Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment

Not Applicable

• Conditions: Allergic Asthma
• Interventions: Drug: Placebo; Drug: Triamcinolone Acetonide

• Registration Number: NCT03431961
• Lead Sponsor: Gail Gauvreau

Brief Summary

Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. One cohort will have intranasal corticosteroid intervention.

Detailed Description

Eligible subjects will be randomized 1:1 to Cohort A or Cohort B. Each cohort will undergo 3 nasal challenges, each separated by 3 weeks. Cohort A will undergo 2 nasal allergen challenges, and 1 nasal diluent challenge. TNSS, PNIF, spirometry, and samples of blood, urine and nasal secretions will be collected until 24h post-challenge to assess reproducibility. Cohort B will undergo 3 nasal allergen challenges; one of the challenge will be conducted after 14 days treatment with placebo, and one challenge will be conducted after 14 days treatment with triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily for a total daily dose of 440 mcg. TNSS, PNIF, spirometry, and samples of blood, urine, nasal secretions will be collected until 24h post-challenge to determine reproducibility, and nasal tissue will be collected 24h post-challenge to determine effect of steroid treatment.

Study Timeline

• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-13
• Study Start: 2018-03-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02
• Primary Completion: 2019-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• allergic rhinitis + mild asthma

Exclusion Criteria

• other respiratory disease
• any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0.9% normal saline administered twice daily for 14 days
Intranasal Corticosteroid	Triamcinolone Acetonide	Triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily (for a total daily dose of 440 mcg) for 14 days

Primary Outcome Measures

Name	Time	Method
Cellular inflammation	24 hours after nasal allergen challenge	Nasal eosinophils

Trial Locations

Locations (1)

Cardio- Respiratory Research Laboratory, Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada