Nasal PolypsNCT00835445
Biopsies and Polyps
An observational study of Nasal Polyps and Asthma, run by Laval University at 1 site in Canada.
Trial summary
Background: Nasal polyps are found in about 5% of asthmatic patients.A close link exists between the upper and lower airways and the concept of the "United Airways" has emerged mainly from studies on allergic rhinitis and asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Polyps, Asthma
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Sep 2009
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruited from the ENT clinic (Laval Hospital, Quebec City, Canada)
Who may be able to join
- For all subjects:
- Non smoking men or women aged 18 to 65 years old.
- Subjects will have nasal polyps as defined above.
- For asthmatic subjects:
- Subjects will have a history consistent with asthma according to the criteria of the ATS[18] defined on the basis of episodic or persistent chest tightness, wheeze or cough in the past 6 months. At entry into the study, FEV1 will be over 70% predicted.
- Asthma will have been stable for at least 3 months before entering the trial.
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- Asthma medication will have been stable for at least 1 month prior to the study.
- For non asthmatic subjects:
- A methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) over 16 mg/mL.
Who cannot join
- For all subjects:
- Smoking (current smoking) or ex-smoking (les than 6 months or history of more than 10 pack-year of smoking).
- Use of anti-leukotriene medication within the last 3 months.
- Use of systemic corticosteroids within the last 3 months.
- Use of anti-coagulant therapy.
- Recent (less than 1 month) upper or lower respiratory tract infection, any other condition that may interfere with the evaluations.
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- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile woman not using acceptable contraceptive measures, as judged by the investigator.
- Subjects unable to perform or with contraindications to the tests proposed.
- Subjects who are, in the opinion of the investigator, mentally or legally incapacitated thus preventing informed consent from being obtained.
- For asthmatic subjects:
- Unstable asthma shown by respiratory symptoms and B2-agonists need more than 3 times/week and nocturnal asthma symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasal Features of Subjects With Nasal Polyposis With or Without Asthma
Background: Nasal polyps are found in about 5% of asthmatic patients.A close link exists between the upper and lower airways and the concept of the "United Airways" has emerged mainly from studies on allergic rhinitis and asthma. However, other upper airway diseases, such as chronic sinusitis and nasal polyposis may influence lower airway diseases. As for nasal polyposis, eosinophils are the major effector cells in asthma and have been associated with a worsening of this condition.
Aim: To compare normal nasal mucosa and nasal polyp biopsies from subjects with nasal polyposis with or without asthma.
Hypothesis: Nasal polyps from asthmatic subjects show a more aggressive pro-inflammatory pattern of cytokine expression compared to nasal polyps from non asthmatic subjects, and therefore contribute to the development and severity of asthma.
Read the detailed description
The study will include 2 visits separated by a maximum of 7 days. During the first visit, subjects' characteristics will be documented by a locally validated questionnaire. Allergy skin prick tests, spirometry, methacholine inhalation test and induced sputum will also be done. Asthma and rhinitis control will be evaluated by locally validated questionnaires, the Asthma Control Scoring System (ACSS) and the Rhinitis Control Scoring System (RCSS), respectively. Nasal peak inspiratory flow (NPIF) and oral peak expiratory flow (PEF) will also be recorded to obtain the nasal blockage index (NBI). On the second visit, nasal biopsies will be taken.
- Conditions
- Nasal Polyps, Asthma
- Medical subject headings
- Nasal Polyps, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Asthmatics with polyps | |
| 2 | Non-asthmatics with polyps |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the difference in expression of IL-5 in nasal polyps and normal mucosa biopsies from asthmatic and non asthmatic subjects.
Measured: No time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJul 2007
- Primary completionOct 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, Centre de recherche, Hôpital Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835445
- Sponsor's protocol ID
- CER 20188
- Status last verified
- Dec 2010
- First submitted
- 30 Jan 2009
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Features of Subjects With Nasal Polyposis With or Without Asthma
- ClinicalTrials.gov ID
- NCT00835445
- Acronym / sponsor ID
- CER 20188
- Conditions
- Nasal Polyps, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 3 Feb 2009 (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.
Background: Nasal polyps are found in about 5% of asthmatic patients.A close link exists between the upper and lower airways and the concept of the "United Airways" has emerged mainly from studies on allergic rhinitis and asthma. However, other upper airway diseases, such as chronic sinusitis and nasal polyposis may influence lower airway diseases. As for nasal polyposis, eosinophils are the major effector cells in asthma and have been associated with a worsening of this condition.
Aim: To compare normal nasal mucosa and nasal polyp biopsies from subjects with nasal polyposis with or without asthma.
Hypothesis: Nasal polyps from asthmatic subjects show a more aggressive pro-inflammatory pattern of cytokine expression compared to nasal polyps from non asthmatic subjects, and therefore contribute to the development and severity of asthma.
Detailed description
The study will include 2 visits separated by a maximum of 7 days. During the first visit, subjects' characteristics will be documented by a locally validated questionnaire. Allergy skin prick tests, spirometry, methacholine inhalation test and induced sputum will also be done. Asthma and rhinitis control will be evaluated by locally validated questionnaires, the Asthma Control Scoring System (ACSS) and the Rhinitis Control Scoring System (RCSS), respectively. Nasal peak inspiratory flow (NPIF) and oral peak expiratory flow (PEF) will also be recorded to obtain the nasal blockage index (NBI). On the second visit, nasal biopsies will be taken.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Asthmatics with polyps |
| 2 | – | –Non-asthmatics with polyps |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruited from the ENT clinic (Laval Hospital, Quebec City, Canada)
Key inclusion criteria (9 listed)
- Non smoking men or women aged 18 to 65 years old.
- Subjects will have nasal polyps as defined above.
- Subjects will have a history consistent with asthma according to the criteria of the ATS[18] defined on the basis of episodic or persistent chest tightness, wheeze or cough in the past 6 months. At entry into the study, FEV1 will be over 70% predicted.
- Asthma will have been stable for at least 3 months before entering the trial.
- Asthma medication will have been stable for at least 1 month prior to the study.
Key exclusion criteria (11 listed)
- Smoking (current smoking) or ex-smoking (les than 6 months or history of more than 10 pack-year of smoking).
- Use of anti-leukotriene medication within the last 3 months.
- Use of systemic corticosteroids within the last 3 months.
- Use of anti-coagulant therapy.
- Recent (less than 1 month) upper or lower respiratory tract infection, any other condition that may interfere with the evaluations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint will be the difference in expression of IL-5 in nasal polyps and normal mucosa biopsies from asthmatic and non asthmatic subjects.
Time frame: No time frame
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 7 Jan 2011.
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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.
Louis-Philippe Boulet, MD principal investigator
Centre de recherche, Hôpital Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Polyps and Asthma, run by Laval University at 1 site in Canada.
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 9 inclusion and 11 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 7 Jan 2011. 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 Canada. 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?
The primary endpoint will be the difference in expression of IL-5 in nasal polyps and normal mucosa biopsies from asthmatic and non asthmatic subjects. (time frame: No time frame). 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 7 Jan 2011.