Biopsies and Polyps

This study has been completed.
Sponsor:
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00835445
First received: January 30, 2009
Last updated: January 6, 2011
Last verified: December 2010
  Purpose

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.


Condition
Nasal Polyps
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Nasal Features of Subjects With Nasal Polyposis With or Without Asthma

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

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


Enrollment: 25
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Asthmatics with polyps
2
Non-asthmatics with polyps

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835445

Locations
Canada, Quebec
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Louis-Philippe Boulet, MD Centre de recherche, Hôpital Laval
  More Information

No publications provided

Responsible Party: Louis-Philippe Boulet, Hôpital Laval
ClinicalTrials.gov Identifier: NCT00835445     History of Changes
Other Study ID Numbers: CER 20188
Study First Received: January 30, 2009
Last Updated: January 6, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Asthma
Nasal Polyps
Polyps
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014