratory epithelial cells either in vivo or in vitro. In this study we will analyze the gene expression of inflammatory markers in a nasal mucosal biopsy. Our intent is to study sinusitis rather than rhinitis. Nonetheless, we will examine nasal rather than sinus mucosa largely owing to the difficulties posed by obtaining samples directly from the sinuses. Furthermore, recent consensus reports have emphasized the importance of viewing sinusitis as a continuum of nasal and sinus mucosal inflammation. These same arguments have been put forward in terms of the concept of "one airway, one disease" which has emphasized the commonality of mucosal inflammation seen in the upper airway (rhinitis, sinusitis) and the lower airway (asthma). The biopsies will come from the middle turbinate. The latter structure has the same pseudostratified columnar epithelium and a virtually identical appearance to that of maxillary or ethmoid sinus mucosa. We have used biopsies from the middle turbinate in several previous studies of chronic sinusitis, primarily as a comparative tissue representing "healthy" sinus mucosa.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Biopsy
- Keywords
- CRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Active comparator | Not described Receives: Other: Biopsy |
| CRS | Experimental | Not described Receives: Other: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0hr
Secondary outcomes (1)
Characterization of bacterial microbial community
To characterize and compare the bacterial microbial community in the sinus mucosal tissues from 8 patients with refractory CRS versus 8 HC subjects.
Measured: 0hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startDec 2003
- Primary completionJul 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Responsible party
- Principal investigator, Daniel Hamilos MD, Massachusetts General Hospital
- Investigators
- Daniel Hamilos, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179139
- Sponsor's protocol ID
- 2003P002050
- Acronym
- FAMRI
- Status last verified
- May 2018
- First submitted
- 15 Apr 2010
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis of Chronic Sinusitis in Relationship to Tobacco Smoke Exposure
- ClinicalTrials.gov ID
- NCT01179139
- Acronym / sponsor ID
- FAMRI / 2003P002050
- Conditions
- Chronic Rhinosinusitis
- Keywords
- CRS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary
- Study start
- Dec 2003
- Primary completion
- Jul 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 pathogenic factors causing or contributing to chronic sinusitis. One of these factors is secondhand smoke (SS) exposure. However, several other factors are involved, including allergic, environmental, genetic and microbiologic factors and in any given patient, several of these factors may be contributing to the disease. One of our goals is to see whether specific patterns of inflammatory cells, cytokines or chemokines exist that can differentiate these causative factors and to help us to better understand their individual contributions to the disease.
Several inflammatory cells, cytokines and chemokines are present in chronically inflamed sinus tissue, and we believe they form the basis for the disease process. At present, we know very little about what drives them into the sinus tissues. We believe that the types of inflammatory cells, cytokines and chemokines elicited in this disease depend on the inciting stimulus.
Cigarette smoke has well-documented deleterious effects on respiratory mucosa that could promote the development of chronic sinusitis. These include reduction in normal mucociliary function; increased nasal airway resistance; induction of mucin gene expression and induction of chronic inflammation. In the proposed study, we will extend our previous findings to investigate the relationships between SS exposure and these inflammatory markers and also examine the relationship of these cytokines to the expression of particular mucins.
Extracts of cigarette smoke have been shown to induce numerous other proinflammatory effects on respiratory epithelial cells either in vivo or in vitro. In this study we will analyze the gene expression of inflammatory markers in a nasal mucosal biopsy. Our intent is to study sinusitis rather than rhinitis. Nonetheless, we will examine nasal rather than sinus mucosa largely owing to the difficulties posed by obtaining samples directly from the sinuses. Furthermore, recent consensus reports have emphasized the importance of viewing sinusitis as a continuum of nasal and sinus mucosal inflammation. These same arguments have been put forward in terms of the concept of "one airway, one disease" which has emphasized the commonality of mucosal inflammation seen in the upper airway (rhinitis, sinusitis) and the lower airway (asthma). The biopsies will come from the middle turbinate. The latter structure has the same pseudostratified columnar epithelium and a virtually identical appearance to that of maxillary or ethmoid sinus mucosa. We have used biopsies from the middle turbinate in several previous studies of chronic sinusitis, primarily as a comparative tissue representing "healthy" sinus mucosa.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | Active comparator | Other: Biopsy |
| CRS | Experimental | Other: Biopsy |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyPercutaneous 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. | Other | CRS, Healthy Control |
Primary outcome
Comparison of innate immune and inflammatory factor mRNA expression
Time frame: 0hr
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.
1 secondary outcome
Characterization of bacterial microbial community
Time frame: 0hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Hamilos, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Chronic Rhinosinusitis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of innate immune and inflammatory factor mRNA expression (time frame: 0hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.