NCT00835445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 7, 2011

Status Verified

December 1, 2010

Enrollment Period

1.3 years

First QC Date

January 30, 2009

Last Update Submit

January 6, 2011

Conditions

Nasal PolypsAsthma

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:
  • 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.

Sponsors & Collaborators

Study Sites (1)

Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

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

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 1, 2007

Primary Completion

October 1, 2008

Study Completion

September 1, 2009

Last Updated

January 7, 2011

Record last verified: 2010-12

Locations

CA(1)