NCT00835445

Completed

Biopsies and Polyps

Laval University Source

Compare

Other study identifiers

Sponsor study identifier

CER 20188

Study Type

observational

Actual enrollment (reported)

25

Locations

1 country

Sites

1

Timeline

Study Start

July 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2008

Actual (reported)

Study Completion

September 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 25 participants
Study completion date: September 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 2008
Actual (reported)
First Submitted
January 30, 2009
Actual (reported)
First Posted
February 3, 2009
Actual (reported)
Study Completion
September 2009
Actual (reported)

Last Updated: January 7, 2011
Status Verified: December 2010
Last Update Submitted: January 6, 2011

Conditions

Asthma Nasal Polyps

Outcome Measures

Primary Outcomes (1)

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.
No time frame

Study Arms (2)

1

Asthmatics with polyps

2

Non-asthmatics with polyps

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Recruited from the ENT clinic (Laval Hospital, Quebec City, Canada)

You may qualify if:

For all subjects:

Sponsors & Collaborators

Laval University
Otherlead

Study Sites (1)

Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal polyps (Biopsies) Normal nasal mucosa (Biopsies) Sputum

MeSH Terms

Conditions

Nasal PolypsAsthma

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Louis-Philippe Boulet, MD
Centre de recherche, Hôpital Laval
PRINCIPAL INVESTIGATOR

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 3, 2009

Study Start

July 2007

Date type not reported

This date has not been verified as actual or estimated.

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Phase 3Completed

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NCT00509197

Should Non-eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?

Not ApplicableTerminated

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.

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.

You may not qualify if:

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.
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.

Contact the study team to confirm eligibility.

Primary Completion

October 2008

Actual (reported)

Study Completion

September 2009

Actual (reported)

Last Updated

January 7, 2011

Record last verified: 2010-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00835445
Data provider: ClinicalTrials.gov
Source updated: 2011-01-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:44 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations