Biopsies and Polyps
| Tracking Information | |||||
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| First Received Date ICMJE | January 30, 2009 | ||||
| Last Updated Date | January 6, 2011 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00835445 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Biopsies and Polyps | ||||
| Official Title ICMJE | Nasal Features of Subjects With Nasal Polyposis With or Without Asthma | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Nasal polyps (Biopsies) Normal nasal mucosa (Biopsies) Sputum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Recruited from the ENT clinic (Laval Hospital, Quebec City, Canada) |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 25 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: For all subjects:
For asthmatic subjects:
For non asthmatic subjects:
Exclusion Criteria: For all subjects:
For asthmatic subjects:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00835445 | ||||
| Other Study ID Numbers ICMJE | CER 20188 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Louis-Philippe Boulet, Hôpital Laval | ||||
| Study Sponsor ICMJE | Laval University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Laval University | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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