NCT03431961

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Gail Gauvreau · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	Triamcinolone Acetonide	220 mcg administered twice daily for 14 days
DRUG	Placebo	twice daily for 14 days

Timeline

• Start date: 2018-03-07
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2018-02-13
• Last updated: 2018-08-02

Locations

1 site across 1 country: Canada