NCT01286129

Brief Summary

Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of rhinitis, and multiple challenges may more adequately approximate natural exposure. Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory parameters in rhinitics with or without asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable asthma

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

November 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 1, 2013

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

January 13, 2011

Results QC Date

March 29, 2012

Last Update Submit

January 15, 2019

Conditions

AsthmaAllergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Change in Sputum Eosinophils Following Allergen Challenge

    Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.

    At 7 hours post first and last challenge compared to baseline

Secondary Outcomes (1)

  • Change in Nasal Lavage Eosinophils After Allergen Challenge

    At 7 hours post first and last challenge compared to baseline

Study Arms (2)

Allergic asthmatic

ACTIVE COMPARATOR

Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.

Procedure: Nasal allergen challenge

Allergic rhinitic without asthma

ACTIVE COMPARATOR

Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.

Procedure: Nasal allergen challenge

Interventions

Nasal allergen challengePROCEDURE

Allergen sprayed into nostrils. Allergen used will be house dust mite or cat allergen. Allergens will be given in increasing ten-fold dilutions until a positive response occurs.

Allergic asthmaticAllergic rhinitic without asthma

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • To have a positive reaction to one or more allergen on prick tests.
  • Non smokers
  • No respiratory track infection for at least one month prior to the study.
  • Positive reaction to cat hair and/or house dust mite (Dermatophagoides pteronyssinus) aeroallergens on allergy skin prick tests and report rhinitis symptoms when exposed to an environment containing this allergen.
  • Asthmatic subjects using only inhaled beta-2 agonists on an as needed basis for their asthma treatment.
  • Asthmatic subjects with a history of asthma of at least 6 months.
  • Asthmatic subjects with PC20 methacholine lower or equal to 8 mg/ml.
  • Allergic rhinitic subjects never experienced any asthma symptoms or took any asthma medication in the past.
  • Allergic rhinitic subjects with a provocative concentration of methacholine (PC20 higher than 16 mg/ml.

You may not qualify if:

  • Smokers or ex smokers less than 6 months or more than 10 pack-years.
  • Asthmatic subjects using or used in the past 3 months inhaled or oral corticosteroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • Rousseau MC, Boulay ME, Goronfolah L, Denburg J, Keith P, Boulet LP. Comparative responses to nasal allergen challenge in allergic rhinitic subjects with or without asthma. Allergy Asthma Clin Immunol. 2011 Apr 20;7(1):8. doi: 10.1186/1710-1492-7-8.

    PMID: 21507261DERIVED

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Louis-Philippe Boulet, principal investigator
Organization
IUCPQ
lpboulet@med.ulaval.ca
418-656-4747

Study Officials

  • Louis-Philippe Boulet, MD

    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 31, 2011

Study Start

November 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 1, 2019

Results First Posted

July 1, 2013

Record last verified: 2019-01

Locations

CA(1)