N/A N=45 Prevention

Nasal Allergen Challenge in Rhinitic Subjects

Asthma · Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT01286129 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Change in Sputum Eosinophils Following Allergen Challenge — 5.6; 2.0; 6.0; 1.3 percentage of sputum eosinophils

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nasal allergen challenge (Procedure)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Laval University
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Sputum Eosinophils Following Allergen Challenge	5.6; 2.0; 6.0; 1.3; 4.1; 1.6	—
SECONDARY Change in Nasal Lavage Eosinophils After Allergen Challenge	2.1; 1.3; 7.5; 3.0; 15.7; 15.5	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01286129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.